Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638801
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Brain Uptrain to Improve Learning and Development
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Brain Uptrain to Improve Learning and Development A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUILD
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None