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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Nationwide Children's Hospital | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Ohio State University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOOST Program | Experimental | 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 |
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| Standard of Care Comparison Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Book-Sharing for Toddlers with Clefts (BOOST) | Behavioral | 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. |
| 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) |
| 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. |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brent Collett, PhD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| OTHER |
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| Baseline and 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) |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008047 | Lip Diseases |