Your session is about to expire
← Back to Search
Behavioral Intervention
ADAPT for Abdominal Pain, Functional Abdominal Pain Syndrome, and Anxiety
N/A
Waitlist Available
Led By Natoshia Cunningham, PhD
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 9 weeks
Awards & highlights
Study Summary
This trial is testing a promising non-drug treatment for a common and disabling problem in children, which current treatments don't help.
Who is the study for?
This trial is for children aged 11-16 with functional abdominal pain and significant anxiety, who can speak English well enough to follow the study protocol. They must not be in current therapy for pain or anxiety, have no metal implants that affect MRI scans, no brain injuries, serious medical conditions with organic causes of abdominal pain, severe sensory impairments, developmental disorders like autism or psychosis, severe depression or suicidal thoughts.Check my eligibility
What is being tested?
The ADAPT program is being tested as a non-drug treatment for kids with complex functional abdominal pain and anxiety. The study will use fMRI scans to understand how this treatment affects brain function in hopes of improving future therapies.See study design
What are the potential side effects?
Since ADAPT is a nonpharmacological intervention focusing on psychological therapy rather than medication, it may not have typical drug side effects. However, participants might experience discomfort from the fMRI procedure or emotional distress during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Connectivity of Amygdala with the Prefrontal Cortex
Secondary outcome measures
Adverse Childhood Events (ACEs)
Affective Reactivity Index- Parent- Report
Affective Reactivity Index- Self Report
+26 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ADAPTExperimental Treatment1 Intervention
Participants randomized to ADAPT will complete Aim to Decrease Anxiety and Pain Treatment (ADAPT), a remotely delivered tailored intervention that integrates mindfulness meditation with cognitive behavioral therapy. It consists of 6 sessions and blends pain and anxiety coping strategies. The first 2 sessions are interactive with a trained psychological provider and the following 4 sessions are web-based. Each web-based session is followed by therapist support.
Group II: Waitlist ControlActive Control1 Intervention
Participants randomized to waitlist control will receive medical treatment as usual. These participants will be given the opportunity to complete ADAPT upon completion of the post assessment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADAPT
2015
N/A
~530
Find a Location
Who is running the clinical trial?
Spectrum Health HospitalsOTHER
64 Previous Clinical Trials
553,160 Total Patients Enrolled
1 Trials studying Functional Abdominal Pain Syndrome
Michigan State UniversityLead Sponsor
184 Previous Clinical Trials
601,358 Total Patients Enrolled
2 Trials studying Functional Abdominal Pain Syndrome
139 Patients Enrolled for Functional Abdominal Pain Syndrome
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,884 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving therapy for pain or anxiety.You have a medical device like a cochlear implant, pacemaker, or neurostimulator with electrical parts. You also have metal in your body that could cause problems during an fMRI scan.You have a brain injury caused by a physical problem, like trauma or disease.Children with serious medical conditions that have a known physical cause, including conditions that cause abdominal pain like Inflammatory Bowel Diseases, cannot participate.You have major problems with your vision, hearing, or speaking.Children who have been diagnosed with developmental delays, autism, thought disorder, or bipolar disorder.You have severe symptoms of depression or are thinking about hurting yourself.You are afraid of being in small, enclosed spaces.You have a high score on a test for significant anxiety.You have been diagnosed with FAPD by a doctor and meet specific criteria for FAPD according to the ROME IV guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: ADAPT
- Group 2: Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to join this research experiment?
"According to the clinicaltrials.gov page, this research project is actively recruiting participants. The study was initially made public on July 3rd 2018 and its details were most recently modified on November 28th 2022."
Answered by AI
How many subjects are currently participating in this research project?
"Affirmative. The documentation found on clinicaltrials.gov reveals that this medical investigation, which was initially released on July 3rd 2018, is actively enrolling participants. Approximately 93 individuals must be recruited from 1 location."
Answered by AI
Who meets the criteria for taking part in this experiment?
"This clinical trial seeks 93 young individuals aged between 11 and 16 suffering from anxiety to participate. In order for their application to be considered, children must have a physician's diagnosis of FAPD using ROME IV criteria, an elevated GAD-7 score above 10 points, as well as fluency in English sufficient enough to complete the study measures and protocol."
Answered by AI
Is the age limit for participants in this research study over 25?
"This trial is open to those between the ages of 11 and 16. According to our data, there are currently 84 trials targeting minors and 295 for seniors."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger