UG3DE029753

Shared Reading Intervention for Children with Oral Clefts - Project Summary

Children with oral clefts are at increased risk for deficits in language and literacy compared to their peers. However, to date no attention has been given to interventions that might offset these risks.

This study will be the first to develop and test a shared reading intervention to promote language and emergent literacy for young children with oral clefts. We will tailor the intervention to the needs of this population, ensuring that the program can be delivered in coordination with regular craniofacial appointments and using innovative remote coaching strategies to facilitate engagement among families who have traditionally been under-represented in research (e.g., families living in rural areas).

Specifically, in-person sessions will be coordinated with children’s regular craniofacial care. Between visits, caregivers will use their smartphones to send video recordings of shared reading interactions for interventionists to review and provide encouragement and coaching.

The study will be conducted in craniofacial clinics at 3 major centers, which serve diverse and complementary patient populations: Seattle Children’s Hospital, Nationwide Children’s Hospital, and Children’s Hospital of Los Angeles. We will translate and review all materials for cultural and linguistic appropriateness for English and Spanish-speaking families.

In the planning phase (UG3) of the study, we will finalize our treatment and research protocols (Aim 1). We will recruit a sample of 30 children with oral clefts ages 16 to 20-months old and their caregivers for an abbreviated pilot test of the intervention. This will allow us to establish intervention feasibility/acceptability in our target population, and to establish treatment fidelity across centers (Aim 2). This pilot will also demonstrate whether the intervention engages proposed behavioral targets (i.e., parents’ reading behaviors) (Aim 3).

In the implementation phase (UH3), we will conduct a randomized controlled trial of the intervention with 320 children with oral clefts and their parents. We will enroll participants after palate repair (ages 16-20 months) and randomize half to receive the intervention and the other half to an information-only control group. The intervention will consist of 3 in-person sessions and 12 remote sessions delivered from baseline through age 36-months.

Aims for the RCT include:
(1) Test the hypothesis that intervention improves children’s language and literacy outcomes at age 36 months;
(2a) Test the hypothesis that intervention improves caregivers’ shared reading behaviors and (2b) that improvements in child outcomes are mediated by changes in caregivers’ shared reading behaviors; and
(3) Examine heterogeneity in outcomes based on demographic, clinical, and intervention characteristics.

This will be the first study to examine an intervention to address language and literacy deficits observed in children with oral clefts. In addition to improving care for children with oral clefts, the strategies used to extend the reach of intervention to rural and geographically diverse families will have implications for intervention delivery in many other child populations.

Seattle Children's Hospital

NOT APPLICABLE

93.121 - Oral Diseases and Disorders Research

National Institute of Dental and Craniofacial Research (NIDCR) [HHS - NIH]

Seattle, Washington 981212618 United States

Single Zip Code

NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) (PAR-18-656)

Amendment Since initial award the total obligations have increased 44% from $357,645 to $513,768.