Clinical trial NCT06338319: Book Sharing for Toddlers With Clefts
Official title: Book Sharing for Toddlers With Clefts
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cleft Palate
Cleft Lip and Palate
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Nationwide Children's Hospital
name: Children's Hospital Los Angeles
name: Ohio State University
First posted: 2024-03-29
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 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:

* 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

Primary outcomes:
measure: Expressive One Word Picture Vocabulary Test-Fourth Edition
timeFrame: End of study (At least 8 weeks after the end of the intervention period)
measure: Receptive One Word Picture Vocabulary Test-Fourth Edition
timeFrame: End of study (At least 8 weeks after the end of the intervention period)
measure: Child Language Sample
timeFrame: End of study (At least 8 weeks after the end of the intervention period)
measure: MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test
timeFrame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
Secondary outcomes:
measure: Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants
timeFrame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
Other outcomes:
measure: Frequency of Shared Reading
timeFrame: Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)
measure: Quality of Shared Reading
timeFrame: Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)
measure: Child Language During Reading
timeFrame: Throughout the intervention period of approximately 8 weeks and again at end of study (at least 8 weeks after the end of the intervention period)
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Brent Collett, PhD
role: PRINCIPAL_INVESTIGATOR
References: