Book Sharing for Toddlers with Clefts

(BOOST Trial)

Overseen By Arushi Vyas, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Genetic condition, Autism, Tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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

The family has access to a smartphone or similar device (e.g., tablets) capable of recording and sending videos

My child had palate repair surgery more than 6 months ago.

A child's parent or primary caregiver provides a signed and dated informed consent form and permission for their child to participate

Exclusion Criteria

Child delivered < 32 weeks' gestation

Child in state custody or foster care

I have a genetic condition linked to developmental delays.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents participate in a dialogic book-sharing intervention with their children, including 3 remote sessions for the BOOST Program group

8 weeks

3 remote sessions

Follow-up

Participants are monitored for changes in language and literacy outcomes after the intervention

8 weeks

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?

Group I: BOOST Program Experimental Treatment 1 Intervention

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

Group II: Standard of Care Comparison Group Active Control 1 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.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38870107

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 ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0304630

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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06338319

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11175488/

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.

5. ctv.veeva.com ctv.veeva.com/study/book-sharing-for-toddlers-with-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 ...

6. withpower.com withpower.com/trial/phase-cleft-lip-3-2024-bf624

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.