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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
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
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Enrollment
188
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