Clinical trial NCT06481072: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Abdominal Pain Syndrome
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Primary outcomes:
measure: Change from baseline in pain related functional disability.
timeFrame: Within a week after intervention completion, 6 months after completion and 12 months after completion
measure: Change from baseline in pain intensity.
timeFrame: Within a week after intervention completion, 6 months after completion and 12 months after completion.
measure: Change from baseline in gastro symptom related worry.
timeFrame: Within a week after intervention completion, 6 months after completion and 12 months after completion
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburg University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.