Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
320 participants
INTERVENTIONAL
2024-05-01
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Months
32 Months
ALL
No
Sponsors
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University of Washington
OTHER
Nationwide Children's Hospital
OTHER
Children's Hospital Los Angeles
OTHER
Ohio State University
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Brent Collett, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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23-048-E
Identifier Type: -
Identifier Source: org_study_id
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