[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06338319":3,"trial-entities:NCT06338319":94,"trial-summary:NCT06338319":16},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":50,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":14,"eligibility_criteria":57,"std_ages":76,"locations":78,"central_contacts":87,"overall_officials":88,"references":92,"see_also_links":93},"NCT06338319","23-048-E","Book Sharing for Toddlers With Clefts","ENROLLING_BY_INVITATION","2028-08","2025-05","2025-05-23","2024-05-01","Seattle Children's Hospital","OTHER",false,"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.",null,[18,19],"Cleft Palate","Cleft Lip and Palate",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},320,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"BOOST Program",[36,40,43,46],{"measure":37,"description":38,"timeFrame":39},"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)",{"measure":41,"description":42,"timeFrame":39},"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.",{"measure":44,"description":45,"timeFrame":39},"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.",{"measure":47,"description":48,"timeFrame":49},"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)",[51],{"measure":52,"description":53,"timeFrame":49},"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\u002F#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.","ALL","20 Months","32 Months",{"inclusion":58,"exclusion":66,"raw_text":75},[59,60,61,62,63,64,65],"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 20 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.","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.",[67,68,69,70,71,72,73,74],"Diagnosed genetic condition associated with developmental delay (e.g., 22q11 deletion).","The child has a diagnosis of autism spectrum disorder","The child has a tracheostomy tube","Child delivered \\\u003C 32 weeks' gestation.","Child in state custody or foster care.","Child with significant sensory impairment (blindness, sensorineural hearing loss).","The caregiver speaks a language other than English or Spanish","The caregiver does not own a smartphone or similar device capable of recording\u002Fsending video","Inclusion Criteria:\n\n* A child's parent or primary caregiver provides a signed and dated informed consent form and permission for their child to participate.\n* A child's parent is willing to comply with all study procedures and be available for the duration of the study.\n* Child is between the ages of 20 to 32 months at the time of enrollment.\n* Child has been diagnosed with isolated cleft palate, with or without cleft lip.\n* Child has received palate repair surgery.\n* The family's preferred language is English or Spanish.\n* The family has access to a smartphone or similar device (e.g., tablets) capable of recording and sending videos.\n\nExclusion Criteria:\n\n* Diagnosed genetic condition associated with developmental delay (e.g., 22q11 deletion).\n* The child has a diagnosis of autism spectrum disorder\n* The child has a tracheostomy tube\n* Child delivered \\\u003C 32 weeks' gestation.\n* Child in state custody or foster care.\n* Child with significant sensory impairment (blindness, sensorineural hearing loss).\n* The caregiver speaks a language other than English or Spanish\n* The caregiver does not own a smartphone or similar device capable of recording\u002Fsending video",[77],"CHILD",[79],{"facility":12,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Seattle","Washington","98101","United States",{"lat":85,"lon":86},47.60621,-122.33207,[],[89],{"name":90,"affiliation":12,"role":91},"Brent Collett, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[18,96],"Cleft palate with cleft lip",[]]