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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorGöteborg University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Digital patient education

    Other intervention

    This educative intervention includes both medical and psychological explanations, as well as basic strategies to manage pediatric FAPD. The medical information spans the topics of pain, functional abdominal pain and general advice in terms of child health, and the psychological information is based on cognitive-behavioural and pain management theoretical approaches. The intervention consists of six short, animated films with a total run-time of approximately 30 minutes. The films each cover one of the following topics; Why and how do we feel pain? What is functional abdominal pain? How to help: general advice, Thoughts, feelings and behaviour, Goals and strategies. The films are accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform that is recognised by the care provider as meeting current safety criteria and standards.

  • Digital patient education and iCBT

    Other intervention

    This includes the educative intervention and a fully digital, four session version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), a CBT treatment program for FAPD. The treatment focuses on pain-management through the following core elements; The Pain-Gate Theory, breathing and relaxation strategies, calming statements, activity pacing, problem solving and behavior activation. This intervention is also accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Intervention level 1 - patient education treatment.Experimental treatment 1 intervention
Group B: Intervention level 2 - patient education and iCBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in pain related functional disability.

Functional disability is measured with the child report version of the Functional Disabilities Inventory (FDI). The FDI is a 15-item measure of difficulty in performing activities in the past several days, valid for youth with chronic pain, and is used in FAPD. Items are rated on a 5-point Likert scale, ranging from 0 to 4 ("No Trouble" to "Impossible") and summed to create a total score (range 0-60). Higher scores indicate greater disability.

Time frame
Within a week after intervention completion, 6 months after completion and 12 months after completion
2

Change from baseline in pain intensity.

Level of pain intensity will be obtained using a Visual Analogue Scale (VAS) 0-10. Higher scores indicate greater pain intensity.

Time frame
Within a week after intervention completion, 6 months after completion and 12 months after completion.
3

Change from baseline in gastro symptom related worry.

Child version of the Visceral Sensitivity Index (VSI-C) will be used to measure level of gastro-symptom related worry. The VSI-C is a 7-item rating scale, valid for children with functional abdominal pain disorders. Worry is rated 1-6 where higher scores indicate greater gastro-symptom related worry. Scores are summed to create a total score (range 0-42).

Time frame
Within a week after intervention completion, 6 months after completion and 12 months after completion

Secondary outcomes

Other outcomes

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