University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Location status: Recruiting
Location contact
Colm P Travers, MD
CONTACT
Jillian Hamilton, PhD
CONTACT
NCT Number: NCT06638801
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.
Interested in participating?
Request Info1 day–7 day
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
Location status: Recruiting
Colm P Travers, MD
CONTACT
Jillian Hamilton, PhD
CONTACT
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.
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.
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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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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 parent training
Time frame: 24 month well-child visit
The total Ages and Stages Questionnaires 3rd Edition score at 24 months
Time frame: 12 month well-child visit
The total Ages and Stages Questionnaires 3rd Edition score at 12 months
Time frame: 36 month well-child visit
The total Ages and Stages Questionnaires 3rd Edition score at 36 months
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
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
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
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
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
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
Time frame: 36 months
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 36 months
Time frame: 48 months
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition
Time frame: 60 months
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 60 months
Time frame: 60 months
Bracken School Readiness Assessment-Third Edition scores at 60 months
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
Acronym: BUILD
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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