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

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ClinicalTrials.gov Identifier: NCT01118988

Recruitment Status : Completed

First Posted : May 7, 2010

Results First Posted : March 9, 2016

Last Update Posted : September 30, 2016

Sponsor:

Information provided by (Responsible Party):

Lonnie Zeltzer, University of California, Los Angeles

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome (IBS) Functional Abdominal Pain Fibromyalgia Complex Regional Pain Syndrome (CRPS) Myofacial Pain Chronic Daily Headaches Migraine Headaches Chronic Pain	Behavioral: Mentorship	Not Applicable

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents
Study Start Date :	December 2009
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Complex Regional Pain Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

Adherence to Physician Recommended CAM Therapies [ Time Frame: post intervention (week 8) ]
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 ]
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 ]
assessment of sleep quality

Range: 0-21; higher scores = lower sleep quality
Child Symptom Inventory (CSI) [ Time Frame: 2 months ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):

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. doi: 10.1186/1745-6215-12-132.


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 ( U.S. NIH Grant/Contract )
First Posted:	May 7, 2010 Key Record Dates
Results First Posted:	March 9, 2016
Last Update Posted:	September 30, 2016
Last Verified:	August 2016

Keywords provided by Lonnie Zeltzer, 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:


Syndrome Chronic Pain Headache Fibromyalgia Irritable Bowel Syndrome Abdominal Pain Migraine Disorders Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Headache Disorders Facial Pain Disease Pathologic Processes Pain Neurologic Manifestations	Nervous System Diseases Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive Headache Disorders, Primary Brain Diseases Central Nervous System Diseases

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