Coach-led caregiver program to boost early learning and literacy
Official title: Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
Run by University of Alabama at Birmingham · NCT06638801 · Data updated 2026-11-12
This program will test whether adding coach-led caregiver training in early literacy and numeracy to regular shared reading helps term and late preterm infants have better developmental scores at 24 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 7 Days |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | February 18, 2025 |
| Main results expected | February 18, 2029 |
| Study ends | June 18, 2031 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT06638801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants born at University of Alabama at Birmingham at ≥35 weeks' gestation who are being discharged home with caregivers who speak English or Spanish and do not have major malformations or known syndromes.
✕Probably not a fit
Infants admitted to the NICU, those with major malformations or known syndromes, those in DHR custody, families whose primary language is neither English nor Spanish, or those already in a competing study are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blind, randomized 1:1 trial comparing shared reading alone to shared reading plus a coach-led, caregiver-implemented early literacy and numeracy program for infants born at or after 35 weeks. Randomization is stratified by gestational age and twins are randomized together. Caregivers receive Reach Out and Read training and intervention-group caregivers receive additional coaching; outcomes include ASQ-3 developmental scores at 12, 24, and 36 months and early literacy measures at ages 3–5 years. The primary outcome is the ASQ-3 score at 24 months, with data collected from parent surveys, medical records, and standardized assessments.
Why it matters
Potential benefit: If successful, the program could improve early developmental scores and early literacy/numeracy skills, supporting better school readiness.
How similar studies have gone: Related programs like Reach Out and Read have shown benefits for early language and literacy, but the addition of coach-led caregiver-implemented numeracy training in a randomized, double-blind design is less extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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. \-
Where it's running
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University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting
Study contacts
- Principal investigator: Colm P Travers — University of Alabama at Birmingham
- Study coordinator: Colm Travers
- Email: cptravers@uabmc.edu
- Phone: (205) 934-4680
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.