Recruiting

Early Literacy Program

Sponsor:

University of Alabama at Birmingham

Code:

NCT06638801

Conditions

Term Infant

Late Preterm Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Coach-led caregiver-implemented early literacy and developmental programming

Reach Out and Read Training

Study Details

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.

Conditions

Term Infant

Late Preterm Infant

Study ID

NCT06638801

Start date

Feb 18, 2025

Status verified date

Jul, 2026

Completion date

Jun 18, 2031

Anticipated

Primary completion date

Feb 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Reach Out and Read plus intervention

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

active comparator: Reach out and Read only

Reach Out and Read at well child visits

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.

Reach Out and Read Training

Reach Out and Read parent training

Primary outcome measure

  • ASQ-3 scores [ Time Frame: 24 month well-child visit ]

Central Contacts and Locations

Central contacts

Colm Travers

(205) 934-4680cptravers@uabmc.edu

Tamaryn Garcia

thgarcia@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Colm P Travers, MD

2059344680cptravers@uabmc.edu

Jillian Hamilton, PhD

2059344680jchamilton@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • maternal training
  • cognitive scores
  • reading
  • literacy
  • numeracy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-16.