Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06338319
NA

Book Sharing for Toddlers With Clefts

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

20 Months - 32 Months

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2024-05-01

Completion Date

2028-08

Last Updated

2025-05-23

Healthy Volunteers

No

Interventions

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.

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States