<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/NCT02203617</url>
  </required_header>
  <id_info>
    <org_study_id>R01HD447749</org_study_id>
    <nct_id>NCT02203617</nct_id>
  </id_info>
  <brief_title>Using Baby Books to Promote Maternal and Child Health</brief_title>
  <official_title>Using Baby Books to Promote Maternal and Child Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Baby Books Project tests whether embedding educational information into baby books can&#xD;
      improve the health and wellbeing of first-time mothers and their young children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study tests the efficacy of embedding educational information (i.e., pediatric&#xD;
      anticipatory guidance) into baby books that first-time mothers read to their infants. This&#xD;
      3-group longitudinal study recruited first-time mothers in their third trimester of&#xD;
      pregnancy, randomly assigned them to conditions, and followed them until the child was 18&#xD;
      months of age. One group received educational baby books, another group was given the same&#xD;
      illustrated books with non-educational text, and the third group was not given any books.&#xD;
      Thus, the effects of educational reading could be parsed from the effects of reading alone.&#xD;
      The study aimed to test whether embedding pediatric anticipatory guidance in picture books is&#xD;
      an effective method for increasing maternal knowledge of child development, parenting&#xD;
      strategies, and safety practices, improving parenting beliefs and attitudes (e.g., parenting&#xD;
      efficacy, importance of reading, use of corporal punishment), supporting optimal parenting&#xD;
      practices (e.g., breastfeeding and nutrition, responsiveness, safety practices), improving&#xD;
      maternal health (stress, depression), and supporting children's healthier development&#xD;
      (injuries, illness, immunizations, and linguistic, social, and cognitive development).&#xD;
&#xD;
      Survey and observational data collection occurred in participants' homes during their third&#xD;
      trimester of pregnancy and when their child was 2, 4, 6, 9, 12, and 18 months of age. Twelve&#xD;
      phone call interviews were conducted between these home visits. When children were 18 months,&#xD;
      a retrospective medical chart audit was conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2005</start_date>
  <completion_date type="Actual">July 2010</completion_date>
  <primary_completion_date type="Actual">June 2009</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge of child development and parenting</measure>
    <time_frame>Change from Baseline (pregnancy) to 18 months postpartum</time_frame>
    <description>Measured with Opinions about Babies questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Reading Practices</measure>
    <time_frame>Change from 2 to 18 months postpartum</time_frame>
    <description>Self-reported joint reading practices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting Stress</measure>
    <time_frame>Change from 2 to 18 months post-partum</time_frame>
    <description>Measured with the Parenting Stress Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Costs</measure>
    <time_frame>Cumulative costs over study duration</time_frame>
    <description>Maternal costs due to their own and their child's illness/injury, use of substances, and purchase of food was measured with the Incurred Cost Questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Practices</measure>
    <time_frame>2, 4, 6, 9, 12, and 18 months postpartum</time_frame>
    <description>Measured with the Home Safety Assessment, an observational and self-report measure of safety practices in the home, car, and outside</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes about Corporal punishment</measure>
    <time_frame>2, 6, 12 and 18 months postpartum</time_frame>
    <description>Adolescent-Adult Parenting Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Depressive Symptoms</measure>
    <time_frame>Change from baseline (pregnancy) to 18 months postpartum</time_frame>
    <description>Depressive symptoms were measured with the Center for Epidemiologic Studies Depression Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about the Importance of Reading to Children</measure>
    <time_frame>Change from baseline (prenatal) to 18 months postpartum</time_frame>
    <description>Maternal beliefs about the importance of reading was measured with the Modified Parent Reading Belief Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injuries and illnesses</measure>
    <time_frame>16 months (from 2 to 18 months postpartum)</time_frame>
    <description>Child illnesses injuries were measured with the Incurred Cost Questionnaire and through a retrospective medical chart audit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Parent-Child Interaction</measure>
    <time_frame>Change from 2 to 18 months postpartum</time_frame>
    <description>Video recording and in-vivo coding of mother-child dyads during play and reading.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home environment and parenting</measure>
    <time_frame>Change from 2 to 18 months postpartum</time_frame>
    <description>measured with the Home Observation for Measurement of Environment (HOME).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receptive and Expressive language</measure>
    <time_frame>Change from 6 to 18 months postpartum</time_frame>
    <description>Measured with the Preschool Language Scale - Fourth Edition (PLS4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive and neurological development screening</measure>
    <time_frame>4, 6, 9 months postpartum</time_frame>
    <description>Measured with the Bayley Infant Neurodevelopmental Screener (BINS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant nutrition</measure>
    <time_frame>2, 4, 6, 9, 12, and 18 months postpartum</time_frame>
    <description>Infant Nutrition Interview measured the introduction of news foods, types of foods, and serving portions at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding intentions and practices</measure>
    <time_frame>prenatal and postnatal every visit until no longer breastfeeding</time_frame>
    <description>measured with the Breastfeeding Intentions and Practices Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy uplifts and Hassles</measure>
    <time_frame>Baselines (pregnancy)</time_frame>
    <description>measured with the Pregnancy Experience Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Satisfaction</measure>
    <time_frame>Change from 2 to 18 months postpartum</time_frame>
    <description>measured with the Parenting Satisfaction Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Self-Efficacy</measure>
    <time_frame>Change from 2 to 18 months postpartum</time_frame>
    <description>Measured with the Maternal Self-Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reading self-efficacy</measure>
    <time_frame>Change from 2 to 18 months postpartum</time_frame>
    <description>measured with the Reading Self-Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Development</measure>
    <time_frame>12 and 18 months postpartum</time_frame>
    <description>measured with Exploratory Play Task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunizations, medical visits, and growth status</measure>
    <time_frame>18 months postpartum</time_frame>
    <description>measured through a retrospective medical chart audit.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Community Conditions</measure>
    <time_frame>4 months postpartum and following a move to a new residence</time_frame>
    <description>measured with the observational Community Conditions Checklist and self-report Community Conditions Interview</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Condition 1 - Educational Condition (Educational Book Group)</condition>
  <condition>Condition 2 - Non-educational Condition (Non-educational Book Group)</condition>
  <condition>Condition 3 - Control Condition (No-book Group)</condition>
  <arm_group>
    <arm_group_label>educational baby books</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>books embedded with educational information (pediatric anticipatory guidance)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-educational baby books</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>baby books given with same illustrations but no educational information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no books</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>not given any baby books</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Content/Pediatric Anticipatory Guidance</intervention_name>
    <description>educational information from Bright Futures Guidelines for Health Supervision for birth to 18 months</description>
    <arm_group_label>educational baby books</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Book provision</intervention_name>
    <description>Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum</description>
    <arm_group_label>educational baby books</arm_group_label>
    <arm_group_label>non-educational baby books</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant with first child and able to read in English at a first grade&#xD;
             reading level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with other children, men, those not able to read in English at a first grade&#xD;
             level&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie M Reich, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonard Bickman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Khalessi A, Reich SM. A Month of Breastfeeding Associated with Greater Adherence to Pediatric Nutrition Guidelines. J Reprod Infant Psychol. 2013 Jul 1;31(3):299-308. doi: 10.1080/02646838.2013.784898.</citation>
    <PMID>24062596</PMID>
  </reference>
  <results_reference>
    <citation>Reich SM, Penner EK, Duncan GJ, Auger A. Using baby books to change new mothers' attitudes about corporal punishment. Child Abuse Negl. 2012 Feb;36(2):108-17. doi: 10.1016/j.chiabu.2011.09.017. Epub 2012 Mar 3.</citation>
    <PMID>22391417</PMID>
  </results_reference>
  <results_reference>
    <citation>Reich SM, Penner EK, Duncan GJ. Using baby books to increase new mothers' safety practices. Acad Pediatr. 2011 Jan-Feb;11(1):34-43. doi: 10.1016/j.acap.2010.12.006.</citation>
    <PMID>21272822</PMID>
  </results_reference>
  <results_reference>
    <citation>Reich SM, Bickman L, Saville BR, Alvarez J. The effectiveness of baby books for providing pediatric anticipatory guidance to new mothers. Pediatrics. 2010 May;125(5):997-1002. doi: 10.1542/peds.2009-2728. Epub 2010 Apr 12.</citation>
    <PMID>20385630</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Leonard Bickman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>anticipatory guidance</keyword>
  <keyword>baby books</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02203617
org study id: R01HD447749
nct id: NCT02203617
lead sponsor: 
collaborator: 
has dmc: No
The Baby Books Project tests whether embedding educational information into baby books can
      improve the health and wellbeing of first-time mothers and their young children.
This study tests the efficacy of embedding educational information (i.e., pediatric
      anticipatory guidance) into baby books that first-time mothers read to their infants. This
      3-group longitudinal study recruited first-time mothers in their third trimester of
      pregnancy, randomly assigned them to conditions, and followed them until the child was 18
      months of age. One group received educational baby books, another group was given the same
      illustrated books with non-educational text, and the third group was not given any books.
      Thus, the effects of educational reading could be parsed from the effects of reading alone.
      The study aimed to test whether embedding pediatric anticipatory guidance in picture books is
      an effective method for increasing maternal knowledge of child development, parenting
      strategies, and safety practices, improving parenting beliefs and attitudes (e.g., parenting
      efficacy, importance of reading, use of corporal punishment), supporting optimal parenting
      practices (e.g., breastfeeding and nutrition, responsiveness, safety practices), improving
      maternal health (stress, depression), and supporting children's healthier development
      (injuries, illness, immunizations, and linguistic, social, and cognitive development).

      Survey and observational data collection occurred in participants' homes during their third
      trimester of pregnancy and when their child was 2, 4, 6, 9, 12, and 18 months of age. Twelve
      phone call interviews were conducted between these home visits. When children were 18 months,
      a retrospective medical chart audit was conducted.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
measure: Change in knowledge of child development and parenting
time frame: Change from Baseline (pregnancy) to 18 months postpartum
description: Measured with Opinions about Babies questionnaire
measure: Change in Reading Practices
time frame: Change from 2 to 18 months postpartum
description: Self-reported joint reading practices
measure: Parenting Stress
time frame: Change from 2 to 18 months post-partum
description: Measured with the Parenting Stress Index
measure: Costs
time frame: Cumulative costs over study duration
description: Maternal costs due to their own and their child's illness/injury, use of substances, and purchase of food was measured with the Incurred Cost Questionnaire.
measure: Safety Practices
time frame: 2, 4, 6, 9, 12, and 18 months postpartum
description: Measured with the Home Safety Assessment, an observational and self-report measure of safety practices in the home, car, and outside
measure: Attitudes about Corporal punishment
time frame: 2, 6, 12 and 18 months postpartum
description: Adolescent-Adult Parenting Inventory
measure: Maternal Depressive Symptoms
time frame: Change from baseline (pregnancy) to 18 months postpartum
description: Depressive symptoms were measured with the Center for Epidemiologic Studies Depression Scale.
measure: Beliefs about the Importance of Reading to Children
time frame: Change from baseline (prenatal) to 18 months postpartum
description: Maternal beliefs about the importance of reading was measured with the Modified Parent Reading Belief Inventory
measure: Injuries and illnesses
time frame: 16 months (from 2 to 18 months postpartum)
description: Child illnesses injuries were measured with the Incurred Cost Questionnaire and through a retrospective medical chart audit.
measure: Quality of Parent-Child Interaction
time frame: Change from 2 to 18 months postpartum
description: Video recording and in-vivo coding of mother-child dyads during play and reading.
measure: Home environment and parenting
time frame: Change from 2 to 18 months postpartum
description: measured with the Home Observation for Measurement of Environment (HOME).
measure: Receptive and Expressive language
time frame: Change from 6 to 18 months postpartum
description: Measured with the Preschool Language Scale - Fourth Edition (PLS4).
measure: Cognitive and neurological development screening
time frame: 4, 6, 9 months postpartum
description: Measured with the Bayley Infant Neurodevelopmental Screener (BINS)
measure: Infant nutrition
time frame: 2, 4, 6, 9, 12, and 18 months postpartum
description: Infant Nutrition Interview measured the introduction of news foods, types of foods, and serving portions at each time point.
measure: Breastfeeding intentions and practices
time frame: prenatal and postnatal every visit until no longer breastfeeding
description: measured with the Breastfeeding Intentions and Practices Scale
measure: Pregnancy uplifts and Hassles
time frame: Baselines (pregnancy)
description: measured with the Pregnancy Experience Scale
measure: Parenting Satisfaction
time frame: Change from 2 to 18 months postpartum
description: measured with the Parenting Satisfaction Scale
measure: Parenting Self-Efficacy
time frame: Change from 2 to 18 months postpartum
description: Measured with the Maternal Self-Efficacy Scale
measure: Reading self-efficacy
time frame: Change from 2 to 18 months postpartum
description: measured with the Reading Self-Efficacy Scale
measure: Cognitive Development
time frame: 12 and 18 months postpartum
description: measured with Exploratory Play Task
measure: Immunizations, medical visits, and growth status
time frame: 18 months postpartum
description: measured through a retrospective medical chart audit.
measure: Community Conditions
time frame: 4 months postpartum and following a move to a new residence
description: measured with the observational Community Conditions Checklist and self-report Community Conditions Interview
arm group label: educational baby books
arm group type: Experimental
description: books embedded with educational information (pediatric anticipatory guidance)
arm group label: non-educational baby books
arm group type: Active Comparator
description: baby books given with same illustrations but no educational information
arm group label: no books
arm group type: No Intervention
description: not given any baby books
intervention type: Behavioral
intervention name: Educational Content/Pediatric Anticipatory Guidance
description: educational information from Bright Futures Guidelines for Health Supervision for birth to 18 months
arm group label: educational baby books
intervention type: Behavioral
intervention name: Book provision
description: Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum
arm group label: educational baby books
arm group label: non-educational baby books
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephanie M Reich, PhD
role: Study Director
affiliation: University of California, Irvine
last name: Leonard Bickman, PhD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
facility: 
country: United States
citation: Khalessi A, Reich SM. A Month of Breastfeeding Associated with Greater Adherence to Pediatric Nutrition Guidelines. J Reprod Infant Psychol. 2013 Jul 1;31(3):299-308. doi: 10.1080/02646838.2013.784898.
PMID: 24062596
citation: Reich SM, Penner EK, Duncan GJ, Auger A. Using baby books to change new mothers' attitudes about corporal punishment. Child Abuse Negl. 2012 Feb;36(2):108-17. doi: 10.1016/j.chiabu.2011.09.017. Epub 2012 Mar 3.
PMID: 22391417
citation: Reich SM, Penner EK, Duncan GJ. Using baby books to increase new mothers' safety practices. Acad Pediatr. 2011 Jan-Feb;11(1):34-43. doi: 10.1016/j.acap.2010.12.006.
PMID: 21272822
citation: Reich SM, Bickman L, Saville BR, Alvarez J. The effectiveness of baby books for providing pediatric anticipatory guidance to new mothers. Pediatrics. 2010 May;125(5):997-1002. doi: 10.1542/peds.2009-2728. Epub 2010 Apr 12.
PMID: 20385630
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Leonard Bickman
investigator title: Professor
mesh term: Disease