An interventional study of Aim to Decrease Anxiety and Pain Treatment (ADAPT) in Abdominal Pain, sponsored by Michigan State University. Not yet recruiting at 1 site in Spain. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Michigan State University · Not applicable, Interventional, and Treatment
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.
344 studies on the registry are indexed under Abdominal Pain; 53 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 256 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Michigan State University is the lead sponsor of 141 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Cognitive behavioral intervention for management of pediatric functional abdominal pain delivered via self-management platform
Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT)
Cognitive behavioral intervention for management of pediatric functional abdominal pain, delivered via self-management platform
Retention Rates
\>80% retention
Time frame: 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
Time frame: Post-assessment (Week 8)
Sociodemographic Characteristics
Sociodemographic characteristics will be collected at baseline using study-specific questionnaires completed separately by adolescents and their caregivers. Information includes demographic characteristics, with caregivers also reporting residential postal code.
Time frame: Baseline (Week 0)
Parental Chronic Pain and Perception of Child Pain
Caregivers will complete a study-specific questionnaire assessing their own history of chronic pain and their perceptions of their child's pain.
Time frame: Baseline (Week 0), Post-treatment (Week 8), and Follow-up (Week 12)
Child Pain Intensity and Interference (BPI)
Adolescents will complete the Brief Pain Inventory (BPI) to assess pain intensity, pain-related interference with daily activities, and perceived treatment relief. The questionnaire includes numerical rating scales from 0 to 10, with higher pain intensity and interference scores indicating greater symptom burden.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Pain-Related Functional Disability (FDI)
Pain-related functional disability will be assessed using the Functional Disability Inventory (FDI), completed independently by adolescents and their caregivers using the child-report and parent-report versions, respectively. The FDI includes 13 items assessing difficulty performing everyday activities, with total scores ranging from 0 to 65. Higher scores indicate greater functional disability.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Fatigue (PROMIS Pediatric Fatigue Short Form)
Adolescents will complete the PROMIS Pediatric Fatigue Short Form to assess fatigue and its impact on daily functioning. The measure includes 10 items rated on a 5-point scale, with scores converted to standardized T-scores. Higher scores indicate greater fatigue.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Avoidant/Restrictive Food Intake Symptoms (NIAS)
Adolescents will complete the Nine Item ARFID Screen (NIAS), a 9-item self-report questionnaire assessing avoidant and restrictive eating behaviors, including food avoidance, fear of negative consequences of eating, and limited interest in food. Total scores range from 9 to 54, with higher scores indicating greater symptoms.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Social-Emotional Health (SEHS-S)
Adolescents will complete the Spanish-language Social Emotional Health Survey-Secondary (SEHS-S), a 36-item measure assessing social-emotional strengths across four domains: belief in self, belief in others, emotional competence, and engaged living. Total scores range from 36 to 144, with higher scores indicating greater social-emotional strengths.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Emotional Distress (SEDS-S)
Adolescents will complete the Social Emotional Distress Scale-Secondary (SEDS-S), a 10-item self-report measure assessing emotional distress, including internalizing symptoms such as anxiety, sadness, and school-related stress. Total scores range from 10 to 50, with higher scores indicating greater emotional distress.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Pain Medication Use
Caregivers will complete a study-specific questionnaire reporting medications taken by their child for pain management.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Healthcare Utilization for Child Chronic Pain
Caregivers will report the number of emergency department and primary care visits related to their child's chronic pain using a study-specific questionnaire.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Concomitant Treatments
Caregivers will report additional treatments received by their child outside of the ADAPT-ES intervention using a study-specific questionnaire.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Caregiver Emotional Functioning (DASS-21)
Caregivers will complete the Depression, Anxiety and Stress Scales-21 (DASS-21), a 21-item self-report questionnaire assessing symptoms of depression, anxiety, and stress. Each item is rated from 0 to 3, with higher scores indicating greater symptom severity.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Food Intake Frequency (FFQ)
Caregivers will complete the Food Frequency Questionnaire (FFQ) to report their child's usual frequency of consumption of various foods and food groups and characterize dietary intake patterns.
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Global Impression of Change Following Treatment (PGIC)
Children/adolescents and caregivers will each independently complete the Patient Global Impression of Change (PGIC) to assess perceived changes in the child's condition following treatment. The PGIC is a single-item measure rated on a 7-point scale ranging from much better to much worse.
Time frame: Post-assessment (Week 8) and Follow-up (Week 12)
Treatment Perceptions and Difficulty
Adolescents and caregivers will each independently complete treatment perception questions assessing their perceived helpfulness and difficulty of the ADAPT-ES digital intervention.
Time frame: Post-assessment (Week 8)
Application Evaluation
Adolescents and caregivers will each complete study-specific questions evaluating their experiences with the ADAPT-ES digital platform, including preferred features, suggestions for improvement, and overall impressions of the website.
Time frame: Post-assessment (Week 8)
Treatment-Related Adverse Events
Adolescents and caregivers will each report potential adverse experiences associated with ADAPT-ES, including increased worry about pain or feeling overwhelmed by treatment activities. Reported distress may be rated on a 4-point scale from 0 (not at all affected) to 3 (very negatively affected).
Time frame: Post-assessment (Week 8) and Follow-up (Week 12)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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