Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care (FAPD)

Göteborg University

Status: Enrolling

Conditions: Functional Abdominal Pain Syndrome

Treatments: Other: Digital patient education and iCBT; Other: Digital patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT06481072

Dnr 2023-05902-01

Details and patient eligibility

About

The project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. The study will aim to find out if the treatments are effective and which children the different treatments are effective for.

Full description

The research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric FAPD where specialist level community-based pediatric clinics (CPC, Swedish Barn- och ungdomsmedicinsk mottagning) provide consultation and intervention to primary care health centers (HC). As children with FAPD benefit from early intervention, a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most. The model explores a collaboration whereby an initial diagnosis of FAPD will be made by a general practitioner at a participating HC, following which digital interventions with two levels, managed by CPC, will be provided. The aim of the study is to explore the effectiveness of the two levels in the stepped-care model, where level 1 involves digitally provided psychoeducation and enhanced information about FAPD, and level 2 is a digitally delivered cognitive behavior therapy (CBT) based psychological intervention for FAPD. The CBT intervention is a fully digital version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which has been developed into a Swedish language version through a project funded by the innovation fund in Region Vastragotaland (VGR).

Enrollment: 300 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible participants are children and young people aged 8-14.
• Diagnosed with functional abdominal pain disorders by their physician.
• Diagnosed at one of the participating primary care health centres.

Exclusion criteria

• Children and young people with scores above the clinical cut-off on the Revised Child Anxiety and Depression Scale (RCADS).
• Children who do not follow the mainstream Swedish National Curriculum due to learning disabilities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Intervention level 1 - patient education treatment.

Experimental group

Description:

Participants who are randomized to experimental condition arm 1 will be offered patient education for functional abdominal pain disorder (FAPD).

Treatment:

Other: Digital patient education

Intervention level 2 - patient education and iCBT

Experimental group

Description:

Participants who are randomized to experimental condition arm 2 will be offered patient education treatment and internet delivered cognitive behavior therapy (iCBT) treatment.

Treatment:

Other: Digital patient education and iCBT