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Book Sharing for Toddlers With Clefts — BOOST  

Cleft Lip and Palate Clinical Trial

Official title:
Book Sharing for Toddlers With Clefts

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06338319
Study type Interventional
Source Seattle Children's Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date April 16, 2024
Completion date August 2028
View Details
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