Book Sharing for Toddlers with Clefts
(BOOST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help toddlers with an isolated cleft palate improve language and reading skills through a special book-sharing program called Book-Sharing for Toddlers with Clefts (BOOST). Parents will receive guidance on enhancing reading sessions with their children, and researchers will evaluate the impact on both child language skills and parent-child reading interactions. Eligible participants include children who have had palate repair surgery, are between 20 to 32 months old, and have access to a smartphone for recording reading sessions. As an unphased study, this trial offers a unique opportunity to contribute to valuable research that could enhance early childhood development strategies.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that this book-sharing intervention is safe for toddlers with clefts?
Research has shown that the Book-Sharing for Toddlers with Clefts (BOOST) program helps parents enhance their reading interactions with their children. The BOOST program is safe, involving simple, everyday activities. Parents and children participate in reading sessions together, a normal and safe activity. No problems have been reported from this type of program. The goal is to boost language skills through increased reading, which both parents and toddlers generally enjoy. The study is in the "Not Applicable" phase, indicating minimal risks as it focuses on behavior and interaction rather than medical treatment.12345
Why are researchers excited about this trial?
The BOOST program is unique because it focuses on enhancing parent-child interaction through book-sharing, a personalized approach not typically emphasized in standard cleft care. Unlike traditional treatments which primarily concentrate on surgical and speech therapy interventions, BOOST aims to foster cognitive and social development by involving parents in structured reading activities. Researchers are excited about this method because it could significantly improve the developmental outcomes for toddlers with clefts by leveraging everyday interactions, potentially offering a more holistic, family-centered treatment approach.
What evidence suggests that the BOOST program is effective for improving language and literacy in toddlers with clefts?
Research shows that children with cleft palates often experience language delays compared to those without. This trial tests the BOOST program, which involves parents in dialogic book-sharing, a special type of interactive reading. Studies suggest this method can enhance toddlers' language comprehension and usage. By increasing the quality and frequency of reading time between parents and children, the program aims to support language development effectively. Early findings indicate that children in the BOOST program may outperform those in the standard care comparison group in language skills.12346
Who Is on the Research Team?
Brent Collett, PhD
Principal Investigator
Seattle Children's Hospital
Are You a Good Fit for This Trial?
This trial is for toddlers aged 24 to 32 months with isolated cleft palate, who've had repair surgery over 6 months ago. It's for families speaking English or Spanish and able to record/send videos. Parents must consent and commit to the study duration.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Parents participate in a dialogic book-sharing intervention with their children, including 3 remote sessions for the BOOST Program group
Follow-up
Participants are monitored for changes in language and literacy outcomes after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Book-Sharing for Toddlers with Clefts (BOOST)
Trial Overview
The BOOST program aims to improve language skills in toddlers with clefts through a parent-led book-sharing intervention. The study will randomly assign participants and measure changes in children's language and parents' reading interactions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
Nationwide Children's Hospital
Collaborator
Children's Hospital Los Angeles
Collaborator
University of Washington
Collaborator
Ohio State University
Collaborator
Citations
Book-Sharing for Toddlers with Clefts (BOOST) - PubMed
First, toddlers randomized to BOOST will exhibit better language outcomes than children receiving standard-of-care (SOC). Second, we hypothesize ...
Book-Sharing for Toddlers with Clefts (BOOST)
Children with cleft palate, with or without cleft lip (CP±L), exhibit language delays on average compared to children without clefts.
NCT06338319 | Book Sharing for Toddlers With Clefts
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 ...
Book-Sharing for Toddlers with Clefts (BOOST)
Children with cleft palate, with or without cleft lip (CP±L), exhibit language delays on average compared to children without clefts.
Book Sharing for Toddlers With Clefts - ClinicalTrials.Veeva
This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will ...
Book Sharing for Toddlers with Clefts (BOOST Trial)
The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language.
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