xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002685</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00103602</org_study_id>
      <nct_id>NCT06002685</nct_id>
    </id_info>
    <brief_title>Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention</brief_title>
    <official_title>Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Harvard School of Public Health (HSPH)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Maryland, Baltimore</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized controlled trial is to evaluate the impacts of an&#xD;
        attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home&#xD;
        Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood&#xD;
        illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at&#xD;
        enrollment). It is hypothesized that children randomized to ABC will have better health&#xD;
        outcomes in comparison to the HBOW control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed RCT will test the impacts of the Attachment Biobehavioral Catch-up (ABC)&#xD;
        intervention program on child health outcomes. A total of 260 male and female infants will be&#xD;
        enrolled in this study, with an age range of 8-12 months (infant) and 13 months- 23 months&#xD;
        (toddler). This study will enroll primiparous and multiparous mothers who identify as Latina,&#xD;
        speak English or Spanish, and have a 9-month-old child enrolled in Medicaid at the start of&#xD;
        the study. Participants will be recruited in collaboration with the Children's Medical&#xD;
        Practice (CMP) at Johns Hopkins Bayview Medical Center and matriculated on a rolling basis.&#xD;
        Each participant will participate for approximately 15 months; the time required to complete&#xD;
        the Time 1 assessment, either 10-week condition, and the two post-intervention assessments.&#xD;
        The entire study is anticipated to be completed in 5 years. This RCT will test maternal&#xD;
        sensitivity and child stress regulation as mediators of intervention effects. It will also&#xD;
        examine the extent to which sociocultural factors moderate the effects of ABC. Behavioral&#xD;
        methods and procedures will include surveys/questionnaires, audio/video recordings,&#xD;
        individual or group behavioral observations, psychosocial or behavioral interventions, and&#xD;
        other psychosocial or behavioral procedures. This RCT is powered to detect small-medium&#xD;
        intervention effects (Cohen's d's= 0.35 - 0.50). These effect sizes align with previous&#xD;
        studies, which have shown small to large effects on maternal sensitivity (d's = 0.23 - 0.77)&#xD;
        and small to medium effects on main and moderated child behavioral stress regulation (d's=&#xD;
        0.15 - 0.48) and child physiological (cortisol) regulation, via maternal sensitivity&#xD;
        (d=-0.36). For .80 power or higher and a two-tailed significance level of .05, power analyses&#xD;
        performed using Optimal Design, Webpower, and Gpower software indicated a post-attrition&#xD;
        sample size of N=221 will adequately detect main, mediated, and moderated effects of&#xD;
        comparable size. Analyses will be conducted in SAS 9.4, SPSS 25.0, and Mplus 8 and will&#xD;
        include regression and structural equation models. Missing data will be accommodated using&#xD;
        multiple imputations and/or full information maximum likelihood (FIML) and estimators that&#xD;
        are robust to non-normality when missing data are present (e.g., MLR). Data safety monitoring&#xD;
        will be conducted by the Principal Investigators and the external Data Safety and Monitoring&#xD;
        Board, who will review adverse events, enrollment numbers, procedure reports, raw data,&#xD;
        outcomes, preliminary analyses, and other data which will be completed on an ongoing basis&#xD;
        and reported to the IRB and a sponsor. Study findings stand to inform the nature and timing&#xD;
        of preventive interventions to reduce health disparities that disproportionately impact&#xD;
        Latino families and will advance understanding of early social influences that promote health&#xD;
        development across the lifespan.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">January 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A 2-group, pre-and post-test experimental design (N = 260; 130 in each group) will be employed. All eligible mother-child dyads will be randomly assigned to receive the intervention, Attachment Biobehavioral Catch- up (ABC),or the control, Home-Book-of-the- Week (HBOW). Assessments will take place in the participant's home and on the phone.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>2 tasks will be coded by research assistants masked to assigned intervention condition.&#xD;
  Child Stress Regulation: Using video-recorded data collected at Times 1 and 2, blinded coders will rate the child's emotion regulation strategies in the context of mild stressors. Coders will use the Laboratory Temperament Assessment Battery (Lab-TAB) to rate the presence/absence of the following behaviors every 5 seconds: looks to mother, communicative gestures, looks to environment; and self-stimulation. In keeping with our own and others' previous data reduction in this domain, we will compute two proportion-score composites for mother-oriented regulation and self-soothing regulation. Coders will rate children's emotional re-activity every 5 seconds to analyze emotional reactivity as a covariate.&#xD;
  Sensitive Parenting Behaviors: At Times 1 and 2, blinded coders will collect observational assessments of sensitive parenting behaviors in 3 contexts: (a) play, (b) child distress, and (c) feeding.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)</measure>
      <time_frame>This data will be gathered at Time 1 (9 months).</time_frame>
      <description>This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)</measure>
      <time_frame>This data will be gathered at Time 2 (15 months).</time_frame>
      <description>This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)</measure>
      <time_frame>This data will be gathered at Time 3 (24 months).</time_frame>
      <description>This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rapid Weight Gain</measure>
      <time_frame>This data will be gathered at Time 1 (9 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rapid Weight Gain</measure>
      <time_frame>This data will be gathered at Time 2 (15 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rapid Weight Gain</measure>
      <time_frame>This data will be gathered at Time 3 (24 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive Speech Delay</measure>
      <time_frame>This data will be gathered at Time 1 (9 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive Speech Delay</measure>
      <time_frame>This data will be gathered at Time 2 (15 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive Speech Delay</measure>
      <time_frame>This data will be gathered at Time 3 (24 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Other Pediatric Health Problem(s)</measure>
      <time_frame>This data will be gathered at Time 1 (9 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Other Pediatric Health Problem(s)</measure>
      <time_frame>This data will be gathered at Time 2 (15 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Other Pediatric Health Problem(s)</measure>
      <time_frame>This data will be gathered at Time 3 (24 months).</time_frame>
      <description>This outcome will be assessed through a review of the children's Electronic Health Record.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Low Grade Inflammation</measure>
      <time_frame>This data will be gathered at Time 3 (24 months).</time_frame>
      <description>This outcome will be assessed via markers of C-reactive protein (CRP) and interleukin-6 (IL-6) through a collection of blood spots using a traditional finger-prick. Blood spot collection is required at the 24-month pediatric well-child visit for all Baltimore City residents.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>This data will be gathered at Time 1 (9 months).</time_frame>
      <description>This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>This data will be gathered at Time 2 (15 months).</time_frame>
      <description>This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>This data will be gathered at Time 3 (24 months).</time_frame>
      <description>This outcome will be collected through mothers reports about their children's current length and weight. In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep: Age 9 months</measure>
      <time_frame>Sleep data will be gathered at Time 1 (age 9 months).</time_frame>
      <description>This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep: At 9 months</measure>
      <time_frame>Sleep data will be gathered at Time 1 (at 9 months).</time_frame>
      <description>An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep: Age 15 months</measure>
      <time_frame>Sleep data will be gathered at Time 2 (age 15 months).</time_frame>
      <description>This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep: At 15 months</measure>
      <time_frame>Sleep data will be gathered at Time 2 (at 15 months).</time_frame>
      <description>An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep: Age 24 months</measure>
      <time_frame>Sleep data will be gathered at Time 3 (age 24 months).</time_frame>
      <description>This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep: At 24 months</measure>
      <time_frame>Sleep data will be gathered at Time 3 (at 24 months).</time_frame>
      <description>An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Maternal Sensitivity during Semi-Structured Play</measure>
      <time_frame>This data will be collected at Time 1 (9 months).</time_frame>
      <description>This outcome will be assessed with a 15-minute &quot;Three Bag&quot; interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.</description>
    </other_outcome>
    <other_outcome>
      <measure>Maternal Sensitivity during Semi-Structured Play</measure>
      <time_frame>This data will be collected at Time 2 (15 months).</time_frame>
      <description>This outcome will be assessed with a 15-minute &quot;Three Bag&quot; interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.</description>
    </other_outcome>
    <other_outcome>
      <measure>Maternal Sensitivity to Child Distress</measure>
      <time_frame>This data will be collected at Time 1 (9 months).</time_frame>
      <description>This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute &quot;baseline&quot; period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother &quot;reunion&quot; when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' &quot;food to soothe&quot; behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.</description>
    </other_outcome>
    <other_outcome>
      <measure>Maternal Sensitivity to Child Distress</measure>
      <time_frame>This data will be collected at Time 2 (15 months).</time_frame>
      <description>This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute &quot;baseline&quot; period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother &quot;reunion&quot; when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' &quot;food to soothe&quot; behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.</description>
    </other_outcome>
    <other_outcome>
      <measure>Maternal Sensitivity during Feeding</measure>
      <time_frame>This data will be collected at Time 1 (9 months).</time_frame>
      <description>This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.</description>
    </other_outcome>
    <other_outcome>
      <measure>Maternal Sensitivity during Feeding</measure>
      <time_frame>This data will be collected at Time 2 (15 months).</time_frame>
      <description>This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.</description>
    </other_outcome>
    <other_outcome>
      <measure>Child Stress Regulation: Age 9 months</measure>
      <time_frame>This data will be collected at Time 1 (9 months).</time_frame>
      <description>Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.</description>
    </other_outcome>
    <other_outcome>
      <measure>Child Stress Regulation: Age 15 months</measure>
      <time_frame>This data will be collected at Time 2 (age 15 months).</time_frame>
      <description>Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate.</description>
    </other_outcome>
    <other_outcome>
      <measure>Child Stress Regulation: At 15 months</measure>
      <time_frame>This data will be collected at Time 2 (at 15 months).</time_frame>
      <description>The child's emotional dysregulation will be assessed by administrating mothers the Infant-Toddler Social and Emotional Assessment (ITSEA). The following three ITSEA subscales will be examined: internalizing, externalizing, and dysregulation. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">260</enrollment>
    <condition>Respiratory Disease</condition>
    <condition>Inflammation</condition>
    <condition>Insufficient Sleep</condition>
    <condition>Digestive Disease</condition>
    <condition>Skin Conditions</condition>
    <condition>Body Mass Index</condition>
    <condition>Infections</condition>
    <condition>Allergies</condition>
    <condition>Congestion</condition>
    <condition>Antibiotic Use</condition>
    <condition>Overweight and Obesity</condition>
    <arm_group>
      <arm_group_label>Attachment and Biobehavioral Catch-up (ABC) program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Home-Based Book-of-the-Week (HBOW) program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Attachment and Biobehavioral Catch-Up</intervention_name>
      <description>The ABC program consists of 10 one-hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Principal intervention activities include a discussion of basic attachment principles, guided practice of new parenting behaviors, and a review of video clips from previous sessions to help reinforce parenting targets. The parent coach promotes (a) nurturance, especially in response to distress; (b) following the child's lead with delight; and (c) avoiding frightening caregiving behavior. As specified by the ABC protocol, any/all other family members will be invited to observe or participate in each ABC session Each full-time ABC parent coach will serve 8 to 10 families at a time (i.e., complete 8-10 hourly ABC visits per week).</description>
      <arm_group_label>Attachment and Biobehavioral Catch-up (ABC) program</arm_group_label>
      <other_name>ABC</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Home-Based Book-of-the-Week</intervention_name>
      <description>The HBOW program is an active control condition developed by PI Berlin. It consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. During each of the 10 weeks, a trained RA will visit each HBOW mother to drop off the book and to ask briefly about the mother's and child's well-being (using a standard set of questions). Thus, this condition will parallel the intervention condition in duration (number of weeks) and structure, although it will be less intensive in terms of participant contact time per visit.</description>
      <arm_group_label>Home-Based Book-of-the-Week (HBOW) program</arm_group_label>
      <other_name>HBOW</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Biological mothers&#xD;
  &#xD;
            -  Identify as Latina&#xD;
  &#xD;
            -  Speak English or Spanish&#xD;
  &#xD;
            -  Primiparous and multiparous&#xD;
  &#xD;
            -  Have a 9-month-old child enrolled in Medicaid&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children born prematurely (gestational age &lt; 37 weeks)&#xD;
  &#xD;
            -  Children who have major complex medical conditions (e.g., heart or autoimmune&#xD;
               conditions) that could interfere with participation in intervention sessions and/or&#xD;
               research assessments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Months</minimum_age>
      <maximum_age>12 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Berlin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Natalie Slopen, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Harvard School of Public Health (HSPH)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cathi Propper, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Psychology and Neuroscience at UNC Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lisa Berlin, PhD</last_name>
      <phone>410.706.6392</phone>
      <email>lberlin@ssw.umaryland.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Roderick Rose, PhD</last_name>
      <phone>410.706.7023</phone>
      <email>rrose@ssw.umaryland.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Maryland</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lisa Berlin, PhD</last_name>
        <phone>410-706-6392</phone>
        <email>LBerlin@ssw.umaryland.edu</email>
      </contact>
      <contact_backup>
        <last_name>Roderick Rose, PhD</last_name>
        <phone>410.706.7023</phone>
        <email>rrose@ssw.umaryland.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Lisa Berlin, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Dozier M, Bernard K. Coaching parents of vulnerable infants: The Attachment and Biobehavioral Catch-Up Approach. Guilford Press; 2019.</citation>
    </reference>
    <reference>
      <citation>Berlin LJ, Martoccio TL, Jones Harden B. Improving early head start's impacts on parenting through attachment-based intervention: A randomized controlled trial. Dev Psychol. 2018 Dec;54(12):2316-2327. doi: 10.1037/dev0000592. Epub 2018 Oct 18.</citation>
      <PMID>30335427</PMID>
    </reference>
    <reference>
      <citation>Urquhart A, Clarke P. US racial/ethnic disparities in childhood asthma emergent health care use: National Health Interview Survey, 2013-2015. J Asthma. 2020 May;57(5):510-520. doi: 10.1080/02770903.2019.1590588. Epub 2019 Apr 8.</citation>
      <PMID>30958048</PMID>
    </reference>
    <reference>
      <citation>Kaar JL, Schmiege SJ, Kalkwarf HJ, Woo JG, Daniels SR, Simon SL. Longitudinal Assessment of Sleep Trajectories during Early Childhood and Their Association with Obesity. Child Obes. 2020 Apr;16(3):211-217. doi: 10.1089/chi.2019.0126. Epub 2019 Nov 21.</citation>
      <PMID>31750742</PMID>
    </reference>
    <reference>
      <citation>Berlin LJ, Martoccio TL, Bryce CI, Jones Harden B. Improving infants' stress-induced cortisol regulation through attachment-based intervention: A randomized controlled trial. Psychoneuroendocrinology. 2019 May;103:225-232. doi: 10.1016/j.psyneuen.2019.01.005. Epub 2019 Jan 4.</citation>
      <PMID>30716550</PMID>
    </reference>
    <reference>
      <citation>Cespedes EM, Rifas-Shiman SL, Redline S, Gillman MW, Pena MM, Taveras EM. Longitudinal associations of sleep curtailment with metabolic risk in mid-childhood. Obesity (Silver Spring). 2014 Dec;22(12):2586-92. doi: 10.1002/oby.20894. Epub 2014 Sep 19.</citation>
      <PMID>25234485</PMID>
    </reference>
    <reference>
      <citation>Dowd JB, Zajacova A, Aiello A. Early origins of health disparities: burden of infection, health, and socioeconomic status in U.S. children. Soc Sci Med. 2009 Feb;68(4):699-707. doi: 10.1016/j.socscimed.2008.12.010. Epub 2009 Jan 17.</citation>
      <PMID>19152993</PMID>
    </reference>
    <reference>
      <citation>Meltzer LJ, Pugliese CE. Sleep in young children with asthma and their parents. J Child Health Care. 2017 Sep;21(3):301-311. doi: 10.1177/1367493517712064. Epub 2017 Jun 5.</citation>
      <PMID>29119809</PMID>
    </reference>
    <reference>
      <citation>El-Sheikh M, Buckhalt JA, Granger DA, Erath SA, Acebo C. The association between children's sleep disruption and salivary interleukin-6. J Sleep Res. 2007 Jun;16(2):188-97. doi: 10.1111/j.1365-2869.2007.00593.x.</citation>
      <PMID>17542949</PMID>
    </reference>
    <reference>
      <citation>Hepworth AD, Berlin LJ, Salas K, Pardue-Kim M, Martoccio TL, Jones Harden B. Increasing maternal sensitivity to infant distress through attachment-based intervention: a randomized controlled trial. Attach Hum Dev. 2021 Dec;23(6):953-968. doi: 10.1080/14616734.2020.1834592. Epub 2020 Oct 27.</citation>
      <PMID>33108981</PMID>
    </reference>
    <reference>
      <citation>Worobey J, Lopez MI, Hoffman DJ. Maternal behavior and infant weight gain in the first year. J Nutr Educ Behav. 2009 May-Jun;41(3):169-75. doi: 10.1016/j.jneb.2008.06.005.</citation>
      <PMID>19411050</PMID>
    </reference>
    <reference>
      <citation>Hodges EA, Propper CB, Estrem H, Schultz MB. Feeding During Infancy: Interpersonal Behavior, Physiology, and Obesity Risk. Child Dev Perspect. 2020 Sep;14(3):185-191. doi: 10.1111/cdep.12376. Epub 2020 Jul 14.</citation>
      <PMID>34707686</PMID>
    </reference>
    <reference>
      <citation>Pachter LM, Coll CG. Racism and child health: a review of the literature and future directions. J Dev Behav Pediatr. 2009 Jun;30(3):255-63. doi: 10.1097/DBP.0b013e3181a7ed5a.</citation>
      <PMID>19525720</PMID>
    </reference>
    <reference>
      <citation>Williams DR, Lawrence JA, Davis BA. Racism and Health: Evidence and Needed Research. Annu Rev Public Health. 2019 Apr 1;40:105-125. doi: 10.1146/annurev-publhealth-040218-043750. Epub 2019 Feb 2.</citation>
      <PMID>30601726</PMID>
    </reference>
    <reference>
      <citation>Williams DR, Lawrence JA, Davis BA, Vu C. Understanding how discrimination can affect health. Health Serv Res. 2019 Dec;54 Suppl 2(Suppl 2):1374-1388. doi: 10.1111/1475-6773.13222. Epub 2019 Oct 29.</citation>
      <PMID>31663121</PMID>
    </reference>
    <reference>
      <citation>Coll CG, Magnuson K. Cultural Differences as Sources of Developmental. Handbook of early childhood intervention. 2000;</citation>
    </reference>
    <reference>
      <citation>Garcia Coll C, Lamberty G, Jenkins R, McAdoo HP, Crnic K, Wasik BH, Vazquez Garcia H. An integrative model for the study of developmental competencies in minority children. Child Dev. 1996 Oct;67(5):1891-914.</citation>
      <PMID>9022222</PMID>
    </reference>
    <reference>
      <citation>Coll CG, Magnuson K. The psychological experience of immigration: A developmental perspective. Immigration and the family: Research and policy on US immigrants. 1997:91-131.</citation>
    </reference>
    <reference>
      <citation>Hepworth AD, Berlin LJ, Martoccio TL, Jones Harden B. Maternal attachment style, sensitivity, and infant obesity risk in low-income, Latino families. Attach Hum Dev. 2021 Feb;23(1):75-89. doi: 10.1080/14616734.2020.1729214. Epub 2020 Mar 4.</citation>
      <PMID>32126901</PMID>
    </reference>
    <reference>
      <citation>Simons SM, Cillessen FH, Hazelzet JA. Determinants of a successful problem list to support the implementation of the problem-oriented medical record according to recent literature. BMC Med Inform Decis Mak. 2016 Aug 2;16:102. doi: 10.1186/s12911-016-0341-0.</citation>
      <PMID>27485127</PMID>
    </reference>
    <reference>
      <citation>McDade TW. Measuring immune function: markers of cell-mediated immunity and inflammation in dried blood spots. In: Ice GH, James GD, eds. Measuring Stress in Humans: A Practical Guide for the Field. Cambridge Univ Press; 2007:181-207. Cambridge Studies in Biological and Evolutionary Anthropology.</citation>
    </reference>
    <reference>
      <citation>McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007 Nov;44(4):899-925. doi: 10.1353/dem.2007.0038.</citation>
      <PMID>18232218</PMID>
    </reference>
    <reference>
      <citation>Ohri-Vachaspati P, Acciai F, DeLia D, Lloyd K, Yedidia MJ. Accuracy of Parent-Measured and Parent-Estimated Heights and Weights in Determining Child Weight Status. JAMA Pediatr. 2019 Aug 1;173(8):793-795. doi: 10.1001/jamapediatrics.2019.1545.</citation>
      <PMID>31206143</PMID>
    </reference>
    <reference>
      <citation>Woo JG, Daniels SR. Assessment of Body Mass Index in Infancy: It Is Time to Revise Our Guidelines. J Pediatr. 2019 Jan;204:10-11. doi: 10.1016/j.jpeds.2018.09.025. Epub 2018 Oct 5. No abstract available.</citation>
      <PMID>30297288</PMID>
    </reference>
    <reference>
      <citation>Acebo C, Sadeh A, Seifer R, Tzischinsky O, Wolfson AR, Hafer A, Carskadon MA. Estimating sleep patterns with activity monitoring in children and adolescents: how many nights are necessary for reliable measures? Sleep. 1999 Feb 1;22(1):95-103. doi: 10.1093/sleep/22.1.95. Erratum In: Sleep 1999 Mar 15;22(2):143.</citation>
      <PMID>9989370</PMID>
    </reference>
    <reference>
      <citation>Buckhalt JA, El-Sheikh M, Keller P. Children's sleep and cognitive functioning: race and socioeconomic status as moderators of effects. Child Dev. 2007 Jan-Feb;78(1):213-31. doi: 10.1111/j.1467-8624.2007.00993.x.</citation>
      <PMID>17328701</PMID>
    </reference>
    <reference>
      <citation>Adams EL, Master L, Buxton OM, Savage JS. A longitudinal study of sleep-wake patterns during early infancy using proposed scoring guidelines for actigraphy. Sleep Med. 2019 Nov;63:98-105. doi: 10.1016/j.sleep.2019.05.017. Epub 2019 Jun 8.</citation>
      <PMID>31610384</PMID>
    </reference>
    <reference>
      <citation>Adams EL, Savage JS, Master L, Buxton OM. Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy. Sleep Med. 2020 Sep;73:238-245. doi: 10.1016/j.sleep.2020.07.003. Epub 2020 Jul 14.</citation>
      <PMID>32861189</PMID>
    </reference>
    <reference>
      <citation>Meltzer LJ, Mindell JA. Impact of a child's chronic illness on maternal sleep and daytime functioning. Arch Intern Med. 2006 Sep 18;166(16):1749-55. doi: 10.1001/archinte.166.16.1749.</citation>
      <PMID>16983054</PMID>
    </reference>
    <reference>
      <citation>Mindell JA, Gould RA, Tikotzky L, Leichman ES, Walters RM. Corrigendum to &quot;Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R)&quot; [Sleep Med 63 (2019) 106-114]. Sleep Med. 2020 Mar;67:286. doi: 10.1016/j.sleep.2019.12.012. Epub 2020 Feb 6. No abstract available.</citation>
      <PMID>32035744</PMID>
    </reference>
    <reference>
      <citation>Mills-Koonce WR, Cox M. Qualitative ratings for parent-child interaction at 3-48 months of age. (Unpublished coding scales). 2013;</citation>
    </reference>
    <reference>
      <citation>Ursache A, Blair C, Granger DA, Stifter C, Voegtline K; Family Life Project Investigators. Behavioral reactivity to emotion challenge is associated with cortisol reactivity and regulation at 7, 15, and 24 months of age. Dev Psychobiol. 2014 Apr;56(3):474-88. doi: 10.1002/dev.21113. Epub 2013 Aug 5.</citation>
      <PMID>23918193</PMID>
    </reference>
    <reference>
      <citation>Leerkes EM, Nayena Blankson A, O'Brien M. Differential effects of maternal sensitivity to infant distress and nondistress on social-emotional functioning. Child Dev. 2009 May-Jun;80(3):762-75. doi: 10.1111/j.1467-8624.2009.01296.x.</citation>
      <PMID>19489902</PMID>
    </reference>
    <reference>
      <citation>Blair C, Ursache A, Mills-Koonce R, Stifter C, Voegtline K, Granger DA; Family Life Project Investigators. Emotional reactivity and parenting sensitivity interact to predict cortisol output in toddlers. Dev Psychol. 2015 Sep;51(9):1271-7. doi: 10.1037/dev0000031. Epub 2015 Jul 20.</citation>
      <PMID>26192038</PMID>
    </reference>
    <reference>
      <citation>Owen M. The NICHD study of early child care mother-infant interaction scales. Unpublished manuscript Dallas, TX: Timberlawn Psychiatric Research Foundation. 1992;</citation>
    </reference>
    <reference>
      <citation>NICHD Early Child Care Research Network. Characteristics and quality of child care for toddlers and preschoolers. Applied Developmental Science. 2000;4(3):116-135.</citation>
    </reference>
    <reference>
      <citation>Stifter CA, Moding KJ. Understanding and measuring parent use of food to soothe infant and toddler distress: A longitudinal study from 6 to 18 months of age. Appetite. 2015 Dec;95:188-96. doi: 10.1016/j.appet.2015.07.009. Epub 2015 Jul 9.</citation>
      <PMID>26164121</PMID>
    </reference>
    <reference>
      <citation>Goldsmith HH, Rothbart M. The laboratory temperament assessment battery (Locomotor Version 3.1). Madison, WI: University of Wisconsin-Madison. 1999;</citation>
    </reference>
    <reference>
      <citation>Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.</citation>
      <PMID>14561058</PMID>
    </reference>
    <reference>
      <citation>Carter AS, Briggs-Gowan MJ. ITSEA: Infant-toddler social and emotional assessment examiner's manual. San Antonio, TX: PsychCorp. 2006;</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
      <investigator_full_name>Lisa Berlin</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Digestive System Diseases</mesh_term>
      <mesh_term>Gastrointestinal Diseases</mesh_term>
      <mesh_term>Respiratory Tract Diseases</mesh_term>
      <mesh_term>Respiration Disorders</mesh_term>
      <mesh_term>Sleep Deprivation</mesh_term>
      <mesh_term>Skin Diseases</mesh_term>
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected IPD.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>3-5yrs after initial study publications.</ipd_time_frame>
      <ipd_access_criteria>There will be only one master database in which participants' ID numbers and personal identifying information are linked. Only Dr. Berlin and the staff members who are directly involved in the data collection and processing will have access to this database. Electronic data will be stored on a secure network, with password protection such that only authorized users will have access to the file server. Any original data documents such as consent forms will be kept in locked compartments separate from identifying documentation. All electronic and paper files that contain identifying information will be destroyed at the conclusion of the research. Published data will not permit the identification of individuals</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002685
  org study id: HP-00103602
  nct id: NCT06002685
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to evaluate the impacts of an
        attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home
        Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood
        illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at
        enrollment). It is hypothesized that children randomized to ABC will have better health
        outcomes in comparison to the HBOW control group.
  The proposed RCT will test the impacts of the Attachment Biobehavioral Catch-up (ABC)
        intervention program on child health outcomes. A total of 260 male and female infants will be
        enrolled in this study, with an age range of 8-12 months (infant) and 13 months- 23 months
        (toddler). This study will enroll primiparous and multiparous mothers who identify as Latina,
        speak English or Spanish, and have a 9-month-old child enrolled in Medicaid at the start of
        the study. Participants will be recruited in collaboration with the Children's Medical
        Practice (CMP) at Johns Hopkins Bayview Medical Center and matriculated on a rolling basis.
        Each participant will participate for approximately 15 months; the time required to complete
        the Time 1 assessment, either 10-week condition, and the two post-intervention assessments.
        The entire study is anticipated to be completed in 5 years. This RCT will test maternal
        sensitivity and child stress regulation as mediators of intervention effects. It will also
        examine the extent to which sociocultural factors moderate the effects of ABC. Behavioral
        methods and procedures will include surveys/questionnaires, audio/video recordings,
        individual or group behavioral observations, psychosocial or behavioral interventions, and
        other psychosocial or behavioral procedures. This RCT is powered to detect small-medium
        intervention effects (Cohen's d's= 0.35 - 0.50). These effect sizes align with previous
        studies, which have shown small to large effects on maternal sensitivity (d's = 0.23 - 0.77)
        and small to medium effects on main and moderated child behavioral stress regulation (d's=
        0.15 - 0.48) and child physiological (cortisol) regulation, via maternal sensitivity
        (d=-0.36). For .80 power or higher and a two-tailed significance level of .05, power analyses
        performed using Optimal Design, Webpower, and Gpower software indicated a post-attrition
        sample size of N=221 will adequately detect main, mediated, and moderated effects of
        comparable size. Analyses will be conducted in SAS 9.4, SPSS 25.0, and Mplus 8 and will
        include regression and structural equation models. Missing data will be accommodated using
        multiple imputations and/or full information maximum likelihood (FIML) and estimators that
        are robust to non-normality when missing data are present (e.g., MLR). Data safety monitoring
        will be conducted by the Principal Investigators and the external Data Safety and Monitoring
        Board, who will review adverse events, enrollment numbers, procedure reports, raw data,
        outcomes, preliminary analyses, and other data which will be completed on an ongoing basis
        and reported to the IRB and a sponsor. Study findings stand to inform the nature and timing
        of preventive interventions to reduce health disparities that disproportionately impact
        Latino families and will advance understanding of early social influences that promote health
        development across the lifespan.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A 2-group, pre-and post-test experimental design (N = 260; 130 in each group) will be employed. All eligible mother-child dyads will be randomly assigned to receive the intervention, Attachment Biobehavioral Catch- up (ABC),or the control, Home-Book-of-the- Week (HBOW). Assessments will take place in the participant's home and on the phone.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: 2 tasks will be coded by research assistants masked to assigned intervention condition.
  Child Stress Regulation: Using video-recorded data collected at Times 1 and 2, blinded coders will rate the child's emotion regulation strategies in the context of mild stressors. Coders will use the Laboratory Temperament Assessment Battery (Lab-TAB) to rate the presence/absence of the following behaviors every 5 seconds: looks to mother, communicative gestures, looks to environment; and self-stimulation. In keeping with our own and others' previous data reduction in this domain, we will compute two proportion-score composites for mother-oriented regulation and self-soothing regulation. Coders will rate children's emotional re-activity every 5 seconds to analyze emotional reactivity as a covariate.
  Sensitive Parenting Behaviors: At Times 1 and 2, blinded coders will collect observational assessments of sensitive parenting behaviors in 3 contexts: (a) play, (b) child distress, and (c) feeding.
  measure: Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
  time frame: This data will be gathered at Time 1 (9 months).
  description: This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
  measure: Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
  time frame: This data will be gathered at Time 2 (15 months).
  description: This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
  measure: Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
  time frame: This data will be gathered at Time 3 (24 months).
  description: This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
  measure: Rapid Weight Gain
  time frame: This data will be gathered at Time 1 (9 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Rapid Weight Gain
  time frame: This data will be gathered at Time 2 (15 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Rapid Weight Gain
  time frame: This data will be gathered at Time 3 (24 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Expressive Speech Delay
  time frame: This data will be gathered at Time 1 (9 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Expressive Speech Delay
  time frame: This data will be gathered at Time 2 (15 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Expressive Speech Delay
  time frame: This data will be gathered at Time 3 (24 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Other Pediatric Health Problem(s)
  time frame: This data will be gathered at Time 1 (9 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Other Pediatric Health Problem(s)
  time frame: This data will be gathered at Time 2 (15 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Other Pediatric Health Problem(s)
  time frame: This data will be gathered at Time 3 (24 months).
  description: This outcome will be assessed through a review of the children's Electronic Health Record.
  measure: Low Grade Inflammation
  time frame: This data will be gathered at Time 3 (24 months).
  description: This outcome will be assessed via markers of C-reactive protein (CRP) and interleukin-6 (IL-6) through a collection of blood spots using a traditional finger-prick. Blood spot collection is required at the 24-month pediatric well-child visit for all Baltimore City residents.
  measure: Body Mass Index
  time frame: This data will be gathered at Time 1 (9 months).
  description: This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
  measure: Body Mass Index
  time frame: This data will be gathered at Time 2 (15 months).
  description: This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
  measure: Body Mass Index
  time frame: This data will be gathered at Time 3 (24 months).
  description: This outcome will be collected through mothers reports about their children's current length and weight. In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
  measure: Sleep: Age 9 months
  time frame: Sleep data will be gathered at Time 1 (age 9 months).
  description: This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
  measure: Sleep: At 9 months
  time frame: Sleep data will be gathered at Time 1 (at 9 months).
  description: An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
  measure: Sleep: Age 15 months
  time frame: Sleep data will be gathered at Time 2 (age 15 months).
  description: This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
  measure: Sleep: At 15 months
  time frame: Sleep data will be gathered at Time 2 (at 15 months).
  description: An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
  measure: Sleep: Age 24 months
  time frame: Sleep data will be gathered at Time 3 (age 24 months).
  description: This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
  measure: Sleep: At 24 months
  time frame: Sleep data will be gathered at Time 3 (at 24 months).
  description: An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
  measure: Maternal Sensitivity during Semi-Structured Play
  time frame: This data will be collected at Time 1 (9 months).
  description: This outcome will be assessed with a 15-minute "Three Bag" interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
  measure: Maternal Sensitivity during Semi-Structured Play
  time frame: This data will be collected at Time 2 (15 months).
  description: This outcome will be assessed with a 15-minute "Three Bag" interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
  measure: Maternal Sensitivity to Child Distress
  time frame: This data will be collected at Time 1 (9 months).
  description: This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute "baseline" period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother "reunion" when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' "food to soothe" behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.
  measure: Maternal Sensitivity to Child Distress
  time frame: This data will be collected at Time 2 (15 months).
  description: This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute "baseline" period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother "reunion" when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' "food to soothe" behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.
  measure: Maternal Sensitivity during Feeding
  time frame: This data will be collected at Time 1 (9 months).
  description: This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
  measure: Maternal Sensitivity during Feeding
  time frame: This data will be collected at Time 2 (15 months).
  description: This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
  measure: Child Stress Regulation: Age 9 months
  time frame: This data will be collected at Time 1 (9 months).
  description: Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
  measure: Child Stress Regulation: Age 15 months
  time frame: This data will be collected at Time 2 (age 15 months).
  description: Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate.
  measure: Child Stress Regulation: At 15 months
  time frame: This data will be collected at Time 2 (at 15 months).
  description: The child's emotional dysregulation will be assessed by administrating mothers the Infant-Toddler Social and Emotional Assessment (ITSEA). The following three ITSEA subscales will be examined: internalizing, externalizing, and dysregulation. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
  arm group label: Attachment and Biobehavioral Catch-up (ABC) program
  arm group type: Experimental
  description: The ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic.
  arm group label: Home-Based Book-of-the-Week (HBOW) program
  arm group type: Active Comparator
  description: The HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being.
  intervention type: Behavioral
  intervention name: Attachment and Biobehavioral Catch-Up
  description: The ABC program consists of 10 one-hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Principal intervention activities include a discussion of basic attachment principles, guided practice of new parenting behaviors, and a review of video clips from previous sessions to help reinforce parenting targets. The parent coach promotes (a) nurturance, especially in response to distress; (b) following the child's lead with delight; and (c) avoiding frightening caregiving behavior. As specified by the ABC protocol, any/all other family members will be invited to observe or participate in each ABC session Each full-time ABC parent coach will serve 8 to 10 families at a time (i.e., complete 8-10 hourly ABC visits per week).
  arm group label: Attachment and Biobehavioral Catch-up (ABC) program
  other name: ABC
  intervention type: Other
  intervention name: Home-Based Book-of-the-Week
  description: The HBOW program is an active control condition developed by PI Berlin. It consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. During each of the 10 weeks, a trained RA will visit each HBOW mother to drop off the book and to ask briefly about the mother's and child's well-being (using a standard set of questions). Thus, this condition will parallel the intervention condition in duration (number of weeks) and structure, although it will be less intensive in terms of participant contact time per visit.
  arm group label: Home-Based Book-of-the-Week (HBOW) program
  other name: HBOW
  criteria: 
  gender: All
  minimum age: 8 Months
  maximum age: 12 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lisa Berlin, PhD
  role: Principal Investigator
  affiliation: University of Maryland
  last name: Natalie Slopen, PhD
  role: Study Chair
  affiliation: Harvard School of Public Health (HSPH)
  last name: Cathi Propper, PhD
  role: Study Chair
  affiliation: Department of Psychology and Neuroscience at UNC Chapel Hill
  last name: Lisa Berlin, PhD
  phone: 410.706.6392
  email: lberlin@ssw.umaryland.edu
  last name: Roderick Rose, PhD
  phone: 410.706.7023
  email: rrose@ssw.umaryland.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Dozier M, Bernard K. Coaching parents of vulnerable infants: The Attachment and Biobehavioral Catch-Up Approach. Guilford Press; 2019.
  citation: Berlin LJ, Martoccio TL, Jones Harden B. Improving early head start's impacts on parenting through attachment-based intervention: A randomized controlled trial. Dev Psychol. 2018 Dec;54(12):2316-2327. doi: 10.1037/dev0000592. Epub 2018 Oct 18.
  PMID: 30335427
  citation: Urquhart A, Clarke P. US racial/ethnic disparities in childhood asthma emergent health care use: National Health Interview Survey, 2013-2015. J Asthma. 2020 May;57(5):510-520. doi: 10.1080/02770903.2019.1590588. Epub 2019 Apr 8.
  PMID: 30958048
  citation: Kaar JL, Schmiege SJ, Kalkwarf HJ, Woo JG, Daniels SR, Simon SL. Longitudinal Assessment of Sleep Trajectories during Early Childhood and Their Association with Obesity. Child Obes. 2020 Apr;16(3):211-217. doi: 10.1089/chi.2019.0126. Epub 2019 Nov 21.
  PMID: 31750742
  citation: Berlin LJ, Martoccio TL, Bryce CI, Jones Harden B. Improving infants' stress-induced cortisol regulation through attachment-based intervention: A randomized controlled trial. Psychoneuroendocrinology. 2019 May;103:225-232. doi: 10.1016/j.psyneuen.2019.01.005. Epub 2019 Jan 4.
  PMID: 30716550
  citation: Cespedes EM, Rifas-Shiman SL, Redline S, Gillman MW, Pena MM, Taveras EM. Longitudinal associations of sleep curtailment with metabolic risk in mid-childhood. Obesity (Silver Spring). 2014 Dec;22(12):2586-92. doi: 10.1002/oby.20894. Epub 2014 Sep 19.
  PMID: 25234485
  citation: Dowd JB, Zajacova A, Aiello A. Early origins of health disparities: burden of infection, health, and socioeconomic status in U.S. children. Soc Sci Med. 2009 Feb;68(4):699-707. doi: 10.1016/j.socscimed.2008.12.010. Epub 2009 Jan 17.
  PMID: 19152993
  citation: Meltzer LJ, Pugliese CE. Sleep in young children with asthma and their parents. J Child Health Care. 2017 Sep;21(3):301-311. doi: 10.1177/1367493517712064. Epub 2017 Jun 5.
  PMID: 29119809
  citation: El-Sheikh M, Buckhalt JA, Granger DA, Erath SA, Acebo C. The association between children's sleep disruption and salivary interleukin-6. J Sleep Res. 2007 Jun;16(2):188-97. doi: 10.1111/j.1365-2869.2007.00593.x.
  PMID: 17542949
  citation: Hepworth AD, Berlin LJ, Salas K, Pardue-Kim M, Martoccio TL, Jones Harden B. Increasing maternal sensitivity to infant distress through attachment-based intervention: a randomized controlled trial. Attach Hum Dev. 2021 Dec;23(6):953-968. doi: 10.1080/14616734.2020.1834592. Epub 2020 Oct 27.
  PMID: 33108981
  citation: Worobey J, Lopez MI, Hoffman DJ. Maternal behavior and infant weight gain in the first year. J Nutr Educ Behav. 2009 May-Jun;41(3):169-75. doi: 10.1016/j.jneb.2008.06.005.
  PMID: 19411050
  citation: Hodges EA, Propper CB, Estrem H, Schultz MB. Feeding During Infancy: Interpersonal Behavior, Physiology, and Obesity Risk. Child Dev Perspect. 2020 Sep;14(3):185-191. doi: 10.1111/cdep.12376. Epub 2020 Jul 14.
  PMID: 34707686
  citation: Pachter LM, Coll CG. Racism and child health: a review of the literature and future directions. J Dev Behav Pediatr. 2009 Jun;30(3):255-63. doi: 10.1097/DBP.0b013e3181a7ed5a.
  PMID: 19525720
  citation: Williams DR, Lawrence JA, Davis BA. Racism and Health: Evidence and Needed Research. Annu Rev Public Health. 2019 Apr 1;40:105-125. doi: 10.1146/annurev-publhealth-040218-043750. Epub 2019 Feb 2.
  PMID: 30601726
  citation: Williams DR, Lawrence JA, Davis BA, Vu C. Understanding how discrimination can affect health. Health Serv Res. 2019 Dec;54 Suppl 2(Suppl 2):1374-1388. doi: 10.1111/1475-6773.13222. Epub 2019 Oct 29.
  PMID: 31663121
  citation: Coll CG, Magnuson K. Cultural Differences as Sources of Developmental. Handbook of early childhood intervention. 2000;
  citation: Garcia Coll C, Lamberty G, Jenkins R, McAdoo HP, Crnic K, Wasik BH, Vazquez Garcia H. An integrative model for the study of developmental competencies in minority children. Child Dev. 1996 Oct;67(5):1891-914.
  PMID: 9022222
  citation: Coll CG, Magnuson K. The psychological experience of immigration: A developmental perspective. Immigration and the family: Research and policy on US immigrants. 1997:91-131.
  citation: Hepworth AD, Berlin LJ, Martoccio TL, Jones Harden B. Maternal attachment style, sensitivity, and infant obesity risk in low-income, Latino families. Attach Hum Dev. 2021 Feb;23(1):75-89. doi: 10.1080/14616734.2020.1729214. Epub 2020 Mar 4.
  PMID: 32126901
  citation: Simons SM, Cillessen FH, Hazelzet JA. Determinants of a successful problem list to support the implementation of the problem-oriented medical record according to recent literature. BMC Med Inform Decis Mak. 2016 Aug 2;16:102. doi: 10.1186/s12911-016-0341-0.
  PMID: 27485127
  citation: McDade TW. Measuring immune function: markers of cell-mediated immunity and inflammation in dried blood spots. In: Ice GH, James GD, eds. Measuring Stress in Humans: A Practical Guide for the Field. Cambridge Univ Press; 2007:181-207. Cambridge Studies in Biological and Evolutionary Anthropology.
  citation: McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007 Nov;44(4):899-925. doi: 10.1353/dem.2007.0038.
  PMID: 18232218
  citation: Ohri-Vachaspati P, Acciai F, DeLia D, Lloyd K, Yedidia MJ. Accuracy of Parent-Measured and Parent-Estimated Heights and Weights in Determining Child Weight Status. JAMA Pediatr. 2019 Aug 1;173(8):793-795. doi: 10.1001/jamapediatrics.2019.1545.
  PMID: 31206143
  citation: Woo JG, Daniels SR. Assessment of Body Mass Index in Infancy: It Is Time to Revise Our Guidelines. J Pediatr. 2019 Jan;204:10-11. doi: 10.1016/j.jpeds.2018.09.025. Epub 2018 Oct 5. No abstract available.
  PMID: 30297288
  citation: Acebo C, Sadeh A, Seifer R, Tzischinsky O, Wolfson AR, Hafer A, Carskadon MA. Estimating sleep patterns with activity monitoring in children and adolescents: how many nights are necessary for reliable measures? Sleep. 1999 Feb 1;22(1):95-103. doi: 10.1093/sleep/22.1.95. Erratum In: Sleep 1999 Mar 15;22(2):143.
  PMID: 9989370
  citation: Buckhalt JA, El-Sheikh M, Keller P. Children's sleep and cognitive functioning: race and socioeconomic status as moderators of effects. Child Dev. 2007 Jan-Feb;78(1):213-31. doi: 10.1111/j.1467-8624.2007.00993.x.
  PMID: 17328701
  citation: Adams EL, Master L, Buxton OM, Savage JS. A longitudinal study of sleep-wake patterns during early infancy using proposed scoring guidelines for actigraphy. Sleep Med. 2019 Nov;63:98-105. doi: 10.1016/j.sleep.2019.05.017. Epub 2019 Jun 8.
  PMID: 31610384
  citation: Adams EL, Savage JS, Master L, Buxton OM. Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy. Sleep Med. 2020 Sep;73:238-245. doi: 10.1016/j.sleep.2020.07.003. Epub 2020 Jul 14.
  PMID: 32861189
  citation: Meltzer LJ, Mindell JA. Impact of a child's chronic illness on maternal sleep and daytime functioning. Arch Intern Med. 2006 Sep 18;166(16):1749-55. doi: 10.1001/archinte.166.16.1749.
  PMID: 16983054
  citation: Mindell JA, Gould RA, Tikotzky L, Leichman ES, Walters RM. Corrigendum to "Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R)" [Sleep Med 63 (2019) 106-114]. Sleep Med. 2020 Mar;67:286. doi: 10.1016/j.sleep.2019.12.012. Epub 2020 Feb 6. No abstract available.
  PMID: 32035744
  citation: Mills-Koonce WR, Cox M. Qualitative ratings for parent-child interaction at 3-48 months of age. (Unpublished coding scales). 2013;
  citation: Ursache A, Blair C, Granger DA, Stifter C, Voegtline K; Family Life Project Investigators. Behavioral reactivity to emotion challenge is associated with cortisol reactivity and regulation at 7, 15, and 24 months of age. Dev Psychobiol. 2014 Apr;56(3):474-88. doi: 10.1002/dev.21113. Epub 2013 Aug 5.
  PMID: 23918193
  citation: Leerkes EM, Nayena Blankson A, O'Brien M. Differential effects of maternal sensitivity to infant distress and nondistress on social-emotional functioning. Child Dev. 2009 May-Jun;80(3):762-75. doi: 10.1111/j.1467-8624.2009.01296.x.
  PMID: 19489902
  citation: Blair C, Ursache A, Mills-Koonce R, Stifter C, Voegtline K, Granger DA; Family Life Project Investigators. Emotional reactivity and parenting sensitivity interact to predict cortisol output in toddlers. Dev Psychol. 2015 Sep;51(9):1271-7. doi: 10.1037/dev0000031. Epub 2015 Jul 20.
  PMID: 26192038
  citation: Owen M. The NICHD study of early child care mother-infant interaction scales. Unpublished manuscript Dallas, TX: Timberlawn Psychiatric Research Foundation. 1992;
  citation: NICHD Early Child Care Research Network. Characteristics and quality of child care for toddlers and preschoolers. Applied Developmental Science. 2000;4(3):116-135.
  citation: Stifter CA, Moding KJ. Understanding and measuring parent use of food to soothe infant and toddler distress: A longitudinal study from 6 to 18 months of age. Appetite. 2015 Dec;95:188-96. doi: 10.1016/j.appet.2015.07.009. Epub 2015 Jul 9.
  PMID: 26164121
  citation: Goldsmith HH, Rothbart M. The laboratory temperament assessment battery (Locomotor Version 3.1). Madison, WI: University of Wisconsin-Madison. 1999;
  citation: Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.
  PMID: 14561058
  citation: Carter AS, Briggs-Gowan MJ. ITSEA: Infant-toddler social and emotional assessment examiner's manual. San Antonio, TX: PsychCorp. 2006;
  responsible party type: Principal Investigator
  investigator affiliation: University of Maryland, Baltimore
  investigator full name: Lisa Berlin
  investigator title: Professor
  mesh term: Digestive System Diseases
  mesh term: Gastrointestinal Diseases
  mesh term: Respiratory Tract Diseases
  mesh term: Respiration Disorders
  mesh term: Sleep Deprivation
  mesh term: Skin Diseases
  mesh term: Overweight
  mesh term: Inflammation
  sharing ipd: Yes
  ipd description: All collected IPD.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 3-5yrs after initial study publications.
  ipd access criteria: There will be only one master database in which participants' ID numbers and personal identifying information are linked. Only Dr. Berlin and the staff members who are directly involved in the data collection and processing will have access to this database. Electronic data will be stored on a secure network, with password protection such that only authorized users will have access to the file server. Any original data documents such as consent forms will be kept in locked compartments separate from identifying documentation. All electronic and paper files that contain identifying information will be destroyed at the conclusion of the research. Published data will not permit the identification of individuals