NCT06638801

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
62mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Jun 2031

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2029

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2031

Last Updated

February 20, 2026

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

October 10, 2024

Last Update Submit

February 18, 2026

Conditions

Term InfantLate Preterm Infant

Keywords

maternal trainingcognitive scoresreadingliteracynumeracy

Outcome Measures

Primary Outcomes (1)

  • ASQ-3 scores

    The total Ages and Stages Questionnaires 3rd Edition score at 24 months

    24 month well-child visit

Secondary Outcomes (12)

  • ASQ-3 scores

    12 month well-child visit

  • ASQ-3 scores

    36 month well-child visit

  • ASQ scores below -2SD

    12 month well-child visit

  • ASQ scores below -2SD

    24 month well-child visit

  • ASQ scores below -2SD

    36 month well-child visit

  • +7 more secondary outcomes

Study Arms (2)

Reach Out and Read plus intervention

EXPERIMENTAL

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 programmingBehavioral: Reach Out and Read Training

Reach out and Read only

ACTIVE COMPARATOR

Reach Out and Read at well child visits

Behavioral: Reach Out and Read Training

Interventions

Coach-led caregiver-implemented early literacy and developmental programmingBEHAVIORAL

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 plus intervention
Reach Out and Read TrainingBEHAVIORAL

Reach Out and Read parent training

Reach Out and Read plus interventionReach out and Read only

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Colm P Travers

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colm Travers

CONTACT

(205) 934-4680cptravers@uabmc.edu

Tamaryn Garcia

CONTACT

thgarcia@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Neonatologist

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

February 18, 2026

Primary Completion (Estimated)

February 18, 2029

Study Completion (Estimated)

June 18, 2031

Last Updated

February 20, 2026

Record last verified: 2025-06

Locations

US(1)