Clinical trial NCT02203617: Using Baby Books to Promote Maternal and Child Health
Official title: Using Baby Books to Promote Maternal and Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Condition 1 - Educational Condition (Educational Book Group)
Condition 2 - Non-educational Condition (Non-educational Book Group)
Condition 3 - Control Condition (No-book Group)
Keywords: anticipatory guidance
baby books
safety
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2014-07-30
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in knowledge of child development and parenting
timeFrame: Change from Baseline (pregnancy) to 18 months postpartum
measure: Change in Reading Practices
timeFrame: Change from 2 to 18 months postpartum
measure: Parenting Stress
timeFrame: Change from 2 to 18 months post-partum
measure: Costs
timeFrame: Cumulative costs over study duration
Secondary outcomes:
measure: Safety Practices
timeFrame: 2, 4, 6, 9, 12, and 18 months postpartum
measure: Attitudes about Corporal punishment
timeFrame: 2, 6, 12 and 18 months postpartum
measure: Maternal Depressive Symptoms
timeFrame: Change from baseline (pregnancy) to 18 months postpartum
measure: Beliefs about the Importance of Reading to Children
timeFrame: Change from baseline (prenatal) to 18 months postpartum
measure: Injuries and illnesses
timeFrame: 16 months (from 2 to 18 months postpartum)
measure: Quality of Parent-Child Interaction
timeFrame: Change from 2 to 18 months postpartum
measure: Home environment and parenting
timeFrame: Change from 2 to 18 months postpartum
measure: Receptive and Expressive language
timeFrame: Change from 6 to 18 months postpartum
measure: Cognitive and neurological development screening
timeFrame: 4, 6, 9 months postpartum
measure: Infant nutrition
timeFrame: 2, 4, 6, 9, 12, and 18 months postpartum
measure: Breastfeeding intentions and practices
timeFrame: prenatal and postnatal every visit until no longer breastfeeding
measure: Pregnancy uplifts and Hassles
timeFrame: Baselines (pregnancy)
measure: Parenting Satisfaction
timeFrame: Change from 2 to 18 months postpartum
measure: Parenting Self-Efficacy
timeFrame: Change from 2 to 18 months postpartum
measure: Reading self-efficacy
timeFrame: Change from 2 to 18 months postpartum
measure: Cognitive Development
timeFrame: 12 and 18 months postpartum
measure: Immunizations, medical visits, and growth status
timeFrame: 18 months postpartum
Other outcomes:
measure: Community Conditions
timeFrame: 4 months postpartum and following a move to a new residence
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University of California, Irvine
name: Stephanie M Reich, PhD
role: STUDY_DIRECTOR
affiliation: Vanderbilt University
name: Leonard Bickman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.