Brain Uptrain to Improve Learning and Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coach-led caregiver-implemented early literacy and developmental programming, Reach Out and Read Training.
- Who it may be relevant to
- Registry conditions: Term Infant, Late Preterm Infant. Basic parameters: 1 Day — 7 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- ASQ-3 scores [Time frame: 24 month well-child visit]
Secondary outcome measures (12)
- ASQ-3 scores [Time frame: 12 month well-child visit]
- ASQ-3 scores [Time frame: 36 month well-child visit]
- ASQ scores below -2SD [Time frame: 12 month well-child visit]
- ASQ scores below -2SD [Time frame: 24 month well-child visit]
- ASQ scores below -2SD [Time frame: 36 month well-child visit]
- ASQ scores below -1SD [Time frame: 12 month well-child visit]
- ASQ scores below -1SD [Time frame: 24 month well-child visit]
- ASQ scores below -1SD [Time frame: 36 month well-child visit]
- Literacy Scores [Time frame: 36 months]
- Literacy Scores [Time frame: 48 months]
- Literacy Scores [Time frame: 60 months]
- Kindergarten Readiness [Time frame: 60 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06638801 · IRB-300013307 · UAB