Book Sharing for Toddlers with Clefts (BOOST)

Seattle Children's Healthcare System

Status: Invitation-only

Conditions: Cleft Palate; Cleft Lip and Palate

Treatments: Behavioral: Book-Sharing for Toddlers with Clefts (BOOST)

Study type: Interventional

Funder types: Other

Identifiers

NCT06338319

23-048-E

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 24 to 32 months old

Volunteers: No Healthy Volunteers

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 24 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

BOOST Program

Experimental group

Description:

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

Treatment:

Behavioral: Book-Sharing for Toddlers with Clefts (BOOST)

Standard of Care Comparison Group

No Intervention group

Description:

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.