Brain Uptrain to Improve Learning and Development

Purpose

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

Eligibility

Eligible Ages
Between 1 Day and 7 Days
Eligible Sex
All
Accepts Healthy Volunteers
No

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. -

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Reach Out and Read plus intervention 		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 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.
  • Behavioral: Reach Out and Read Training
    Reach Out and Read parent training
Active Comparator
Reach out and Read only 		Reach Out and Read at well child visits
  • Behavioral: Reach Out and Read Training
    Reach Out and Read parent training

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
Contact:
Colm P Travers, MD
2059344680
cptravers@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Colm Travers
(205) 934-4680
cptravers@uabmc.edu

Detailed Description

This study will test the hypothesis that in term or late preterm infants who are discharged home from the newborn nursery, a coach-led caregiver-implemented early literacy and developmental program in addition to shared reading, compared with shared reading alone, will increase the Ages and Stages Questionnaire® score at 24 months. This will be a double blind randomized controlled trial with 1:1 parallel allocation using stratified permuted block design. Randomization will be stratified by gestational age (≥ 35 to <38 weeks and ≥ 38 weeks). Randomization of twins and higher orders (when eligible) will be to the same group. Term and late preterm infants ≥ 35 weeks' gestation admitted to the newborn nursery are eligible for inclusion if they are being discharged home. We will exclude infants admitted to the NICU, infants with a known syndrome or major malformation, infants in DHR custody, infants enrolled in a competing study, and infants of families with a primary language other than English or Spanish. All study participants will receive shared reading information at scheduled well-child checks. Caregivers of infants in the intervention group will receive additional coach-led caregiver-implemented early literacy and developmental program. We will complete an ASQ-3 online or by telephone at 12 months, 24 months, and 36 months. We will also measure early literacy at 3 years, 4 years, and 5 years. The primary outcome will be the ASQ-3 scores at 24 months.