Functional Abdominal Pain SyndromeNCT03134950
Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
A study testing ADAPT in people with Functional Abdominal Pain Syndrome and Anxiety, run by Michigan State University at 1 site in United States.
Trial summary
This project aims to test a stepped care behavioral intervention approach for youth with functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening and a brief intervention (i.e. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Functional Abdominal Pain Syndrome, Anxiety
- What is being tested?
- ADAPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2015to 8 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with functional abdominal pain by a pediatric gastroenterologist
- clinically significant disability evidenced by a total score of > 7 on the Functional Disability Inventory (FDI) that remains elevated (>2) after 2 weeks
Who cannot join
- significant medical condition(s) with an identifiable organic cause (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Chron's Disease)
- documented developmental delay, severe cognitive impairment, or a thought disorder
- evidence of severe depressive symptoms (CDI 2: T score >80) and/or active suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Improving Care for Youth With Functional Abdominal Pain: A Stepped Care Cognitive Behavioral Therapy (CBT) Delivery Approach
This project aims to test a stepped care behavioral intervention approach for youth with functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth with FAP with more than minimal functional disability (FDI score >7) during their medical visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those that fail to respond to EUC (as evidenced by FDI score >7) are eligible to undergo a baseline assessment and then are randomized to receive either 1) a more intensive and tailored CBT approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.
Read the detailed description
The goal of this project is to pilot test different levels of behavioral intervention for patients diagnosed with FAP who are presenting for pediatric gastroenterology care. Patients are screened during their medical visit. Those with more than minimal levels of functional disability (Functional Disability Inventory (FDI) score >7), receive Enhanced Usual Care (EUC), brief pain-focused psychoeducation administered as part of their medical visit. As part of EUC, patients receive access to a web module for home use that reiterates educational material and offers relaxation training tools for home practice (i.e., audio recordings). Two weeks following EUC, patient outcomes are re-assessed with a focus on pain-related disability. Those who fail to respond to EUC (i.e., FDI remains >7) are invited to complete the next phase of the study. Eligible participants undergo a baseline assessment consisting of a diagnostic interview and child measures pertaining to pain, anxiety, depressive symptoms, and pain-related worries. Caregivers complete forms about their child's pain history, child disability, and child worries. Caregivers also complete a form about their own stress symptoms. After baseline assessment, patients are randomized to medical treatment as usual (TAU) or ADAPT, a tailored CBT delivered by a trained psychologist. ADAPT content differs based on the individual needs of the patient (i.e., all patients receive 4 pain-focused coping skills sessions, and those who present with clinical levels of anxiety receive 2 additional sessions to address anxiety symptoms). Participants complete 4 or 6 sessions (2 in person sessions and 2-4 web modules with phone support). Approximately six weeks after randomization, the patient and caregiver undergo follow-up assessment to assess pain, anxiety, and disability. It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and lower levels of anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.
- Conditions
- Functional Abdominal Pain Syndrome, Anxiety
- Being tested
- ADAPT
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPTBehavioural
Also called Aim to Decrease Anxiety and Pain Treatment
Aim to Decrease Anxiety and Pain Treatment is a tailored CBT ranging from 4 sessions (pain-focused) to 6 sessions (blend of pain and anxiety coping strategies depending on the needs of the individual patients. The first 2 sessions will be in person with a trained psychologist and the following 2-4 sessions will be web-based. Each web-based session will be followed by phone support.
| Study group | Role | What they receive |
|---|---|---|
| ADAPT | Experimental | Aim to Decrease Anxiety and Pain Treatment (ADAPT) is a tailored CBT ranging from 4 sessions (pain-focused) to 6 sessions (blend of pain and anxiety coping strategies depending on the needs of the individual patients. The first 2 sessions are in person with a trained psychologist and the following 2-4 sessions are web-based. Each web-based session is followed by phone support. Receives: Behavioral: ADAPT |
| Medical Treatment as Usual | No intervention | Medical treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability Inventory - Child Version (FDI-C)
A 15-item self report inventory measuring perceived pain-related disability
Measured: through study completion, an average of 8 weeks
Secondary outcomes (10)
Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)
Patient-reported measure of anxiety symptoms over the past 3 months
Measured: through study completion, an average of 8 weeks
Pain Intensity via a Visual Analog Scale (VAS)
Average pain levels in the past 2 weeks using a 0 -10 scale
Measured: through study completion, an average of 8 weeks
Anxiety Disorder Interview Schedule - Child Version (ADIS)
A validated interview conducted by a clinician to assess for childhood psychiatric disorders, with a focus on anxiety
Measured: through study completion, an average of 8 weeks
Child Depression Inventory 2 Self Report (CDI-2)
A self report inventory measuring symptoms of depression in children and adolescents.
Measured: through study completion, an average of 8 weeks
Pain Catastrophizing Scale for Children, Child Version (PCS-C)
An adaptation of the Pain Catastrophizing Scale used to study coping styles among child chronic pain patients.
Measured: through study completion, an average of 8 weeks
Functional Gastrointestinal Disorders (FGIDs) Questionnaire
This questionnaire is based off of the ROME III diagnostic criteria and is used to validate patients' FGID diagnosis. Administered by research staff.
Measured: through study completion, an average of 8 weeks
Children's Somatization Inventory (CSI-24)
A questionnaire that assesses the perceived severity of 24 nonspecific somatic symptoms. Items are based off of the symptom criteria for somatization disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM).
Measured: through study completion, an average of 8 weeks
Depression Anxiety Stress Scales (DASS21)
A brief self-report measure to assess parent negative-emotional states of depression, anxiety, and tension/stress.
Measured: through study completion, an average of 8 weeks
Children's Global Assessment Scale (C-GAS)
A 0-100 scale anchored with descriptors of the patient ranging from "extremely impaired" to "doing very well". The study clinician completes the C-GAS after the completion of the ADIS.
Measured: through study completion, an average of 8 weeks
Affective Reactivity Index (ARI)
A validated measure of irritability in pediatric populations
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start20 Jul 2015
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal Pain SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pain Society, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
- Investigators
- Natoshia Cunningham, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134950
- Sponsor's protocol ID
- 2015-1388
- Status last verified
- Mar 2021
- First submitted
- 12 Apr 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalomiris AE, Ely SL, Love SC, Mara CA, Cunningham NR. Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial. J Pain. 2022 May;23(5):810-821. doi: 10.1016/j.jpain.2021.12.001. Epub 2021 Dec 11.
PubMed 34902549Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.
PubMed 33130153
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Youth With Functional Abdominal Pain: A Stepped Care Cognitive Behavioral Therapy (CBT) Delivery Approach
- ClinicalTrials.gov ID
- NCT03134950
- Acronym / sponsor ID
- 2015-1388
- Conditions
- Functional Abdominal Pain Syndrome, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- American Pain Society, Children's Hospital Medical Center, Cincinnati
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 1 May 2017 (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.
This project aims to test a stepped care behavioral intervention approach for youth with functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth with FAP with more than minimal functional disability (FDI score >7) during their medical visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those that fail to respond to EUC (as evidenced by FDI score >7) are eligible to undergo a baseline assessment and then are randomized to receive either 1) a more intensive and tailored CBT approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.
Detailed description
The goal of this project is to pilot test different levels of behavioral intervention for patients diagnosed with FAP who are presenting for pediatric gastroenterology care. Patients are screened during their medical visit. Those with more than minimal levels of functional disability (Functional Disability Inventory (FDI) score >7), receive Enhanced Usual Care (EUC), brief pain-focused psychoeducation administered as part of their medical visit. As part of EUC, patients receive access to a web module for home use that reiterates educational material and offers relaxation training tools for home practice (i.e., audio recordings). Two weeks following EUC, patient outcomes are re-assessed with a focus on pain-related disability. Those who fail to respond to EUC (i.e., FDI remains >7) are invited to complete the next phase of the study. Eligible participants undergo a baseline assessment consisting of a diagnostic interview and child measures pertaining to pain, anxiety, depressive symptoms, and pain-related worries. Caregivers complete forms about their child's pain history, child disability, and child worries. Caregivers also complete a form about their own stress symptoms. After baseline assessment, patients are randomized to medical treatment as usual (TAU) or ADAPT, a tailored CBT delivered by a trained psychologist. ADAPT content differs based on the individual needs of the patient (i.e., all patients receive 4 pain-focused coping skills sessions, and those who present with clinical levels of anxiety receive 2 additional sessions to address anxiety symptoms). Participants complete 4 or 6 sessions (2 in person sessions and 2-4 web modules with phone support). Approximately six weeks after randomization, the patient and caregiver undergo follow-up assessment to assess pain, anxiety, and disability. It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and lower levels of anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADAPT | Experimental | Behavioral: ADAPTAim to Decrease Anxiety and Pain Treatment (ADAPT) is a tailored CBT ranging from 4 sessions (pain-focused) to 6 sessions (blend of pain and anxiety coping strategies depending on the needs of the individual patients. The first 2 sessions are in person with a trained psychologist and the following 2-4 sessions are web-based. Each web-based session is followed by phone support. |
| Medical Treatment as Usual | No intervention | –Medical treatment as usual |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosed with functional abdominal pain by a pediatric gastroenterologist
- clinically significant disability evidenced by a total score of > 7 on the Functional Disability Inventory (FDI) that remains elevated (>2) after 2 weeks
Key exclusion criteria (3 listed)
- significant medical condition(s) with an identifiable organic cause (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Chron's Disease)
- documented developmental delay, severe cognitive impairment, or a thought disorder
- evidence of severe depressive symptoms (CDI 2: T score >80) and/or active suicidal ideation
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 |
|---|---|---|
| ADAPTAlso: Aim to Decrease Anxiety and Pain TreatmentAim to Decrease Anxiety and Pain Treatment is a tailored CBT ranging from 4 sessions (pain-focused) to 6 sessions (blend of pain and anxiety coping strategies depending on the needs of the individual patients. The first 2 sessions will be in person with a trained psychologist and the following 2-4 sessions will be web-based. Each web-based session will be followed by phone support. | Behavioural | ADAPT |
Primary outcome
Functional Disability Inventory - Child Version (FDI-C)
Time frame: through study completion, an average of 8 weeks
A 15-item self report inventory measuring perceived pain-related disability
10 secondary outcomes
Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)
Time frame: through study completion, an average of 8 weeks
Pain Intensity via a Visual Analog Scale (VAS)
Time frame: through study completion, an average of 8 weeks
Anxiety Disorder Interview Schedule - Child Version (ADIS)
Time frame: through study completion, an average of 8 weeks
Child Depression Inventory 2 Self Report (CDI-2)
Time frame: through study completion, an average of 8 weeks
Pain Catastrophizing Scale for Children, Child Version (PCS-C)
Time frame: through study completion, an average of 8 weeks
Functional Gastrointestinal Disorders (FGIDs) Questionnaire
Time frame: through study completion, an average of 8 weeks
Children's Somatization Inventory (CSI-24)
Time frame: through study completion, an average of 8 weeks
Depression Anxiety Stress Scales (DASS21)
Time frame: through study completion, an average of 8 weeks
Children's Global Assessment Scale (C-GAS)
Time frame: through study completion, an average of 8 weeks
Affective Reactivity Index (ARI)
Time frame: through study completion, an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 34902549Kalomiris AE, Ely SL, Love SC, Mara CA, Cunningham NR. Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial. J Pain. 2022 May;23(5):810-821. doi: 10.1016/j.jpain.2021.12.001. Epub 2021 Dec 11.
- Derived from this study: PubMed 33130153Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.
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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. This study is not recruiting at the moment.
Natoshia Cunningham, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT in people with Functional Abdominal Pain Syndrome and Anxiety, run by Michigan State University at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 Mar 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Disability Inventory - Child Version (FDI-C) (time frame: through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134950, which also lists 2 linked publications.
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 9 Mar 2021.