Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01118988
First received: April 27, 2010
Last updated: August 4, 2016
Last verified: August 2016
  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:


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 of CAM therapies recommended by the subjects' pain specialist physician.


Secondary Outcome Measures:
  • Body Map and Pain Assessment [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    visual depiction of body pain and associated pain ratings over certain periods of time and conditional situations

    Range: 0-19 body areas


  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    assessment of sleep quality

    Range: 0-21; higher scores = lower sleep quality


  • Child Symptom Inventory (CSI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    Assement of somatic symptom complaints

    24 items, range 0-96, higher score = more somatic symptoms


  • Child Anxiety Sensitivity Inventory (CASI) - Child Report [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    Assessment of child's anxiety sensitivity

    18 items, range 18-54, higher scores = more anxiety sensitivity


  • Health Belief Scale (HBS) Short Version - Child Report [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Number of treatment modalities rated 1-4 by participants on the HBS questionnaire, which asked participants to rate how much they think each of 16 listed treatment modalities would help with pain (1=Completely, 2=A lot, 3=Some, 4=A little, 5=Not at all).

  • Emotion Regulation Questionnaire (ERQ) - Child Answer [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    assessment of child emotion regulation

    Reappraisal subscale: 6 items, range 6-30, higher scores = higher use of reappraisal Suppression subscale: 4 items, range: 4-20, higher scores = higher use of suppression


  • Emotion Expression Scale for Children (EESC) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    assess child emotional expression/emotion regulation

    Poor Awareness subscale, 8 items, range: 8-40; higher scores = poorer emotional awareness Expressive Reluctance subscale, 8 items, range: 8-40; higher scores = more expressive reluctance


  • Functional Disability Inventory (FDI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    assesses functional disability for daily tasks

    Range: 0-60; higher scores mean greater functional disability.


  • Revised Child Anxiety and Depression Scale (RCADS) Child Report [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    assess levels of symptoms for anxiety disorders and depression

    Range: 0-141; Higher scores mean higher symptom level of anxiety 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

    Number reported is number of participants who reported any level of suicidal ideation or intent at any time and who were followed with the study's emergency protocol to ensure that such participants are not a threat to self or others, and that he/she was under the appropriate mental health care.


  • Child Health Questionnaire - Child Report (CHQ) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    detailed questionnaire about health, daily activites, pain, behavior, family health, self-esteem

    Subscales (for all subscales, higher scores = better health):

    Behavior - 16 items, averaged, range 1-5 Bodily Pain and Discomfort - 2 items, averaged, range 1-6 Change in Health - 1 item, range 1-5 Family Activities - 6 items, averaged, range 1-5 Family Cohesion - 1 item, range 1-5 Global Health - 1 item, range 1-5 Global Behavior - 1 item, range 1-5 General Health - 12 items, averaged, range 1-5 Mental Health - 16 items, averaged, range 1-5 Physical Functioning - 9 items, averaged, range 1-4 Role/Social Limitations Behavioral - 3 items, range 1-4 Role/Social Limitations Emotional - 3 items, range 1-4 Role/Social Limitations Physical - 3 items, range 1-4 Self-Esteem - 14 items, range 1-5


  • Positive and Negative Affect Scale (PANAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    assesses extent to which children have felt a number of positive and negative affects

    Positive Affect subscale, 12 items, range: 12-60, higher score = more positive affect Negative Affect subscale, 15 items, range: 15-75, higher score = more negative affect



Enrollment: 27
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118988

Locations
United States, California
UCLA Pediatric Pain Management Clinic
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Lonnie K. Zeltzer, MD UCLA Department of Pediatrics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lonnie Zeltzer, Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01118988     History of Changes
Other Study ID Numbers: 1R21HD057421-01A2 
Study First Received: April 27, 2010
Results First Received: February 10, 2016
Last Updated: August 4, 2016
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
Syndrome
Fibromyalgia
Irritable Bowel Syndrome
Chronic Pain
Headache
Abdominal Pain
Migraine Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Facial Pain
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2016