Book Sharing for Toddlers With Clefts (BOOST)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cleft Lip and Palate; Cleft Palate
• Intervention / Treatment: Behavioral: Book-Sharing for Toddlers with Clefts (BOOST)

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brent Collett, PhD; Phone Number: 206-987-7572; Email: brent.collett@seattlechildrens.org
• Study Contact Backup: Name: Arushi Vyas, MA; Phone Number: 206-884-2574; Email: arushi.vyas@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 and is > 6 months post-surgery prior to enrollment.
• 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).
• Child delivered < 32 weeks' gestation.
• Child in state custody or foster care.
• Child with significant sensory impairment (blindness, sensorineural hearing loss).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOOST Program; 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	Behavioral: Book-Sharing for Toddlers with Clefts (BOOST); BOOST is a dialogic book-sharing intervention. Topics covered include strategies to increase the frequency of shared reading, child engagement and involvement in reading, and strategies to promote language development. Handouts will be shared during the sessions (using the Zoom share screen feature) and sent to families to summarize the content. Parents will record and securely upload shared reading videos during the intervention period. The research team will send prompts for these video uploads after each intervention session. Interventionists will review these videos between sessions to identify parent strengths, application of target skills, and opportunities for improvement.
No Intervention: Standard of Care Comparison Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expressive One Word Picture Vocabulary Test-Fourth Edition	Standardized, clinician-administered measure of expressive language. Possible raw scores range from 0 to 190, with higher scores indicating better expressive language	End of study (At least 8 weeks after the end of the intervention period)
Receptive One Word Picture Vocabulary Test-Fourth Edition	Standardized, clinician-administered measure of receptive language. Raw scores range from 0 to 190, with higher scores indicating better receptive language.	End of study (At least 8 weeks after the end of the intervention period)
Child Language Sample	Observational measure to assess child expressive language. We will obtain a count of the number of clear and intelligible utterances, the number of unique words used, and mean length of utterance. Higher scores indicate better child language skills.	End of study (At least 8 weeks after the end of the intervention period)
MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test	Parent report measure of children's expressive language. Raw scores range from 0 to 50, with higher scores indicating better expressive language.	Baseline and at end of study (at least 8 weeks after the end of the intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants	Parent-administered measure to assess children's speech sound inventory and production accuracy. Children will be asked to name approximately 27 pictures. Responses will be recorded and phonetically transcribed to obtain a count of consonant sounds attempted and consonant sounds correct in the beginning, middle, and final positions for the pictured words. We will use these counts to obtain percent consonants correct - revised (#consonants correct/#consonants attempted). Higher scores indicate better speech sound accuracy. We will also count the total number of unique consonants produced, with higher scores indicating larger phonetic inventory.	Baseline and at end of study (at least 8 weeks after the end of the intervention period)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Shared Reading	Parent report measure of shared reading, reported as the number of books read with their child in the last 24-hours. Higher scores indicate more frequent shared reading.	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)
Quality of Shared Reading	Observational measure of parent-child reading interactions, including a count of the dialogic book-sharing strategies used during the observation. Higher scores indicate higher quality shared reading interaction.	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)
Child Language During Reading	Observation of child language during reading interactions, including a count of the number of clear and intelligible utterances the child uses, the number of unique words, and the mean length of utterance. Higher scores will indicate better observed child language skills.	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)

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Washington; Ohio State University; Nationwide Children's Hospital; Children's Hospital Los Angeles
• Investigators: Principal Investigator: Brent Collett, PhD, Seattle Children's Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Cleft Lip
• Other Study ID Numbers: 23-048-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No