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

Sponsor:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01118988

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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Abdominal Pain Anxiety Complex Regional Pain Syndrome Fibromyalgia Headache Migraine

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):

Allen LB, Tsao JC, Hayes LP, Zeltzer LK. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial. Trials. 2011 May 22;12:132.

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:

Abdominal Pain
Fibromyalgia
Myofascial Pain Syndromes
Headache
Irritable Bowel Syndrome
Migraine Disorders
Complex Regional Pain Syndromes
Facial Pain
Headache Disorders
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
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012