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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: February 10, 2016
Last verified: February 2016
Results First Received: February 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Irritable Bowel Syndrome (IBS)
Functional Abdominal Pain
Fibromyalgia
Complex Regional Pain Syndrome (CRPS)
Myofacial Pain
Chronic Daily Headaches
Migraine Headaches
Chronic Pain
Intervention: Behavioral: Mentorship

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mentorship

Subjects randomly assigned to this arm received the specified "Mentorship Intervention"

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.

Control Subjects randomly assigned to this control group receive treatment as usual (TAU).
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.

Participant Flow:   Overall Study
    Mentorship     Control     Mentors  
STARTED     16     4     7  
COMPLETED     11     3     3  
NOT COMPLETED     5     1     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mentorship

Subjects randomly assigned to this arm received the specified "Mentorship Intervention"

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.

Control Subjects randomly assigned to this control group receive treatment as usual (TAU).
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.
Total Total of all reporting groups

Baseline Measures
    Mentorship     Control     Mentors     Total  
Number of Participants  
[units: participants]
  16     4     7     27  
Age  
[units: Years]
Mean (Standard Deviation)
  15.44  (1.71)     15.35  (0.31)     16.88  (1.49)     15.80  (1.62)  
Gender  
[units: participants]
       
Female     11     3     6     20  
Male     5     1     1     7  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     3     0     2     5  
Not Hispanic or Latino     9     3     5     17  
Unknown or Not Reported     4     1     0     5  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     0     0     3  
White     8     3     5     16  
More than one race     0     0     1     1  
Unknown or Not Reported     5     1     0     6  



  Outcome Measures

1.  Primary:   Adherence to Physician Recommended CAM Therapies   [ Time Frame: post intervention (week 8) ]

2.  Secondary:   Body Map and Pain Assessment   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Child Symptom Inventory (CSI)   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Child Anxiety Sensitivity Inventory (CASI) - Child Report   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Health Belief Scale (HBS) Short Version - Child Report   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Emotion Regulation Questionnaire (ERQ) - Child Answer   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Emotion Expression Scale for Children (EESC)   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Functional Disability Inventory (FDI)   [ Time Frame: baseline, weekly for weeks 1-8, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Revised Child Anxiety and Depression Scale (RCADS) Child Report   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Beck Depression Inventory 2 (BDI-2) #18   [ Time Frame: baseline, weekly weeks 1-8, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

12.  Secondary:   Child Health Questionnaire - Child Report (CHQ)   [ Time Frame: baseline, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Positive and Negative Affect Scale (PANAS)   [ Time Frame: baseline, weekly for weeks 1-8, 2 months, 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Lonnie K. Zeltzer, MD
Organization: Pediatric Pain and Palliative Care Program; University of California, Los Angeles
phone: 310-825-0731
e-mail: LZeltzer@mednet.ucla.edu


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

Responsible Party: Lonnie Zeltzer, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01118988     History of Changes
Other Study ID Numbers: 1R21HD057421-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: April 27, 2010
Results First Received: February 10, 2016
Last Updated: February 10, 2016
Health Authority: United States: Institutional Review Board