Late Preterm Infant, Term Infant
Conditions
Keywords
maternal training, cognitive scores, reading, literacy, numeracy
Brief summary
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
BEHAVIORALCoach-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.
BEHAVIORALReach Out and Read Training
Reach Out and Read parent training
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASQ-3 scores | 24 month well-child visit | The total Ages and Stages Questionnaires 3rd Edition score at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASQ-3 scores | 12 month well-child visit | The total Ages and Stages Questionnaires 3rd Edition score at 12 months |
| ASQ scores below -2SD | 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 |
| ASQ scores below -1SD | 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 |
| Literacy Scores | 36 months | Get Ready To Read- Revised, McArthur-Bates Communicative Development Inventory, Preschool Language Scales- Fifth Edition scores at 36 months |
| Kindergarten Readiness | 60 months | Bracken School Readiness Assessment-Third Edition scores at 60 months |
Countries
United States
Contacts
CONTACTColm Travers
CONTACTTamaryn Garcia
PRINCIPAL_INVESTIGATORColm P Travers
University of Alabama at Birmingham
Outcome results
None listed