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

320 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Book-Sharing for Toddlers with Clefts (BOOST)?

The pilot study on enhanced milieu teaching with phonological emphasis (EMT+ PE) showed improvements in language and speech outcomes for toddlers with cleft lip and/or palate, suggesting that interventions focusing on communication can be beneficial for children with clefts. ^{1 2 3 4 5}

How does the BOOST treatment for toddlers with clefts differ from other treatments?

The BOOST treatment is unique because it focuses on book-sharing, which is an interactive activity that can support language development and parent-child bonding, rather than addressing physical growth or feeding challenges directly like other treatments for clefts. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Brent Collett, PhD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

I have a genetic condition linked to developmental delays.

Child in state custody or foster care

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Centre-level variation in speech outcome and interventions, and factors associated with poor speech outcomes in 5-year-old children with non-syndromic unilateral cleft lip and palate: The Cleft Care UK study. Part 4. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to the International Implementation of Standardized Outcome Measures in Clinical Cleft Practice. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Development of an Outcome Measure of Observable Signs of Health and Well-Being in Infants With Orofacial Clefts. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Effects of Enhanced Milieu Teaching With Phonological Emphasis on the Speech and Language Skills of Young Children With Cleft Palate: A Pilot Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Centre-level variation in treatment and outcomes and predictors of outcomes in 5-year-old children with non-syndromic unilateral cleft lip treated within a centralized service: the Cleft Care UK study. Part 6: summary and implications. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Parents' experiences of caring for a child with a cleft lip and/or palate: a review of the literature. [2011]

9. Singapore pubmed.ncbi.nlm.nih.gov

Evaluation of growth status of children with non-syndromic oral clefts. [2023]

10. Brazil pubmed.ncbi.nlm.nih.gov

Religious/spiritual coping in informal caregivers of children with cleft lip and/or dysphagic palate. [2021]