Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Coach-led caregiver-implemented early literacy and developmental programming
- Conditions
- Term Infant
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- ASQ-3 scores
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.
Detailed Description
This study will test the hypothesis that in term or late preterm infants who are discharged home from the newborn nursery, a coach-led caregiver-implemented early literacy and developmental program in addition to shared reading, compared with shared reading alone, will increase the Ages and Stages Questionnaire® score at 24 months. This will be a double blind randomized controlled trial with 1:1 parallel allocation using stratified permuted block design. Randomization will be stratified by gestational age (≥ 35 to \<38 weeks and ≥ 38 weeks). Randomization of twins and higher orders (when eligible) will be to the same group. Term and late preterm infants ≥ 35 weeks' gestation admitted to the newborn nursery are eligible for inclusion if they are being discharged home. We will exclude infants admitted to the NICU, infants with a known syndrome or major malformation, infants in DHR custody, infants enrolled in a competing study, and infants of families with a primary language other than English or Spanish. All study participants will receive shared reading information at scheduled well-child checks. Caregivers of infants in the intervention group will receive additional coach-led caregiver-implemented early literacy and developmental program. We will complete an ASQ-3 online or by telephone at 12 months, 24 months, and 36 months. We will also measure early literacy at 3 years, 4 years, and 5 years. The primary outcome will be the ASQ-3 scores at 24 months.
Investigators
Colm Travers
Associate Professor, Neonatologist
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •inborn at UAB, delivered at more than 35 weeks' gestation, planned for discharge home after initial hospitalization.
Exclusion Criteria
- •a major malformation, a known syndrome, admitted to the NICU, in DHR custody, enrolled in a competing study, and family's primary language is other than English or Spanish.
Arms & Interventions
Reach Out and Read plus intervention
Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program
Intervention: Coach-led caregiver-implemented early literacy and developmental programming
Reach Out and Read plus intervention
Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program
Intervention: Reach Out and Read Training
Reach out and Read only
Reach Out and Read at well child visits
Intervention: Reach Out and Read Training
Outcomes
Primary Outcomes
ASQ-3 scores
Time Frame: 24 month well-child visit
The total Ages and Stages Questionnaires 3rd Edition score at 24 months
Secondary Outcomes
- ASQ-3 scores(36 month well-child visit)
- ASQ scores below -2SD(36 month well-child visit)
- ASQ scores below -1SD(36 month well-child visit)
- Literacy Scores(60 months)
- Kindergarten Readiness(60 months)
- ASQ-3 scores(12 month well-child visit)
- ASQ scores below -2SD(12 month well-child visit)
- ASQ scores below -2SD(24 month well-child visit)
- ASQ scores below -1SD(12 month well-child visit)
- ASQ scores below -1SD(24 month well-child visit)
- Literacy Scores(36 months)
- Literacy Scores(48 months)