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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02203617
Other study ID # R01HD447749
Secondary ID
Status Completed
Phase N/A
First received July 18, 2014
Last updated April 13, 2017
Start date April 2005
Est. completion date July 2010

Study information

Verified date April 2017
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date July 2010
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Condition 1 - Educational Condition (Educational Book Group)
  • Condition 2 - Non-educational Condition (Non-educational Book Group)
  • Condition 3 - Control Condition (No-book Group)
  • Disease

Intervention

Behavioral:
Educational Content/Pediatric Anticipatory Guidance
educational information from Bright Futures Guidelines for Health Supervision for birth to 18 months
Book provision
Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum

Locations

Country Name City State
United States University of California, Irvine Irvine California
United States Vanderbilt University Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Community Conditions measured with the observational Community Conditions Checklist and self-report Community Conditions Interview 4 months postpartum and following a move to a new residence
Primary Change in knowledge of child development and parenting Measured with Opinions about Babies questionnaire Change from Baseline (pregnancy) to 18 months postpartum
Primary Change in Reading Practices Self-reported joint reading practices Change from 2 to 18 months postpartum
Primary Parenting Stress Measured with the Parenting Stress Index Change from 2 to 18 months post-partum
Primary Costs 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
Secondary Safety Practices 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
Secondary Attitudes about Corporal punishment Adolescent-Adult Parenting Inventory 2, 6, 12 and 18 months postpartum
Secondary Maternal Depressive Symptoms Depressive symptoms were measured with the Center for Epidemiologic Studies Depression Scale. Change from baseline (pregnancy) to 18 months postpartum
Secondary Beliefs about the Importance of Reading to Children Maternal beliefs about the importance of reading was measured with the Modified Parent Reading Belief Inventory Change from baseline (prenatal) to 18 months postpartum
Secondary Injuries and illnesses Child illnesses injuries were measured with the Incurred Cost Questionnaire and through a retrospective medical chart audit. 16 months (from 2 to 18 months postpartum)
Secondary Quality of Parent-Child Interaction Video recording and in-vivo coding of mother-child dyads during play and reading. Change from 2 to 18 months postpartum
Secondary Home environment and parenting measured with the Home Observation for Measurement of Environment (HOME). Change from 2 to 18 months postpartum
Secondary Receptive and Expressive language Measured with the Preschool Language Scale - Fourth Edition (PLS4). Change from 6 to 18 months postpartum
Secondary Cognitive and neurological development screening Measured with the Bayley Infant Neurodevelopmental Screener (BINS) 4, 6, 9 months postpartum
Secondary Infant nutrition Infant Nutrition Interview measured the introduction of news foods, types of foods, and serving portions at each time point. 2, 4, 6, 9, 12, and 18 months postpartum
Secondary Breastfeeding intentions and practices measured with the Breastfeeding Intentions and Practices Scale prenatal and postnatal every visit until no longer breastfeeding
Secondary Pregnancy uplifts and Hassles measured with the Pregnancy Experience Scale Baselines (pregnancy)
Secondary Parenting Satisfaction measured with the Parenting Satisfaction Scale Change from 2 to 18 months postpartum
Secondary Parenting Self-Efficacy Measured with the Maternal Self-Efficacy Scale Change from 2 to 18 months postpartum
Secondary Reading self-efficacy measured with the Reading Self-Efficacy Scale Change from 2 to 18 months postpartum
Secondary Cognitive Development measured with Exploratory Play Task 12 and 18 months postpartum
Secondary Immunizations, medical visits, and growth status measured through a retrospective medical chart audit. 18 months postpartum