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.

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).

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.

1. Ethical and Legal Considerations:

   • Data will be anonymized per data protection laws to safeguard patient privacy.
   • Researchers must sign a data sharing agreement detailing data use, security measures, and confidentiality requirements.

2. Ethics Committee Approval:

   • Documentation of approval from a relevant ethics committee is required to ensure ethical soundness.

3. Scope and Responsibility:

   • Requesters must describe the intended data use and ensure data is not used for other purposes without consent.
   • Findings from data use must be shared with us before publication.

4. Security Measures:

   • Researchers must show that appropriate technical and organizational measures are in place for secure data handling and storage.

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.

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.