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

NCT06481072 | Recruiting

• 1 other identifier: Dnr 2023-05902-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Abdominal Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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).

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

Study Arms (2)

Intervention level 1 - patient education treatment.

EXPERIMENTAL

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

Other: Digital patient education

Intervention level 2 - patient education and iCBT

EXPERIMENTAL

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

Other: Digital patient education and iCBT

Interventions

Digital patient education OTHER

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.

Intervention level 1 - patient education treatment.

Digital patient education and iCBT OTHER

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.

Intervention level 2 - patient education and iCBT

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Gothenburg University

Gothenburg, Sweden

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Sandra Weineland, PhD

CONTACT

+46 708735788; sandra.weineland@vgregion.se, sandra.weineland@psy.gu.se

Emma Ramsay Milford, DEdPsy

CONTACT

+46708276061; emma.ramsay.milford@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 1, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1. IPD: * Available within 6 months after primary results publication or study completion. 2. Study Protocol: * Available upon request after trial results are published. 3. Statistical Analysis Plan: * Shared upon request post-primary manuscript publication. 4. Informed Consent Form: * De-identified ICF available upon request post-trial. 5. Clinical Study Report: * Available upon request post-results publication. 6. Analytic Code: * Shared upon request post-primary results publication for transparency. Conditions for Access: * Formal request and data sharing agreement required. * Agreement covers data use, privacy compliance, and ethical standards. * Researchers must submit a research plan and ethics approval. * PI reviews all requests for compliance.
• Access Criteria: 1. Research Proposal: Submit a proposal detailing objectives, methodology, impact, and specific IPD usage. 2. Ethics Approval: Provide evidence of ethics committee or IRB approval confirming ethical soundness. 3. Data Use Agreement: Sign a DUA outlining data access terms, including security, confidentiality, and usage limitations. 4. Data Security Measures: Demonstrate secure IPD handling, including encryption and access controls. 5. Researcher Qualifications: Provide academic and professional background to ensure research expertise. 6. Transparency and Accountability: Share results with the data provider before publication and acknowledge the data source. 7. Purpose Limitation: Use data solely for the specified research purpose. 8. Publication and Data Sharing: Commit to publishing findings in peer-reviewed journals and sharing results with the scientific community. 9. Compliance with Regulations: Comply with all applicable data protection laws, including GDPR if relevant.

Locations

SE (1)