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

Official title

Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders Through a Collaborative Pathway Between Primary- and Specialist Pediatric Care: A Randomized Clinical Trial

Overview

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.

Detailed 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).

Interventions

• Other Digital patient education
  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
• Other Digital patient education and iCBT
  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

Primary outcome measures

• Change from baseline in pain related functional disability. [Time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion]
• Change from baseline in pain intensity. [Time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion.]
• Change from baseline in gastro symptom related worry. [Time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Gothenburg University — Gothenburg

Publications

• Cunningham NR, Nelson S, Jagpal A, Moorman E, Farrell M, Pentiuk S, Kashikar-Zuck S. Development of the Aim to Decrease Anxiety and Pain Treatment for Pediatric Functional Abdominal Pain Disorders. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):16-20. doi: 10.1097/MPG.0000000000001714. PMID 28906315
• Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004. PMID 15680928
• Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31. PMID 33130153
• Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9. PMID 16480823
• Lalouni M, Olen O, Bjureberg J, Bonnert M, Chalder T, Hedman-Lagerlof E, Reme SE, Serlachius E, Ljotsson B. Validation of child-adapted short scales for measuring gastrointestinal-specific avoidance and anxiety. Acta Paediatr. 2022 Aug;111(8):1621-1627. doi: 10.1111/apa.16403. Epub 2022 May 27. PMID 35545865

Identifiers

NCT: NCT06481072 · Dnr 2023-05902-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗