Brain Uptrain to Improve Learning and Development

Conditions

• Late Preterm Infant
• Term Infant

Eligibility Criteria

Sex

ALL

Age

1 Day - 7 Days

Healthy Volunteers

Not accepted

Interventions

• Coach-led caregiver-implemented early literacy and developmental programming — 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 — BEHAVIORAL
  Reach Out and Read parent training

Study Details

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.

Key Dates

Start date

Feb 18, 2026

Status verified

Jun 2025

Primary completion

Feb 18, 2029

Completion

Jun 18, 2031

Study Design

Enrollment

188 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

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

Primary Outcome Measure

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

Central Contacts

• Colm Travers
  (205) 934-4680
  [email protected]
• Tamaryn Garcia
  [email protected]

Locations (1)

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