Pediatric Abdominal PainMCAPNCT01620606
Managing Childhood Abdominal Pain
A study testing Cognitive Behavioral Therapy & Social Learning and Education and Support in people with Pediatric Abdominal Pain, run by University of Washington at 3 sites in United States.
Trial summary
Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pediatric Abdominal Pain
- What is being tested?
- Cognitive Behavioral Therapy & Social Learning and Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to May 2017
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is 7 to 12 years old
- The child experienced at least three episodes of unexplained abdominal pain over a three month period which affected the child's activities
- The child lived with the primary caregiver for at least the last 3 months
- The child and the parent agree to the conditions of study participation, including randomization, participation in intervention and follow-up evaluations
- The parent and child comprehend and speak English without assistance
Who cannot join
- The child has positive physical or laboratory findings which would explain the abdominal pain
- The child has a chronic disease (e.g. Crohn's, ulcerative colitis, pancreatitis, diabetes, epilepsy, etc.)
- The child is lactose intolerant
- The child had major surgery in the past year
- The parent or child has developmental disabilities that require full-time special education or that impair ability to respond to assessment measures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina
Seattle Children's Hospital
Seattle, Washington, 98105
Mary Bridge Children's Hospital
Tacoma, Washington, 98405
About this study
Official title: Parent Training to Address Pediatric Functional Abdominal Pain
Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.
Read the detailed description
Functional Abdominal Pain (FAP) affects 10 to 15% of children and has significant social, emotional, and financial costs, but no known organic cause and no accepted medical or behavioral treatment. The researchers have conducted studies that provide support for a theoretical model in which cognitive-behavioral and social learning processes (modeling and/or potentially reinforcing responses by parents) may contribute to the maintenance of illness behaviors and functional disability in children with FAP. The researchers subsequently tested a social learning and cognitive-behavioral intervention for parent-child dyads which focused on changing these parent behaviors as well as teaching coping skills to children. Results support the effectiveness of the intervention and the explanatory value of the theory, demonstrating that parental change is a key element in reducing children's symptoms. The proposed study will build on these findings by evaluating a parent-only intervention. Furthermore, our experience and that of other investigators indicates that alternative intervention models are needed for wider accessibility to the intervention for families in need. While a parent-only format is expected to increase accessibility, we will also evaluate the use of a remote telephone intervention.
- Conditions
- Pediatric Abdominal Pain
- Being tested
- Cognitive Behavioral Therapy & Social Learning, Education and Support
- Keywords
- FAP, RAP, Abdominal Pain, IBS
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy & Social LearningBehavioural
Cognitive Behavioral Therapy \& Social Learning
Education and SupportBehavioural
Education about the GI system, nutrition and food safety
| Study group | Role | What they receive |
|---|---|---|
| SLCBT | Experimental | Social Learning and Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy & Social Learning |
| SLCBT-R | Experimental | Phone-based Social Learning and Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy & Social Learning |
| ES | Active comparator | Education and Support Receives: Behavioral: Education and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain Index
Measured: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Secondary outcomes (4)
Adults' Responses to Children's Symptoms
Measured: Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Pain Response Inventory
Measured: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Pain Beliefs Questionnaire
Measured: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Pain Catastrophizing Scale
Measured: Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Abdominal PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, MultiCare Mary Bridge Children's Hospital & Health Center
- Responsible party
- Principal investigator, Rona Levy, University of Washington
- Investigators
- Rona L Levy, MSW, MPH, PhD, Principal investigator, University of WashingtonMiranda vanTilburg, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620606
- Sponsor's protocol ID
- 13744 SCH
- Acronym
- MCAP
- Status last verified
- Apr 2021
- First submitted
- 14 Feb 2012
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy RL, Langer SL, van Tilburg MAL, Romano JM, Murphy TB, Walker LS, Mancl LA, Claar RL, DuPen MM, Whitehead WE, Abdullah B, Swanson KS, Baker MD, Stoner SA, Christie DL, Feld AD. Brief telephone-delivered cognitive behavioral therapy targeted to parents of children with functional abdominal pain: a randomized controlled trial. Pain. 2017 Apr;158(4):618-628. doi: 10.1097/j.pain.0000000000000800.
PubMed 28301859
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training to Address Pediatric Functional Abdominal Pain
- ClinicalTrials.gov ID
- NCT01620606
- Acronym / sponsor ID
- MCAP / 13744 SCH
- Conditions
- Pediatric Abdominal Pain
- Keywords
- FAP, RAP, Abdominal Pain, IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of North Carolina, MultiCare Mary Bridge Children's Hospital & Health Center
- Study start
- Sep 2011
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Jun 2012 (estimated)
- 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.
Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.
Detailed description
Functional Abdominal Pain (FAP) affects 10 to 15% of children and has significant social, emotional, and financial costs, but no known organic cause and no accepted medical or behavioral treatment. The researchers have conducted studies that provide support for a theoretical model in which cognitive-behavioral and social learning processes (modeling and/or potentially reinforcing responses by parents) may contribute to the maintenance of illness behaviors and functional disability in children with FAP. The researchers subsequently tested a social learning and cognitive-behavioral intervention for parent-child dyads which focused on changing these parent behaviors as well as teaching coping skills to children. Results support the effectiveness of the intervention and the explanatory value of the theory, demonstrating that parental change is a key element in reducing children's symptoms. The proposed study will build on these findings by evaluating a parent-only intervention. Furthermore, our experience and that of other investigators indicates that alternative intervention models are needed for wider accessibility to the intervention for families in need. While a parent-only format is expected to increase accessibility, we will also evaluate the use of a remote telephone intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLCBT | Experimental | Behavioral: Cognitive Behavioral Therapy & Social LearningSocial Learning and Cognitive Behavioral Therapy |
| SLCBT-R | Experimental | Behavioral: Cognitive Behavioral Therapy & Social LearningPhone-based Social Learning and Cognitive Behavioral Therapy |
| ES | Active comparator | Behavioral: Education and SupportEducation and Support |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child is 7 to 12 years old
- The child experienced at least three episodes of unexplained abdominal pain over a three month period which affected the child's activities
- The child lived with the primary caregiver for at least the last 3 months
- The child and the parent agree to the conditions of study participation, including randomization, participation in intervention and follow-up evaluations
- The parent and child comprehend and speak English without assistance
Key exclusion criteria (5 listed)
- The child has positive physical or laboratory findings which would explain the abdominal pain
- The child has a chronic disease (e.g. Crohn's, ulcerative colitis, pancreatitis, diabetes, epilepsy, etc.)
- The child is lactose intolerant
- The child had major surgery in the past year
- The parent or child has developmental disabilities that require full-time special education or that impair ability to respond to assessment measures
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 |
|---|---|---|
| Cognitive Behavioral Therapy & Social LearningCognitive Behavioral Therapy \& Social Learning | Behavioural | SLCBT, SLCBT-R |
| Education and SupportEducation about the GI system, nutrition and food safety | Behavioural | ES |
Primary outcome
Abdominal Pain Index
Time frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
4 secondary outcomes
Adults' Responses to Children's Symptoms
Time frame: Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Pain Response Inventory
Time frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Pain Beliefs Questionnaire
Time frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
Pain Catastrophizing Scale
Time frame: Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3
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 27 Apr 2021.
- Derived from this study: PubMed 28301859Levy RL, Langer SL, van Tilburg MAL, Romano JM, Murphy TB, Walker LS, Mancl LA, Claar RL, DuPen MM, Whitehead WE, Abdullah B, Swanson KS, Baker MD, Stoner SA, Christie DL, Feld AD. Brief telephone-delivered cognitive behavioral therapy targeted to parents of children with functional abdominal pain: a randomized controlled trial. Pain. 2017 Apr;158(4):618-628. doi: 10.1097/j.pain.0000000000000800.
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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.
Rona L Levy, MSW, MPH, PhD principal investigator
University of Washington
Miranda vanTilburg, PhD principal investigator
University of North Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy & Social Learning and Education and Support in people with Pediatric Abdominal Pain, run by University of Washington at 3 sites 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 5 inclusion and 5 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Abdominal Pain Index (time frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3). 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 NCT01620606, which also lists 1 linked publication.
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 27 Apr 2021.