Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338319
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-11
First Post:
2024-03-22
Brief Title:
Book Sharing for Toddlers With Clefts
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Book Sharing for Toddlers With Clefts
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOOST
Brief Summary:
Children with clefts exhibit difficulty with language and literacy compared to children without clefts However little is known about interventions to address these difficulties in the cleft population This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate The study will use a randomized controlled trial RCT design and Intention to Treat ITT analyses Child outcomes include expressive and receptive language Parent outcomes of interest include the frequency and quality of shared reading interactions To assess mechanisms of action the study will test whether changes in child outcomes are mediated by changes in parents behavior Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None