NCT06338319

Book Sharing for Toddlers With Clefts

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 20 Months – 32 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft Palate
• Cleft Lip and Palate

Interventions

Type	Name	Description
BEHAVIORAL	Book-Sharing for Toddlers with Clefts (BOOST)	BOOST is a dialogic book-sharing intervention. Topics covered include strategies to increase the frequency of shared reading, child engagement and involvement in reading, and strategies to promote language development. Handouts will be shared during the sessions (using the Zoom share screen feature) and sent to families to summarize the content. Parents will record and securely upload shared reading videos during the intervention period. The research team will send prompts for these video uploads after each intervention session. Interventionists will review these videos between sessions to identify parent strengths, application of target skills, and opportunities for improvement.

Timeline

• Start date: 2024-05-01
• Primary completion: 2028-06-01
• Completion: 2028-08-01
• First posted: 2024-03-29
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States