Book-Sharing for Toddlers with Clefts (BOOST): Protocol for a randomized controlled trial of a remote intervention to promote language development in children with cleft palate.

BACKGROUND: Children with cleft palate, with or without cleft lip (CP±L), exhibit language delays on average compared to children without clefts. Interventions to address these disparities are scarce. In this multi-center study, Book Sharing for Toddlers with Clefts (BOOST), we will test a remote, parent-focused intervention to promote language development in children with CP±L. OBJECTIVES: The study will test two primary hypotheses. First, toddlers randomized to BOOST will exhibit better language outcomes than children receiving standard-of-care (SOC). Second, we hypothesize that the BOOST program's effect on language outcomes is mediated by the frequency and quality of parent-child reading interactions. METHODS: The study is a randomized-controlled trial comparing the BOOST group to a SOC comparison group. We will enroll N = 320 English and/or Spanish-speaking children ages 24-32 months with isolated CP±L (n = 160 per group). Both groups will receive children's books, and parents will record and upload videos of themselves reading the books with their children using a smartphone app developed for the study. Parents will also complete surveys asking whether they read to their children on five randomly selected days each week. In addition, the BOOST group will participate in 3 remote dialogic book-sharing intervention sessions via Zoom. We will code book-sharing videos to assess parents' target skill usage and children's expressive language. End-of-study assessments will include measures of child language outcomes (e.g., clinician-administered measures, parent reports, and naturalistic child language samples). RESULTS: Enrollment began in April 2024 and will continue through approximately April 2028. CONCLUSION: The BOOST study will address a critical gap in the literature on interventions to improve language in children with CP±L. The results will inform the care for toddlers with oral clefts and have potential applications for other populations.

The games they play: Observations of children with autism spectrum disorder on the school playground.

The playground may be an important context to examine the social functioning of children with autism spectrum disorder. Previous literature on playground peer engagement has used quantitative methods, but there is limited research using qualitative observations to understand the nuances of playground behavior. Using a mixed-methods approach, 55 elementary school-aged children with autism spectrum disorder who are primarily included in general education settings were observed on the school playground using the Playground Observation of Peer Engagement. Quantitative and qualitative data were examined using a mixed-methods approach. The results showed that children with autism spectrum disorder: engage in solitary and peripheral activities; demonstrate appropriate initiations and responses to peers; display self-stimulatory, motoric behaviors most frequently during solitary activities; and often have neutral affect on the playground. These findings suggest that intervention and supports for children with autism spectrum disorder may be important to deliver at recess to address peer engagement.