Cleft Lip and Palate Clinical Trial
— BOOSTOfficial title:
Book Sharing for Toddlers With Clefts
Verified date | June 2024 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Children's Hospital Los Angeles, Nationwide Children's Hospital, Ohio State University, University of Washington |
United States,
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) |
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