ADAPTing CBT for Pediatric Functional Abdominal Pain in Spain

NCT07874867 | Not Yet Recruiting

• 1 other identifier: 64-2026-H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Many youth experience ongoing stomach pain that does not have a clear medical cause. These conditions, called functional abdominal pain disorders, are common and can last for years. They often interfere with school attendance, daily activities, and social life, and are frequently linked with anxiety. Families may go through many medical tests and appointments without finding relief. The investigators' research shows that teaching these children coping skills, such as relaxation, problem solving, and managing anxious thoughts, can reduce pain and improve functioning. The Aim to Decrease Anxiety and Pain Treatment (ADAPT) is a brief program developed by the investigators that uses cognitive behavioral strategies and mindfulness to help children manage pain and anxiety. However, access to providers trained to deliver these types of psychological treatments can be limited, creating a need for more accessible treatment options. The purpose of this project is to culturally adapt ADAPT for youth in Spain and deliver it through a digital platform, allowing children and families to access the program without requiring a trained provider to deliver each session. The project will evaluate how well the culturally adapted digital program works and whether it can be successfully delivered to youth in Spain. The goal is to increase access to evidence-based care, reduce pain and anxiety symptoms, and improve daily functioning for youth with functional abdominal pain disorders.

Conditions

Abdominal Pain

Keywords

functional abdominal pain disorders; pediatrics; cognitive behavioral; mindfulness; spain

Outcome Measures

Primary Outcomes (2)

• Retention Rates

  \>80% retention

  From Baseline to Post-assessment (8 weeks)

• Feasibility of intervention

  Responses to post assessment treatment perception questionnaire completed by both the child and the parent

  Post-assessment (Week 8)

Secondary Outcomes (17)

• Sociodemographic Characteristics

  Baseline (Week 0)

• Parental Chronic Pain and Perception of Child Pain

  Baseline (Week 0), Post-treatment (Week 8), and Follow-up (Week 12)

• Child Pain Intensity and Interference (BPI)

  Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)

• Child Pain-Related Functional Disability (FDI)

  Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)

• Child Fatigue (PROMIS Pediatric Fatigue Short Form)

  Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)

Study Arms (1)

ADAPT, cognitive behavioral program for pediatric functional abdominal pain

EXPERIMENTAL

Cognitive behavioral intervention for management of pediatric functional abdominal pain delivered via self-management platform

Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT)

Interventions

Aim to Decrease Anxiety and Pain Treatment (ADAPT) BEHAVIORAL

Cognitive behavioral intervention for management of pediatric functional abdominal pain, delivered via self-management platform

ADAPT, cognitive behavioral program for pediatric functional abdominal pain

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents aged 8-18 years with a clinical diagnosis of functional abdominal pain disorders (FAPD), established in pediatric care according to Rome IV criteria.
• Clinically significant functional disability, defined as a Functional Disability Inventory (FDI) score greater than 7.
• Sufficient Spanish language proficiency in both the child/adolescent and caregiver to complete the intervention and study assessments.

You may not qualify if:

• Major organic gastrointestinal disease (e.g., ulcerative colitis).
• Major psychiatric disorder requiring prioritized treatment (e.g., bipolar disorder or psychosis).
• Neurodevelopmental conditions requiring prioritized specialized treatment (e.g., autism spectrum disorder with substantial functional impairment).
• Inability to participate in a digital intervention due to lack of access or insurmountable technological barriers.

Sponsors & Collaborators

• Michigan State University: lead
• University of Malaga: collaborator

Study Sites (1)

Universidad de Málaga, UMA

Málaga, Spain

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Red Cedar Distinguished Professor, Associate Professor

Model Details: Cognitive behavioral intervention for management of pediatric functional abdominal pain digitized for youth in Spain

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)