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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.
Age
1 - 2 years
Sex
ALL
Healthy Volunteers
No
Seattle Children's Hospital
Seattle, Washington, United States
Start Date
May 1, 2024
Primary Completion Date
June 1, 2028
Completion Date
August 1, 2028
Last Updated
May 23, 2025
320
ESTIMATED participants
Book-Sharing for Toddlers with Clefts (BOOST)
BEHAVIORAL
Lead Sponsor
Seattle Children's Hospital
Collaborators
NCT06683560
NCT07048418
NCT06505330
Data Source & Attribution
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