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Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01118988
First received: April 27, 2010
Last updated: May 14, 2010
Last verified: March 2010
History of Changes
  Purpose

This protocol matches child subjects with peer mentors of similar age who have learned to function successfully with a chronic pain disorder. The trained mentors will present information to the subjects in a supervised and monitored interaction via telephone and computer for 2 months and encourage participation in skill-building programs. Children will be tested for improvement in pain and functioning at 2 months and again at 4 months to see if improvements persist. The investigators hypothesize that children who received peer mentor support will show more improvement in pain and functioning at 2 and 4 months into treatment than those in a control group who do not receive mentor support.


Condition Intervention
Irritable Bowel Syndrome (IBS)
Functional Abdominal Pain
Fibromyalgia
Complex Regional Pain Syndrome (CRPS)
Myofacial Pain
Chronic Daily Headaches
Migraine Headaches
Chronic Pain
 Behavioral: Mentorship

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Adherence to physician recommended CAM therapies [ Time Frame: post intervention (week 8) ] [ Designated as safety issue: No ]
    This measure tracks the attendance and utilizations of CAM therapies recommended by the subjects' pain specialist physician


Secondary Outcome Measures:
  • Body Map and Pain assessment [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    visual depiction of body pain and associated pain ratings over certain periods of time and conditional situations

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    assessment of sleep quality

  • Child Symptom Inventory (CSI) [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Assement of somatic symptom complaints

  • Child Anxiety Sensitivity Inventory (CASI) - Child Report [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Assessment of child's anxiety sensitivity

  • Health Belief Scale (HBS) Short Version - Child Report [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    assesses patient belief about different modalities for pain treatment

  • Emotion Regulation Questionnaire (ERQ) - Child Answer [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    assessment of child emotion regulation

  • Emotion Expression Scale for Children (EESC) [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    assess child emotional expression/emotion regulation

  • Functional Disability Inventory (FDI) [ Time Frame: baseline, weekly for weeks 1-8, 2 months, 4 months ] [ Designated as safety issue: No ]
    assesses functional disability for daily tasks

  • Revised Child Anxiety and Depression Scale (RCADS) child report [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    assess levels of symptoms for anxiety disorders and depression

  • Beck Depression Inventory 2 (BDI-2) #18 [ Time Frame: baseline, weekly weeks 1-8, 2 months, 4 months ] [ Designated as safety issue: Yes ]
    assesses suicidal ideation and intent

  • Child Health Questionnaire - Child Report (CHQ) [ Time Frame: baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    detailed questionnaire about health, daily activites, pain, behavior, family health, self-esteem

  • Positive and Negative Affect Scale (PANAS) [ Time Frame: baseline, weekly for weeks 1-8, 2 months, 4 months ] [ Designated as safety issue: No ]
    assesses extent to which children have felt a number of positive and negative affects


Estimated Enrollment: 56
Study Start Date: December 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mentorship
Subjects randomly assigned to this arm received the specified "Mentorship Intervention"
 Behavioral: Mentorship
Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties.
Other Names:
  • support
  • education
No Intervention: Control
Subjects randomly assigned to this control group receive treatment as usual (TAU).
No Intervention: Mentors
Subjects recruited to the "Mentor" arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Mentors

Inclusion criteria:

  • between the ages of 14 and 18
  • any patient who has been successfully treated in the UCLA Pediatric Pain Program
  • access to telephone
  • access to internet enabled computer

Exclusion criteria

  • younger than 14
  • older than 18
  • new patient
  • no access to telephone
  • no access to internet enabled computer

Mentees and controls:

Inclusion Criteria:

  • chronic pain diagnosis
  • between the ages of 12 and 17
  • access to telephone
  • access to internet enabled computer
  • new to UCLA Pediatric Pain Clinic
  • plans to utilize program CAM therapies

Exclusion Criteria:

  • already utilizing UCLA Pediatric Pain Program CAM therapies
  • unable to read, speak, or understand english
  • younger than 12 or older than 17
  • no access to telephone
  • no access to internet enabled computer
  • not new patient to UCLA Pediatric Pain Clinic
  • does not plan to utilize program CAM therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118988

Contacts
Contact: Lonnie K Zeltzer, MD 310-825-0731 LZeltzer@mednet.ucla.edu
Contact: Jennie CI Tsao, Ph.D. 310-825-0731 JTsao@mednet.ucla.edu

Locations
United States, California
UCLA Pediatric Pain Management Clinic Recruiting
Los Angeles, California, United States, 90095
Contact: Lonnie K Zeltzer, MD     310-825-0731     LZeltzer@mednet.ucla.edu    
Principal Investigator: Lonnie K Zeltzer, MD            
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Lonnie K. Zeltzer, MD UCLA Department of Pediatrics
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lonnie K. Zeltzer, MD/Professor, Director of UCLA Pediatric Pain Program, UCLA Department of Pediatrics
ClinicalTrials.gov Identifier: NCT01118988     History of Changes
Other Study ID Numbers: 1 R21 HD057421-01A2
Study First Received: April 27, 2010
Last Updated: May 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Peer Support
Social Support
Chronic Pain
Behavioral Interventions for Pain
Adolescents
Children
Pediatric
 Mentorship
Complementary and Alternative Medicine
CAM
Pain
Pain Management
Behavioral

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Primary
Abdominal Pain
Fibromyalgia
Myofascial Pain Syndromes
Headache
Irritable Bowel Syndrome
Migraine Disorders
Complex Regional Pain Syndromes
Facial Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Muscular Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Brain Diseases
Central Nervous System Diseases
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013