Trials. 2024 Aug 19;25(1):549. doi: 10.1186/s13063-024-08371-8.

Rona L Levy ¹, Tasha B Murphy ², Miranda A L van Tilburg ^3 4 5, Margaret R Kuklinski ⁶, Jennifer A Bailey ⁶, Homer Aalfs ⁷, Isabel Badillo ⁷, Hafsah Diakhate ⁷, Tonya M Palermo ^7 8

Author information

¹School of Social Work, University of Washington, Seattle, WA, USA. rlevy@uw.edu.

²School of Social Work, University of Washington, Seattle, WA, USA.

³Cape Fear Valley Medical Center, Fayetteville, NC, USA.

⁴University of Washington, Seattle, WA, USA.

⁵Center for Functional GI & Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

⁶Social Development Research Group, University of Washington, Seattle, WA, USA.

⁷Center for Child Health, Behavior, & Development, Seattle Children's Research Institute, Seattle, WA, USA.

⁸Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, Seattle, WA, USA.

Abstract

Background: Chronic pain often clusters in families, where parents and their offspring both experience chronic pain conditions. Young children of parents with irritable bowel syndrome (IBS) represent an at-risk group for the development of abdominal pain, disability, and excess health care visits in later childhood. Parental solicitous responses to children's expressions of discomfort and maternal modeling of their own illness behavior contribute to a greater focus on somatic sensations, leading to illness behaviors in children. This randomized controlled trial will test the effectiveness of an early preventive web-based psychosocial intervention (REACH)[TM] vs. an educational web-based safety comparison condition delivered to parents with IBS to alter parental responses and lead to improved child health and decreased health care costs.

Methods: Parents with IBS who have children ages 4-7 years are recruited via community-based approaches (e.g., social media advertisements, school electronic distribution, research networks) and health care providers. The target sample is 460 parents randomized to REACH, a web-based social learning and cognitive behavior therapy (SLCBT) intervention or an educational web-based safety comparison condition (EC). Participants will be assessed at baseline, 6-week (immediate post-intervention), 6-month, 12-month, and 18-month follow-up periods (months post-completion of intervention). The primary outcome is change in parental solicitous/protective behaviors. Secondary outcomes include parent risk and protective factors, child health and symptom outcomes, and health care utilization and cost savings.

Discussion: This study adapts a validated, parent-delivered intervention to treat chronic pain in children to a web-based application designed to prevent the development of chronic pain in very young, high-risk children. If successful, this strategy can both prevent adverse sequelae of this condition from developing as well as be widely accessible. Furthermore, the availability of a prevention model for parent training could result in significant short- and long-term health benefits across a broad spectrum of conditions.

Trial registration: ClinicalTrials.gov NCT05730491. Registered on February 15, 2023.