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NCT Number: NCT06638801

Brain Uptrain to Improve Learning and Development

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.

Recruiting

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Key information

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

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

Primary outcomes

  1. ASQ-3 scores

    Time frame: 24 month well-child visit

    The total Ages and Stages Questionnaires 3rd Edition score at 24 months

Secondary outcomes

  1. ASQ-3 scores

    Time frame: 12 month well-child visit

    The total Ages and Stages Questionnaires 3rd Edition score at 12 months

  2. ASQ-3 scores

    Time frame: 36 month well-child visit

    The total Ages and Stages Questionnaires 3rd Edition score at 36 months

  3. ASQ scores below -2SD

    Time frame: 12 month well-child visit

    The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 12 months

  4. ASQ scores below -2SD

    Time frame: 24 month well-child visit

    The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 24 months

  5. ASQ scores below -2SD

    Time frame: 36 month well-child visit

    The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 36 months

  6. ASQ scores below -1SD

    Time frame: 12 month well-child visit

    The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 12 months

  7. ASQ scores below -1SD

    Time frame: 24 month well-child visit

    The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 24 months

  8. ASQ scores below -1SD

    Time frame: 36 month well-child visit

    The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 36 months

  9. Literacy Scores

    Time frame: 36 months

    Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 36 months

  10. Literacy Scores

    Time frame: 48 months

    Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition

  11. Literacy Scores

    Time frame: 60 months

    Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 60 months

  12. Kindergarten Readiness

    Time frame: 60 months

    Bracken School Readiness Assessment-Third Edition scores at 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Colm Travers

CONTACT

[email protected]

(205) 934-4680

Tamaryn Garcia

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial

Acronym: BUILD

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Oct 15, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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