- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203617
Using Baby Books to Promote Maternal and Child Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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Irvine, California, United States, 92697
- University of California, Irvine
-
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women who are pregnant with first child and able to read in English at a first grade reading level
Exclusion Criteria:
- Women with other children, men, those not able to read in English at a first grade level
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: educational baby books
books embedded with educational information (pediatric anticipatory guidance)
|
educational information from Bright Futures Guidelines for Health Supervision for birth to 18 months
Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum
|
Active Comparator: non-educational baby books
baby books given with same illustrations but no educational information
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Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum
|
No Intervention: no books
not given any baby books
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knowledge of child development and parenting
Time Frame: Change from Baseline (pregnancy) to 18 months postpartum
|
Measured with Opinions about Babies questionnaire
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Change from Baseline (pregnancy) to 18 months postpartum
|
Change in Reading Practices
Time Frame: Change from 2 to 18 months postpartum
|
Self-reported joint reading practices
|
Change from 2 to 18 months postpartum
|
Parenting Stress
Time Frame: Change from 2 to 18 months post-partum
|
Measured with the Parenting Stress Index
|
Change from 2 to 18 months post-partum
|
Costs
Time Frame: Cumulative costs over study duration
|
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.
|
Cumulative costs over study duration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Practices
Time Frame: 2, 4, 6, 9, 12, and 18 months postpartum
|
Measured with the Home Safety Assessment, an observational and self-report measure of safety practices in the home, car, and outside
|
2, 4, 6, 9, 12, and 18 months postpartum
|
Attitudes about Corporal punishment
Time Frame: 2, 6, 12 and 18 months postpartum
|
Adolescent-Adult Parenting Inventory
|
2, 6, 12 and 18 months postpartum
|
Maternal Depressive Symptoms
Time Frame: Change from baseline (pregnancy) to 18 months postpartum
|
Depressive symptoms were measured with the Center for Epidemiologic Studies Depression Scale.
|
Change from baseline (pregnancy) to 18 months postpartum
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Beliefs about the Importance of Reading to Children
Time Frame: Change from baseline (prenatal) to 18 months postpartum
|
Maternal beliefs about the importance of reading was measured with the Modified Parent Reading Belief Inventory
|
Change from baseline (prenatal) to 18 months postpartum
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Injuries and illnesses
Time Frame: 16 months (from 2 to 18 months postpartum)
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Child illnesses injuries were measured with the Incurred Cost Questionnaire and through a retrospective medical chart audit.
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16 months (from 2 to 18 months postpartum)
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Quality of Parent-Child Interaction
Time Frame: Change from 2 to 18 months postpartum
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Video recording and in-vivo coding of mother-child dyads during play and reading.
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Change from 2 to 18 months postpartum
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Home environment and parenting
Time Frame: Change from 2 to 18 months postpartum
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measured with the Home Observation for Measurement of Environment (HOME).
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Change from 2 to 18 months postpartum
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Receptive and Expressive language
Time Frame: Change from 6 to 18 months postpartum
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Measured with the Preschool Language Scale - Fourth Edition (PLS4).
|
Change from 6 to 18 months postpartum
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Cognitive and neurological development screening
Time Frame: 4, 6, 9 months postpartum
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Measured with the Bayley Infant Neurodevelopmental Screener (BINS)
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4, 6, 9 months postpartum
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Infant nutrition
Time Frame: 2, 4, 6, 9, 12, and 18 months postpartum
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Infant Nutrition Interview measured the introduction of news foods, types of foods, and serving portions at each time point.
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2, 4, 6, 9, 12, and 18 months postpartum
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Breastfeeding intentions and practices
Time Frame: prenatal and postnatal every visit until no longer breastfeeding
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measured with the Breastfeeding Intentions and Practices Scale
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prenatal and postnatal every visit until no longer breastfeeding
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Pregnancy uplifts and Hassles
Time Frame: Baselines (pregnancy)
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measured with the Pregnancy Experience Scale
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Baselines (pregnancy)
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Parenting Satisfaction
Time Frame: Change from 2 to 18 months postpartum
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measured with the Parenting Satisfaction Scale
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Change from 2 to 18 months postpartum
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Parenting Self-Efficacy
Time Frame: Change from 2 to 18 months postpartum
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Measured with the Maternal Self-Efficacy Scale
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Change from 2 to 18 months postpartum
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Reading self-efficacy
Time Frame: Change from 2 to 18 months postpartum
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measured with the Reading Self-Efficacy Scale
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Change from 2 to 18 months postpartum
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Cognitive Development
Time Frame: 12 and 18 months postpartum
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measured with Exploratory Play Task
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12 and 18 months postpartum
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Immunizations, medical visits, and growth status
Time Frame: 18 months postpartum
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measured through a retrospective medical chart audit.
|
18 months postpartum
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Community Conditions
Time Frame: 4 months postpartum and following a move to a new residence
|
measured with the observational Community Conditions Checklist and self-report Community Conditions Interview
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4 months postpartum and following a move to a new residence
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Stephanie M Reich, PhD, University of California, Irvine
- Principal Investigator: Leonard Bickman, PhD, Vanderbilt University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD447749
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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