Book Sharing for Toddlers With Clefts

Cleft Lip and Palate Clinical Trial

— BOOST  

Official title:

Book Sharing for Toddlers With Clefts

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06338319
• Other study ID #: 23-048-E
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: August 2028

Study information

• Verified date: June 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 320
• Est. completion date: August 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 32 Months

Eligibility

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).

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Cleft Palate

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Children's Hospital Los Angeles, Nationwide Children's Hospital, Ohio State University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)