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Protocol for a randomized controlled trial of an internet-based prevention intervention for young children at-risk
Rona L Levy1, Tasha B Murphy2, Miranda A L van Tilburg3,4,5
1School of Social Work, University of Washington, Seattle, WA, USA. rlevy@uw.edu.
Insights
This study tests a web-based program to help parents of children with irritable bowel syndrome (IBS) reduce solicitous behaviors, aiming to prevent chronic pain in children. Early intervention can improve child health and lower healthcare costs.
Area of Science:
- Pediatric Health
- Gastroenterology
- Psychosocial Interventions
Background:
- Chronic pain frequently runs in families, with children of parents with irritable bowel syndrome (IBS) being at higher risk for developing abdominal pain and related issues.
- Parental responses, such as excessive solicitousness and illness behavior modeling, can exacerbate children's focus on somatic sensations and lead to illness behaviors.
- This research addresses the need for early, accessible interventions to mitigate the development of chronic pain in at-risk children.
Purpose of the Study:
- To evaluate the effectiveness of an early, preventive, web-based psychosocial intervention (REACH) compared to an educational control condition.
- To determine if the intervention can alter parental solicitous/protective behaviors in parents with IBS.
- To assess the impact on child health outcomes, parental risk factors, and healthcare utilization.
Main Methods:
- A randomized controlled trial involving 460 parents with IBS and children aged 4-7 years.
- Participants are randomized to either the REACH intervention (web-based social learning and cognitive behavior therapy) or an educational comparison condition.
- Data collection occurs at baseline and multiple follow-up points up to 18 months post-intervention, measuring parental behaviors, child health, and healthcare costs.
Main Results:
- Primary outcome is the change in parental solicitous/protective behaviors.
- Secondary outcomes include parent risk and protective factors, child health and symptom outcomes, and healthcare utilization and cost savings.
- The study is currently recruiting and results are pending.
Conclusions:
- This study adapts a validated intervention for chronic pain into a web-based format for early prevention in high-risk children.
- A successful web-based prevention model could be widely accessible and prevent adverse health outcomes.
- This approach holds potential for significant short- and long-term health benefits across various conditions.
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.
