An interventional study of Coach-led caregiver-implemented early literacy and developmental programming and Reach Out and Read Training in Term Infant and Late Preterm Infant, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 1 Day to 7 Days. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
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.
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.
201 studies on the registry are indexed under Literacy; 69 are open to participants now.
This study's planned enrollment of 188 is above the median of 124 across 170 interventional studies indexed under Literacy.
Browse Literacy studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program
Behavioral: Coach-led caregiver-implemented early literacy and developmental programming · Behavioral: Reach Out and Read Training
Reach Out and Read at well child visits
Behavioral: Reach Out and Read Training
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
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 24 months
Time frame: 24 month well-child visit
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 12 months
Time frame: 12 month well-child visit
ASQ-3 scores
The total Ages and Stages Questionnaires 3rd Edition score at 36 months
Time frame: 36 month well-child visit
ASQ scores below -2SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 12 months
Time frame: 12 month well-child visit
ASQ scores below -2SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 24 months
Time frame: 24 month well-child visit
ASQ scores below -2SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition 2 standard deviations of more below the mean at 36 months
Time frame: 36 month well-child visit
ASQ scores below -1SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 12 months
Time frame: 12 month well-child visit
ASQ scores below -1SD
The proportion of children with Ages and Stages Questionnaires 3rd Edition one standard deviation of more below the mean at 24 months
Time frame: 24 month well-child visit
ASQ scores below -1SD
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 month well-child visit
Literacy Scores
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 36 months
Time frame: 36 months
Literacy Scores
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition
Time frame: 48 months
Literacy Scores
Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 60 months
Time frame: 60 months
Kindergarten Readiness
Bracken School Readiness Assessment-Third Edition scores at 60 months
Time frame: 60 months
Started Feb 2025 (actual). Primary completion is estimated for Feb 2029, 48 months after the start.
Of 115 non-industry interventional studies with no phase under Literacy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's planned 48 months is above that.
Counting every sponsor, half of 117 studies reached it within 11 months; a quarter within 4 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
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University of Alabama at Birmingham →