Coach-led caregiver program to boost early learning and literacy
Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 1 Day to 7 Days |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06638801 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.