Book Sharing for Toddlers With Clefts

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT06338319
Status
Enrolling By Invitation

Conditions

  • Cleft Lip and Palate
  • Cleft Palate

Eligibility Criteria

Sex
ALL
Age
20 Months - 32 Months
Healthy Volunteers
Not accepted

Interventions

  • Book-Sharing for Toddlers with Clefts (BOOST) — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
May 1, 2024
Status verified
May 2025
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BOOST Program
    Parents in the BOOST Program group will receive books to read with their children and send smartphone video recordings of their reading interactions. To provide support, parents will participate in 3 remote, parent-focused book-sharing intervention sessions
  • No Intervention: Standard of Care Comparison Group
    Parents in the Standard of Care Comparison Group will receive books to read with their children and send smartphone video recordings of their reading interactions. Parents in the comparison group will not participate in BOOST intervention sessions.

Primary Outcome Measure

Expressive One Word Picture Vocabulary Test-Fourth Edition [ Time Frame: End of study (At least 8 weeks after the end of the intervention period) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98101-

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