Brain Uptrain to Improve Learning and Development (BUILD)

The University of Alabama at Birmingham

Status: Not yet enrolling

Conditions: Late Preterm Infant; Term Infant

Treatments: Behavioral: Coach-led caregiver-implemented early literacy and developmental programming; Behavioral: Reach Out and Read Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06638801

IRB-300013307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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188 participants in 2 patient groups

Reach Out and Read plus intervention

Experimental group

Description:

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

Treatment:

Behavioral: Reach Out and Read Training

Behavioral: Coach-led caregiver-implemented early literacy and developmental programming

Reach out and Read only

Active Comparator group

Description:

Reach Out and Read at well child visits

Treatment:

Behavioral: Reach Out and Read Training