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Enrolling by invitation NCT06338319

Book Sharing for Toddlers With Clefts

No phase Interventional Cleft Palate Cleft Lip and Palate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Book-Sharing for Toddlers with Clefts (BOOST).
Who it may be relevant to
Registry conditions: Cleft Palate, Cleft Lip and Palate. Basic parameters: 20 months — 32 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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 upload

Primary outcome measures

  • Expressive One Word Picture Vocabulary Test-Fourth Edition [Time frame: End of study (At least 8 weeks after the end of the intervention period)]
  • Receptive One Word Picture Vocabulary Test-Fourth Edition [Time frame: End of study (At least 8 weeks after the end of the intervention period)]
  • Child Language Sample [Time frame: End of study (At least 8 weeks after the end of the intervention period)]
  • MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test [Time frame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)]
Secondary outcome measures (1)
  • Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants [Time frame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT06338319 · 23-048-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗