<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/NCT03808987</url>
  </required_header>
  <id_info>
    <org_study_id>1P50HD096698-01</org_study_id>
    <secondary_id>1P50HD096698-01</secondary_id>
    <nct_id>NCT03808987</nct_id>
  </id_info>
  <brief_title>Promotion of Successful Parenting</brief_title>
  <acronym>PROMISE</acronym>
  <official_title>TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</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>
      Home visitation by community health workers is a commonly utilized approach to support&#xD;
      families and prevent child maltreatment. At times, however, more intensive intervention is&#xD;
      needed to address familial trauma, depression, or other challenges. This preventive treatment&#xD;
      evaluation study evaluates whether adding Child-Parent Psychotherapy (CPP) to a Community&#xD;
      Health Worker (CHW) outreach model improves positive parenting and parent-child relationships&#xD;
      above CHW alone. The efficacy of CPP has been demonstrated with maltreated and other&#xD;
      high-risk populations. This evaluation will examine optimal timing of CPP (beginning&#xD;
      prenatally or postnatally) and optimal duration of services (6 vs. 12 months). Additionally,&#xD;
      how and for whom CPP is most effective and why will be examined. Assessments of parenting,&#xD;
      maternal sensitivity, representational models, cognitions, physiological reactivity, and&#xD;
      physical health indicators will be assessed prenatally, and at children's age of 3, 9, and 12&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PROMISE is integrated into the TRANSFORM Capstone Center to promote the next generation of&#xD;
      research on child maltreatment, translate research findings into clinical and preventive&#xD;
      interventions, and disseminate research and best practice to varied stakeholders. Informed by&#xD;
      developmental psychopathology, the research incorporates multiple levels of analysis within a&#xD;
      lifespan framework. Increasing knowledge of optimal methods for delivering dual mother and&#xD;
      child preventive intervention has crucial public health significance in preventing child&#xD;
      maltreatment. PROMISE involves a randomized control trial to evaluate whether expanding a&#xD;
      Community Health Worker (CHW) outreach model, by adding Child-Parent Psychotherapy (CPP), an&#xD;
      intensive intervention that focuses on parent-infant relationships for families at risk for&#xD;
      child maltreatment, increases efficacy for improved mother-child relationships, more&#xD;
      sensitive parenting, healthier child development, and maltreatment prevention. The efficacy&#xD;
      of CPP has been demonstrated with maltreated and other high-risk populations. Through the use&#xD;
      of four intervention arms, the evaluation will assess whether more intensive intervention&#xD;
      better protects against child maltreatment compared with CHW support alone, and will&#xD;
      determine the optimal timing of these interventions (i.e., beginning prenatally or&#xD;
      postnatally), the optimal duration of services (i.e., 6 vs. 12 months), mechanisms of effect&#xD;
      (mediator analyses), and which intervention strategy works best for mothers with varying risk&#xD;
      factors (moderator analyses). Pregnant women (N = 300) and their infants after birth will&#xD;
      participate. Longitudinal assessments will occur during the third trimester of pregnancy, at&#xD;
      infant's ages of 3 and 9 months, and a post-intervention follow-up at 15 months old. The&#xD;
      measurements obtained at each timepoint constitute a rich multi-level perspective of maternal&#xD;
      and child functioning over time in response to the interventions. Maternal parenting&#xD;
      behaviors, representational models, cognitions, and physiological reactivity, and infants'&#xD;
      health and development will be assessed longitudinally. CPP groups are hypothesized to&#xD;
      improve sensitive and responsive parenting and secure attachment, relative to CHW home&#xD;
      visitation alone, thereby reducing risks for child maltreatment. Improvements in maternal&#xD;
      attachment representations, parenting cognitions, and stress reactivity are hypothesized to&#xD;
      mediate treatment outcomes. Moderators, including maternal histories of trauma,&#xD;
      psychopathology, and intimate partner violence, will advance determination of differential&#xD;
      responsiveness to CHW and CPP (what works for whom and why?) and allow for tailored&#xD;
      preventive strategies. Identification of timing, dosage, and intensity of service delivery,&#xD;
      along with outcome mediators and moderators is innovative and will facilitate development of&#xD;
      targeted prevention and intervention strategies that support parenting and decrease child&#xD;
      maltreatment for this vulnerable population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2024</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>Child-Parent Psychotherapy</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research assistants will be blind to the arm the participant has been randomly assigned to and to study hypotheses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Parental Sensitivity (measured with the Parental Bonding Questionnaire)</measure>
    <time_frame>Assessment at child's age of 9 months</time_frame>
    <description>Improvements in maternal reports of positive emotional responses to their babies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)</measure>
    <time_frame>Assessment at child's age of 9 months</time_frame>
    <description>Improvements in maternal reports of acceptance in parent-child relationships</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental Sensitivity (measured with the Parental Bonding Questionnaire)</measure>
    <time_frame>Assessment at child's age of 15 months</time_frame>
    <description>Improvements in maternal reports of positive emotional responses to their babies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)</measure>
    <time_frame>Assessment at child's age of 15 months</time_frame>
    <description>Improvements in maternal reports of acceptance in parent-child relationships</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pregnant and Parenting Women</condition>
  <arm_group>
    <arm_group_label>CHW+CPP brief prenatal onset</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning prenatally, in addition to services from a Community Health Worker (CHW)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHW+CPP brief postnatal onset</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning postnatally, in addition to services from a Community Health Worker (CHW)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHW+CPP 12 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Child-Parent Psychotherapy (CPP) for 12 months, beginning prenatally, in addition to services from a Community Health Worker (CHW)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHW only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive services from a Community Health Worker (CHW) without Child-Parent Psychotherapy (CPP)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child-Parent Psychotherapy (CPP)</intervention_name>
    <description>Child-Parent Psychotherapy (CPP) focuses on parent-infant relationships, increases efficacy for improved mother-child relationships, more sensitive parenting, healthier child development, and maltreatment prevention. A primary goal is to strengthen the parent-child relationship to improve family functioning and child security of attachment. Through respect, empathic concern, and positive regard, the therapeutic relationship provides mothers with corrective emotional experiences, through which they are able to differentiate current from past relationships, form positive internal representations of themselves and of themselves in relationship to others, particularly their children. Parents are encouraged to process their experiences of trauma and restore parental roles as protective shields, improve affective regulation capacities, enhance understanding of the meaning of behavior, acknowledge the impact of trauma, and support children in a more positive developmental trajectory.</description>
    <arm_group_label>CHW+CPP 12 months</arm_group_label>
    <arm_group_label>CHW+CPP brief postnatal onset</arm_group_label>
    <arm_group_label>CHW+CPP brief prenatal onset</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Health Worker (CHW) home visitation</intervention_name>
    <description>Community Health Worker (CHW) home visitation includes assistance with concrete support needs, such as transportation to medical appointments, referrals for food, housing, and employment services, and attention to developmental needs of young children.</description>
    <arm_group_label>CHW only</arm_group_label>
    <arm_group_label>CHW+CPP 12 months</arm_group_label>
    <arm_group_label>CHW+CPP brief postnatal onset</arm_group_label>
    <arm_group_label>CHW+CPP brief prenatal onset</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be low-income pregnant adult women eligible for Medicaid and who&#xD;
             have been referred to a Community Health Worker program based on their high&#xD;
             psychosocial risk status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers will be excluded if they have significant cognitive limitations, severe&#xD;
             psychiatric disorders requiring a higher level of care (e.g., imminent suicidal&#xD;
             ideation requiring hospitalization, psychotic features), non-English proficiency, age&#xD;
             less than 18, or a physical disability that impedes ability to complete study&#xD;
             procedures. Mothers whose psychiatric needs or substance use requires inpatient&#xD;
             treatment will be excluded. Mothers will be excluded if they terminate their pregnancy&#xD;
             or do not deliver a live birth.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Enrollment will include pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mt. Hope Family Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Sheree Toth</investigator_full_name>
    <investigator_title>Director, Mt. Hope Family Center</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03808987
org study id: 1P50HD096698-01
secondary id: 1P50HD096698-01
nct id: NCT03808987
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Home visitation by community health workers is a commonly utilized approach to support
      families and prevent child maltreatment. At times, however, more intensive intervention is
      needed to address familial trauma, depression, or other challenges. This preventive treatment
      evaluation study evaluates whether adding Child-Parent Psychotherapy (CPP) to a Community
      Health Worker (CHW) outreach model improves positive parenting and parent-child relationships
      above CHW alone. The efficacy of CPP has been demonstrated with maltreated and other
      high-risk populations. This evaluation will examine optimal timing of CPP (beginning
      prenatally or postnatally) and optimal duration of services (6 vs. 12 months). Additionally,
      how and for whom CPP is most effective and why will be examined. Assessments of parenting,
      maternal sensitivity, representational models, cognitions, physiological reactivity, and
      physical health indicators will be assessed prenatally, and at children's age of 3, 9, and 12
      months.
PROMISE is integrated into the TRANSFORM Capstone Center to promote the next generation of
      research on child maltreatment, translate research findings into clinical and preventive
      interventions, and disseminate research and best practice to varied stakeholders. Informed by
      developmental psychopathology, the research incorporates multiple levels of analysis within a
      lifespan framework. Increasing knowledge of optimal methods for delivering dual mother and
      child preventive intervention has crucial public health significance in preventing child
      maltreatment. PROMISE involves a randomized control trial to evaluate whether expanding a
      Community Health Worker (CHW) outreach model, by adding Child-Parent Psychotherapy (CPP), an
      intensive intervention that focuses on parent-infant relationships for families at risk for
      child maltreatment, increases efficacy for improved mother-child relationships, more
      sensitive parenting, healthier child development, and maltreatment prevention. The efficacy
      of CPP has been demonstrated with maltreated and other high-risk populations. Through the use
      of four intervention arms, the evaluation will assess whether more intensive intervention
      better protects against child maltreatment compared with CHW support alone, and will
      determine the optimal timing of these interventions (i.e., beginning prenatally or
      postnatally), the optimal duration of services (i.e., 6 vs. 12 months), mechanisms of effect
      (mediator analyses), and which intervention strategy works best for mothers with varying risk
      factors (moderator analyses). Pregnant women (N = 300) and their infants after birth will
      participate. Longitudinal assessments will occur during the third trimester of pregnancy, at
      infant's ages of 3 and 9 months, and a post-intervention follow-up at 15 months old. The
      measurements obtained at each timepoint constitute a rich multi-level perspective of maternal
      and child functioning over time in response to the interventions. Maternal parenting
      behaviors, representational models, cognitions, and physiological reactivity, and infants'
      health and development will be assessed longitudinally. CPP groups are hypothesized to
      improve sensitive and responsive parenting and secure attachment, relative to CHW home
      visitation alone, thereby reducing risks for child maltreatment. Improvements in maternal
      attachment representations, parenting cognitions, and stress reactivity are hypothesized to
      mediate treatment outcomes. Moderators, including maternal histories of trauma,
      psychopathology, and intimate partner violence, will advance determination of differential
      responsiveness to CHW and CPP (what works for whom and why?) and allow for tailored
      preventive strategies. Identification of timing, dosage, and intensity of service delivery,
      along with outcome mediators and moderators is innovative and will facilitate development of
      targeted prevention and intervention strategies that support parenting and decrease child
      maltreatment for this vulnerable population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Child-Parent Psychotherapy
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Research assistants will be blind to the arm the participant has been randomly assigned to and to study hypotheses.
measure: Parental Sensitivity (measured with the Parental Bonding Questionnaire)
time frame: Assessment at child's age of 9 months
description: Improvements in maternal reports of positive emotional responses to their babies
measure: Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)
time frame: Assessment at child's age of 9 months
description: Improvements in maternal reports of acceptance in parent-child relationships
measure: Parental Sensitivity (measured with the Parental Bonding Questionnaire)
time frame: Assessment at child's age of 15 months
description: Improvements in maternal reports of positive emotional responses to their babies
measure: Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)
time frame: Assessment at child's age of 15 months
description: Improvements in maternal reports of acceptance in parent-child relationships
arm group label: CHW+CPP brief prenatal onset
arm group type: Experimental
description: Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning prenatally, in addition to services from a Community Health Worker (CHW)
arm group label: CHW+CPP brief postnatal onset
arm group type: Experimental
description: Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning postnatally, in addition to services from a Community Health Worker (CHW)
arm group label: CHW+CPP 12 months
arm group type: Experimental
description: Participants will receive Child-Parent Psychotherapy (CPP) for 12 months, beginning prenatally, in addition to services from a Community Health Worker (CHW)
arm group label: CHW only
arm group type: Experimental
description: Participants will receive services from a Community Health Worker (CHW) without Child-Parent Psychotherapy (CPP)
intervention type: Behavioral
intervention name: Child-Parent Psychotherapy (CPP)
description: Child-Parent Psychotherapy (CPP) focuses on parent-infant relationships, increases efficacy for improved mother-child relationships, more sensitive parenting, healthier child development, and maltreatment prevention. A primary goal is to strengthen the parent-child relationship to improve family functioning and child security of attachment. Through respect, empathic concern, and positive regard, the therapeutic relationship provides mothers with corrective emotional experiences, through which they are able to differentiate current from past relationships, form positive internal representations of themselves and of themselves in relationship to others, particularly their children. Parents are encouraged to process their experiences of trauma and restore parental roles as protective shields, improve affective regulation capacities, enhance understanding of the meaning of behavior, acknowledge the impact of trauma, and support children in a more positive developmental trajectory.
arm group label: CHW+CPP 12 months
arm group label: CHW+CPP brief postnatal onset
arm group label: CHW+CPP brief prenatal onset
intervention type: Behavioral
intervention name: Community Health Worker (CHW) home visitation
description: Community Health Worker (CHW) home visitation includes assistance with concrete support needs, such as transportation to medical appointments, referrals for food, housing, and employment services, and attention to developmental needs of young children.
arm group label: CHW only
arm group label: CHW+CPP 12 months
arm group label: CHW+CPP brief postnatal onset
arm group label: CHW+CPP brief prenatal onset
criteria: 
gender: Female
gender based: Yes
gender description: Enrollment will include pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Sheree Toth
investigator title: Director, Mt. Hope Family Center
sharing ipd: No