Abdominal PainPhase 2NCT00494260
Managing Recurrent Abdominal Pain
A Phase 2 study testing Social Learning and Cognitive Behavioral Therapy (SLCBT) and Education Support (ES) in people with Abdominal Pain, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Social Learning and Cognitive Behavioral Therapy (SLCBT) and Education Support (ES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2003to Jun 2010
- Phase
- Phase 2
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities
- primary caregiver willing and able to complete questionnaires
- child aged 7-17
- child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime
Who cannot join
- positive physical or laboratory findings which would explain the child's abdominal pain
- chronic disease
- major surgery in past year
- developmental disabilities that require full-time special education or impair ability to respond
- inability to comprehend English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Goryeb Children's Hospital/ Atlantic Health System
Morristown, New Jersey, 07962
University of Washington/ Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
About this study
Official title: Intergenerational Transmission of Illness Behavior
The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).
Read the detailed description
Recurrent Abdominal Pain (RAP) is one of many disorders in adults and children for which there is no identifiable organic or physiological cause, yet which is associated with illness behavior that has significant societal and personal costs. Although 10-15% of children have RAP, there is at present no accepted medical or behavioral treatment for it. We have conducted a series of studies that suggests that illness behavior is, at least in part, learned during childhood when parents model sick role behavior or respond to their children's somatic complaints in a way that encourages or reinforces sick role behavior. The goal of this project is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with RAP.
The study is a randomized clinical trial. Children with RAP are assigned to one of two treatment conditions: 1) a social learning and cognitive behavior therapy condition (SLCBT) or 2) an education and support condition (ES). The SLCBT protocol teaches parents and children cognitive-behavioral methods such as relaxation and coping for managing RAP pain and stress. Patients and parents in the ES condition receive educational information regarding nutrition and the gastrointestinal system. Both treatment arms consist of three sessions with a mental health professional, each one week apart.
Study families are recruited from physicians in the community and through community flyers and newsletters. Outcome measures are collected at baseline, end of treatment, and at follow-up evaluations conducted three, six and 12 months later. Measures are designed to assess: RAP symptoms, health care utilization, psychological symptoms, school absences, functional disabilities, and family stress).
Primary Hypothesis: Children in the SLCBT condition will exhibit a greater decrease in symptoms of RAP and related maladaptive behaviors and cognitions than children in a comparison condition.
- Conditions
- Abdominal Pain
- Being tested
- Social Learning and Cognitive Behavioral Therapy (SLCBT), Education Support (ES)
- Keywords
- recurrent abdominal pain, illness behavior, social learning, cognitive behavioral therapy
- Medical subject headings
- Abdominal Pain, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Learning and Cognitive Behavioral Therapy (SLCBT)Behavioural
The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques
Education Support (ES)Behavioural
The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention.
| Study group | Role | What they receive |
|---|---|---|
| Social learning and cognitive behavioral therapy (SLCBT) | Experimental | The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques. Receives: Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT) |
| Education Support (ES) | Active comparator | The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention. Receives: Behavioral: Education Support (ES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of recurrent abdominal pain
Measured: measured one week following treatment and again in 3, 6 and 12 months
disability
Measured: measured one week following treatment and again in 3, 6 and 12 months
Secondary outcomes (2)
parent behaviors
Measured: measured one week following treatment and again in 3, 6 and 12 months
child coping behaviors
Measured: measured one week following treatment and again in 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startNov 2003
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rona Levy, PhD, Principal investigator, School of Social Work, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494260
- Sponsor's protocol ID
- R01HD036069-07
- Status last verified
- Mar 2016
- First submitted
- 28 Jun 2007
- Last updated
- 31 Mar 2016
- Results posted
- No
Publications
Levy RL, Whitehead WE, Walker LS, Von Korff M, Feld AD, Garner M, Christie D. Increased somatic complaints and health-care utilization in children: effects of parent IBS status and parent response to gastrointestinal symptoms. Am J Gastroenterol. 2004 Dec;99(12):2442-51. doi: 10.1111/j.1572-0241.2004.40478.x.
PubMed 15571594Levy RL, Whitehead WE, Von Korff MR, Feld AD. Intergenerational transmission of gastrointestinal illness behavior. Am J Gastroenterol. 2000 Feb;95(2):451-6. doi: 10.1111/j.1572-0241.2000.01766.x.
PubMed 10685749Levy RL, Langer SL, Walker LS, Romano JM, Christie DL, Youssef N, DuPen MM, Ballard SA, Labus J, Welsh E, Feld LD, Whitehead WE. Twelve-month follow-up of cognitive behavioral therapy for children with functional abdominal pain. JAMA Pediatr. 2013 Feb;167(2):178-84. doi: 10.1001/2013.jamapediatrics.282.
PubMed 23277304
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intergenerational Transmission of Illness Behavior
- ClinicalTrials.gov ID
- NCT00494260
- Acronym / sponsor ID
- R01HD036069-07
- Conditions
- Abdominal Pain
- Keywords
- recurrent abdominal pain, illness behavior, social learning, cognitive behavioral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Nov 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Jun 2007 (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.
The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).
Detailed description
Recurrent Abdominal Pain (RAP) is one of many disorders in adults and children for which there is no identifiable organic or physiological cause, yet which is associated with illness behavior that has significant societal and personal costs. Although 10-15% of children have RAP, there is at present no accepted medical or behavioral treatment for it. We have conducted a series of studies that suggests that illness behavior is, at least in part, learned during childhood when parents model sick role behavior or respond to their children's somatic complaints in a way that encourages or reinforces sick role behavior. The goal of this project is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with RAP.
The study is a randomized clinical trial. Children with RAP are assigned to one of two treatment conditions: 1) a social learning and cognitive behavior therapy condition (SLCBT) or 2) an education and support condition (ES). The SLCBT protocol teaches parents and children cognitive-behavioral methods such as relaxation and coping for managing RAP pain and stress. Patients and parents in the ES condition receive educational information regarding nutrition and the gastrointestinal system. Both treatment arms consist of three sessions with a mental health professional, each one week apart.
Study families are recruited from physicians in the community and through community flyers and newsletters. Outcome measures are collected at baseline, end of treatment, and at follow-up evaluations conducted three, six and 12 months later. Measures are designed to assess: RAP symptoms, health care utilization, psychological symptoms, school absences, functional disabilities, and family stress).
Primary Hypothesis: Children in the SLCBT condition will exhibit a greater decrease in symptoms of RAP and related maladaptive behaviors and cognitions than children in a comparison condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social learning and cognitive behavioral therapy (SLCBT) | Experimental | Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT)The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques. |
| Education Support (ES) | Active comparator | Behavioral: Education Support (ES)The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities
- primary caregiver willing and able to complete questionnaires
- child aged 7-17
- child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime
Key exclusion criteria (5 listed)
- positive physical or laboratory findings which would explain the child's abdominal pain
- chronic disease
- major surgery in past year
- developmental disabilities that require full-time special education or impair ability to respond
- inability to comprehend English
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 |
|---|---|---|
| Social Learning and Cognitive Behavioral Therapy (SLCBT)The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques | Behavioural | Social learning and cognitive behavioral therapy (SLCBT) |
| Education Support (ES)The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention. | Behavioural | Education Support (ES) |
Primary outcome
symptoms of recurrent abdominal pain
Time frame: measured one week following treatment and again in 3, 6 and 12 months
disability
Time frame: measured one week following treatment and again in 3, 6 and 12 months
2 secondary outcomes
parent behaviors
Time frame: measured one week following treatment and again in 3, 6 and 12 months
child coping behaviors
Time frame: measured one week following treatment and again in 3, 6 and 12 months
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 31 Mar 2016.
- Background: PubMed 15571594Levy RL, Whitehead WE, Walker LS, Von Korff M, Feld AD, Garner M, Christie D. Increased somatic complaints and health-care utilization in children: effects of parent IBS status and parent response to gastrointestinal symptoms. Am J Gastroenterol. 2004 Dec;99(12):2442-51. doi: 10.1111/j.1572-0241.2004.40478.x.
- Background: PubMed 10685749Levy RL, Whitehead WE, Von Korff MR, Feld AD. Intergenerational transmission of gastrointestinal illness behavior. Am J Gastroenterol. 2000 Feb;95(2):451-6. doi: 10.1111/j.1572-0241.2000.01766.x.
- Derived from this study: PubMed 23277304Levy RL, Langer SL, Walker LS, Romano JM, Christie DL, Youssef N, DuPen MM, Ballard SA, Labus J, Welsh E, Feld LD, Whitehead WE. Twelve-month follow-up of cognitive behavioral therapy for children with functional abdominal pain. JAMA Pediatr. 2013 Feb;167(2):178-84. doi: 10.1001/2013.jamapediatrics.282.
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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 Levy, PhD principal investigator
School of Social Work, University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Social Learning and Cognitive Behavioral Therapy (SLCBT) and Education Support (ES) in people with Abdominal Pain, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 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 4 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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
symptoms of recurrent abdominal pain (time frame: measured one week following treatment and again in 3, 6 and 12 months). 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?
On the ClinicalTrials.gov record for NCT00494260, which also lists 3 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 31 Mar 2016.