Book Sharing for Toddlers With Clefts

Not Applicable

• Conditions: Cleft Lip and Palate; Cleft Palate
• Interventions: Behavioral: Book-Sharing for Toddlers with Clefts (BOOST)

• Registration Number: NCT06338319
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-03-29
• Study Start: 2024-05-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2028-06
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• A child's parent or primary caregiver provides a signed and dated informed consent form and permission for their child to participate.
• A child's parent is willing to comply with all study procedures and be available for the duration of the study.
• Child is between the ages of 20 to 32 months at the time of enrollment.
• Child has been diagnosed with isolated cleft palate, with or without cleft lip.
• Child has received palate repair surgery.
• The family's preferred language is English or Spanish.
• The family has access to a smartphone or similar device (e.g., tablets) capable of recording and sending videos.

Exclusion Criteria

• Diagnosed genetic condition associated with developmental delay (e.g., 22q11 deletion).
• The child has a diagnosis of autism spectrum disorder
• The child has a tracheostomy tube
• Child delivered < 32 weeks' gestation.
• Child in state custody or foster care.
• Child with significant sensory impairment (blindness, sensorineural hearing loss).
• The caregiver speaks a language other than English or Spanish
• The caregiver does not own a smartphone or similar device capable of recording/sending video

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BOOST Program	Book-Sharing for Toddlers with Clefts (BOOST)	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

Primary Outcome Measures

Name	Time	Method
Expressive One Word Picture Vocabulary Test-Fourth Edition	End of study (At least 8 weeks after the end of the intervention period)	Standardized, clinician-administered measure of expressive language. Possible raw scores range from 0 to 190, with higher scores indicating better expressive language
Child Language Sample	End of study (At least 8 weeks after the end of the intervention period)	Observational measure to assess child expressive language. We will obtain a count of the number of clear and intelligible utterances, the number of unique words used, and mean length of utterance. Higher scores indicate better child language skills.
MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test	Baseline and at end of study (at least 8 weeks after the end of the intervention period)	Parent report measure of children's expressive language. Raw scores range from 0 to 50, with higher scores indicating better expressive language.
Receptive One Word Picture Vocabulary Test-Fourth Edition	End of study (At least 8 weeks after the end of the intervention period)	Standardized, clinician-administered measure of receptive language. Raw scores range from 0 to 190, with higher scores indicating better receptive language.

Secondary Outcome Measures

Name	Time	Method
Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants	Baseline and at end of study (at least 8 weeks after the end of the intervention period)	Parent-administered measure to assess children's speech sound inventory and production accuracy. Children will be asked to name approximately 27 pictures. Responses will be recorded and phonetically transcribed to obtain a count of consonant sounds attempted and consonant sounds correct in the beginning, middle, and final positions for the pictured words. We will use these counts to obtain percent consonants correct - revised (#consonants correct/#consonants attempted). Higher scores indicate better speech sound accuracy. We will also count the total number of unique consonants produced, with higher scores indicating larger phonetic inventory.

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States