Book Sharing for Toddlers With Clefts

NCT06338319 | Enrolling By Invitation

• 1 other identifier: 23-048-E
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Palate; Cleft Lip and Palate

Outcome Measures

Primary Outcomes (4)

• Expressive One Word Picture Vocabulary Test-Fourth Edition

  Standardized, clinician-administered measure of expressive language. Possible raw scores range from 0 to 190, with higher scores indicating better expressive language

  End of study (At least 8 weeks after the end of the intervention period)

• Receptive One Word Picture Vocabulary Test-Fourth Edition

  Standardized, clinician-administered measure of receptive language. Raw scores range from 0 to 190, with higher scores indicating better receptive language.

  End of study (At least 8 weeks after the end of the intervention period)

• Child Language Sample

  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.

  End of study (At least 8 weeks after the end of the intervention period)

• MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test

  Parent report measure of children's expressive language. Raw scores range from 0 to 50, with higher scores indicating better expressive language.

  Baseline and at end of study (at least 8 weeks after the end of the intervention period)

Secondary Outcomes (1)

• 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)

Other Outcomes (3)

• Frequency of Shared Reading

  Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)

• Quality of Shared Reading

  Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)

• Child Language During Reading

  Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)

Study Arms (2)

BOOST Program

EXPERIMENTAL

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

Behavioral: Book-Sharing for Toddlers with Clefts (BOOST)

Standard of Care Comparison Group

NO INTERVENTION

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.

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.

BOOST Program

Eligibility Criteria

• Age: 20 Months - 32 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator
• Nationwide Children's Hospital: collaborator
• Children's Hospital Los Angeles: collaborator
• Ohio State University: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Study Officials

• Brent Collett, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)