Abdominal PainNCT07874867
ADAPTing CBT for Pediatric Functional Abdominal Pain in Spain
A study testing Aim to Decrease Anxiety and Pain Treatment (ADAPT) in people with Abdominal Pain, run by Michigan State University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Aim to Decrease Anxiety and Pain Treatment (ADAPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ADAPT: A Digital Self-Management Tool Adapted for Spanish Youth With Functional Abdominal Pain
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
- Being tested
- Aim to Decrease Anxiety and Pain Treatment (ADAPT)
- Keywords
- functional abdominal pain disorders, pediatrics, cognitive behavioral, mindfulness, spain
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim to Decrease Anxiety and Pain Treatment (ADAPT)Behavioural
Cognitive behavioral intervention for management of pediatric functional abdominal pain, delivered via self-management platform
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rates
>80% retention
Measured: 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
Measured: Post-assessment (Week 8)
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Post-assessment (Week 8) and Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cognitive behavioral intervention for management of pediatric functional abdominal pain digitized for youth in Spain
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874867
- Sponsor's protocol ID
- 64-2026-H
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPT: A Digital Self-Management Tool Adapted for Spanish Youth With Functional Abdominal Pain
- ClinicalTrials.gov ID
- NCT07874867
- Acronym / sponsor ID
- 64-2026-H
- Conditions
- Abdominal Pain
- Keywords
- functional abdominal pain disorders, pediatrics, cognitive behavioral, mindfulness, spain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cognitive behavioral intervention for management of pediatric functional abdominal pain digitized for youth in Spain
| Arm | Type | Receives |
|---|---|---|
| ADAPT, cognitive behavioral program for pediatric functional abdominal pain | Experimental | Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT)Cognitive behavioral intervention for management of pediatric functional abdominal pain delivered via self-management platform |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aim to Decrease Anxiety and Pain Treatment (ADAPT)Cognitive behavioral intervention for management of pediatric functional abdominal pain, delivered via self-management platform | Behavioural | ADAPT, cognitive behavioral program for pediatric functional abdominal pain |
Primary outcome
Retention Rates
Time frame: From Baseline to Post-assessment (8 weeks)
>80% retention
Feasibility of intervention
Time frame: Post-assessment (Week 8)
Responses to post assessment treatment perception questionnaire completed by both the child and the parent
17 secondary outcomes
Sociodemographic Characteristics
Time frame: Baseline (Week 0)
Parental Chronic Pain and Perception of Child Pain
Time frame: Baseline (Week 0), Post-treatment (Week 8), and Follow-up (Week 12)
Child Pain Intensity and Interference (BPI)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Pain-Related Functional Disability (FDI)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Fatigue (PROMIS Pediatric Fatigue Short Form)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Avoidant/Restrictive Food Intake Symptoms (NIAS)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Social-Emotional Health (SEHS-S)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Emotional Distress (SEDS-S)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Pain Medication Use
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Healthcare Utilization for Child Chronic Pain
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Concomitant Treatments
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Caregiver Emotional Functioning (DASS-21)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Child Food Intake Frequency (FFQ)
Time frame: Baseline (Week 0), Post-assessment (Week 8), and Follow-up (Week 12)
Global Impression of Change Following Treatment (PGIC)
Time frame: Post-assessment (Week 8) and Follow-up (Week 12)
Treatment Perceptions and Difficulty
Time frame: Post-assessment (Week 8)
Application Evaluation
Time frame: Post-assessment (Week 8)
Treatment-Related Adverse Events
Time frame: Post-assessment (Week 8) and Follow-up (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aim to Decrease Anxiety and Pain Treatment (ADAPT) in people with Abdominal Pain, run by Michigan State University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rates (time frame: From Baseline to Post-assessment (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.