Clinical trial NCT06638801: Brain Uptrain to Improve Learning and Development
Official title: Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Term Infant
Late Preterm Infant
Keywords: maternal training
cognitive scores
reading
literacy
numeracy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 188
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: ASQ-3 scores
timeFrame: 24 month well-child visit
Secondary outcomes:
measure: ASQ-3 scores
timeFrame: 12 month well-child visit
measure: ASQ-3 scores
timeFrame: 36 month well-child visit
measure: ASQ scores below -2SD
timeFrame: 12 month well-child visit
measure: ASQ scores below -2SD
timeFrame: 24 month well-child visit
measure: ASQ scores below -2SD
timeFrame: 36 month well-child visit
measure: ASQ scores below -1SD
timeFrame: 12 month well-child visit
measure: ASQ scores below -1SD
timeFrame: 24 month well-child visit
measure: ASQ scores below -1SD
timeFrame: 36 month well-child visit
measure: Literacy Scores
timeFrame: 36 months
measure: Literacy Scores
timeFrame: 48 months
measure: Literacy Scores
timeFrame: 60 months
measure: Kindergarten Readiness
timeFrame: 60 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers
role: PRINCIPAL_INVESTIGATOR
References: