Book Sharing for Toddlers with Clefts - Randomized Trial (BOOST RCT)
BOOST RCT
What is the goal of the study?
Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, we know little 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 used a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes of interest include child expressive and receptive vocabulary. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess potential mechanisms of action, we will test whether changes in child outcomes are mediated by changes in parents? behavior. We will explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups.
Who can participate in the study?
Pilot sample children will be eligible if they have a craniofacial diagnosis and they are ages 24 to 36 months. Study caregivers will be eligible if: the caregiver owns a smartphone capable of recording and sending video; English or Spanish is the primary language spoken in the home; the same caregiver is willing to participate in all intervention sessions; and the caregiver is age > 18-years and able to provide consent. RCT children will be eligible if they have isolated cleft palate only or cleft lip and palate; they have received palate repair surgery: they are ages 24-32 months.