Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents
Irritable Bowel Syndrome (IBS)
Functional Abdominal Pain
Complex Regional Pain Syndrome (CRPS)
Chronic Daily Headaches
|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|
- 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.
- 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
|Study Start Date:||December 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Subjects randomly assigned to this arm received the specified "Mentorship Intervention"
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.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01118988
|United States, California|
|UCLA Pediatric Pain Management Clinic|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Lonnie K. Zeltzer, MD||UCLA Department of Pediatrics|