Brain Uptrain to Improve Learning and Development

NCT ID: NCT06638801

Last Updated: 2026-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-18
• Study Completion Date: 2031-06-18

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.

Conditions

Term Infant; Late Preterm Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Reach Out and Read plus intervention

Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program

Group Type: EXPERIMENTAL

Coach-led caregiver-implemented early literacy and developmental programming

Intervention Type: BEHAVIORAL

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.

Reach Out and Read Training

Intervention Type: BEHAVIORAL

Reach Out and Read parent training

Reach out and Read only

Reach Out and Read at well child visits

Group Type: ACTIVE_COMPARATOR

Reach Out and Read Training

Intervention Type: BEHAVIORAL

Reach Out and Read parent training

Interventions

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.

Intervention Type: BEHAVIORAL

Reach Out and Read Training

Reach Out and Read parent training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Colm Travers

Associate Professor, Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colm P Travers

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colm Travers

Role: CONTACT

cptravers@uabmc.edu

(205) 934-4680

Tamaryn Garcia

Role: CONTACT

thgarcia@uabmc.edu

Facility Contacts

Colm P Travers, MD

Role: primary

cptravers@uabmc.edu

2059344680

Jillian Hamilton, PhD

Role: backup

jchamilton@uabmc.edu

2059344680

Other Identifiers

IRB-300013307

Identifier Type: -

Identifier Source: org_study_id