Brain Uptrain to Improve Learning and Development (BUILD)

Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Late Preterm Infant; Term Infant
• Intervention / Treatment: Behavioral: Coach-led caregiver-implemented early literacy and developmental programming; Behavioral: Reach Out and Read Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colm Travers; Phone Number: (205) 934-4680; Email: cptravers@uabmc.edu
• Study Contact Backup: Name: Tamaryn Garcia; Email: thgarcia@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Jillian Hamilton, PhD; Phone Number: 2059344680; Email: jchamilton@uabmc.edu
      • Contact: Colm P Travers, MD; Phone Number: 2059344680; Email: cptravers@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: inborn at UAB, delivered at more than 35 weeks' gestation, planned for discharge home after initial hospitalization.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reach Out and Read plus intervention; Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program	Behavioral: Coach-led caregiver-implemented early literacy and developmental programming; Caregivers will receive training about child brain development in the first 3 years of life. The training will emphasize the areas of spoken words, physical education, pointer-finger concept, focus and label, reading lessons, and mathematics.; Behavioral: Reach Out and Read Training; Reach Out and Read parent training
Active Comparator: Reach out and Read only; Reach Out and Read at well child visits	Behavioral: Reach Out and Read Training; Reach Out and Read parent training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASQ-3 scores	The total Ages and Stages Questionnaires 3rd Edition score at 24 months	24 month well-child visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASQ-3 scores	The total Ages and Stages Questionnaires 3rd Edition score at 12 months	12 month well-child visit
ASQ-3 scores	The total Ages and Stages Questionnaires 3rd Edition score at 36 months	36 month well-child visit
ASQ scores below -2SD	The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 12 months	12 month well-child visit
ASQ scores below -2SD	The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 24 months	24 month well-child visit
ASQ scores below -2SD	The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 36 months	36 month well-child visit
ASQ scores below -1SD	The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 12 months	12 month well-child visit
ASQ scores below -1SD	The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 24 months	24 month well-child visit
ASQ scores below -1SD	The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 36 months	36 month well-child visit
Literacy Scores	Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 36 months	36 months
Literacy Scores	Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition	48 months
Literacy Scores	Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 60 months	60 months
Kindergarten Readiness	Bracken School Readiness Assessment-Third Edition scores at 60 months	60 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Colm P Travers, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): February 18, 2029
• Study Completion (Estimated): June 18, 2031

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: literacy; numeracy; reading; maternal training; cognitive scores
• Additional Relevant MeSH Terms: Behavior; Communication; Literacy
• Other Study ID Numbers: IRB-300013307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No