An interventional study of Book-Sharing for Toddlers with Clefts (BOOST) in Cleft Palate and Cleft Lip and Palate, sponsored by Seattle Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 20 Months to 32 Months. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 320 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
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.
Time frame: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Plan to share: No
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