Trial Outcomes & Findings for Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents (NCT NCT01118988)

NCT ID: NCT01118988

Last Updated: 2016-09-30

Results Overview

This measure tracks the attendance of CAM therapies recommended by the subjects' pain specialist physician.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: post intervention (week 8)
• Results posted on: 2016-09-30

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	16	4	7
Overall Study COMPLETED	11	3	3
Overall Study NOT COMPLETED	5	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mentorship n=16 Participants 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 n=4 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).	Mentors n=7 Participants 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 n=27 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Age, Continuous	15.44 Years STANDARD_DEVIATION 1.71 • n=5 Participants	15.35 Years STANDARD_DEVIATION 0.31 • n=7 Participants	16.88 Years STANDARD_DEVIATION 1.49 • n=5 Participants	15.80 Years STANDARD_DEVIATION 1.62 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants

PRIMARY outcome

Timeframe: post intervention (week 8)

Population: One participant in the Mentorship group did not do the weekly CAM therapy tracking and is thus not included in the results for this measure.

This measure tracks the attendance of CAM therapies recommended by the subjects' pain specialist physician.

Outcome measures

Measure	Mentorship n=10 Participants 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 n=3 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Adherence to Physician Recommended CAM Therapies	1.34 Visits to CAM therapists per week Standard Deviation 0.64	2.23 Visits to CAM therapists per week Standard Deviation 1.19

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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

Range: 0-19 body areas

Outcome measures

Measure	Mentorship n=9 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Body Map and Pain Assessment	7.56 Number of painful body areas Standard Deviation 6.69	8.50 Number of painful body areas Standard Deviation 6.36

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

assessment of sleep quality

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

Outcome measures

Measure	Mentorship n=6 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Pittsburgh Sleep Quality Index (PSQI)	9.67 units on a scale Standard Deviation 4.13	7.50 units on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

Assement of somatic symptom complaints

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Child Symptom Inventory (CSI)	33.64 units on a scale Standard Deviation 17.04	26.00 units on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

Assessment of child's anxiety sensitivity

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Child Anxiety Sensitivity Inventory (CASI) - Child Report	29.38 units on a scale Standard Deviation 5.73	24.50 units on a scale Standard Deviation 6.36

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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).

Outcome measures

Measure	Mentorship n=9 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Health Belief Scale (HBS) Short Version - Child Report	10.89 Number of treatments Standard Deviation 3.14	10.00 Number of treatments Standard Deviation 0.00

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Emotion Regulation Questionnaire (ERQ) - Child Answer Reappraisal	23.63 units on a scale Standard Deviation 4.96	25.00 units on a scale Standard Deviation 1.41
Emotion Regulation Questionnaire (ERQ) - Child Answer Suppression	9.38 units on a scale Standard Deviation 3.02	9.00 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Emotion Expression Scale for Children (EESC) Poor Awareness	16.88 units on a scale Standard Deviation 4.97	10.0 units on a scale Standard Deviation 1.41
Emotion Expression Scale for Children (EESC) Expressive Reluctance	16.75 units on a scale Standard Deviation 6.92	12.0 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

assesses functional disability for daily tasks

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Functional Disability Inventory (FDI)	25.88 units on a scale Standard Deviation 16.57	18.00 units on a scale Standard Deviation 8.49

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

assess levels of symptoms for anxiety disorders and depression

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Revised Child Anxiety and Depression Scale (RCADS) Child Report	39.44 units on a scale Standard Deviation 20.32	20.00 units on a scale Standard Deviation 12.73

SECONDARY outcome

Timeframe: baseline, weekly weeks 1-8, 2 months, 4 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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.

Outcome measures

Measure	Mentorship n=9 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Beck Depression Inventory 2 (BDI-2) #18	1 participants	0 participants

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Child Health Questionnaire - Child Report (CHQ) Behavior Sub-Scale	4.12 units on a scale Standard Deviation .54	4.66 units on a scale Standard Deviation .07
Child Health Questionnaire - Child Report (CHQ) Bodily Pain and Discomfort Sub-Scale	1.69 units on a scale Standard Deviation .59	2.50 units on a scale Standard Deviation 0.00
Child Health Questionnaire - Child Report (CHQ) Change in Health Item Sub-Scale	2.71 units on a scale Standard Deviation 1.38	2.50 units on a scale Standard Deviation .71
Child Health Questionnaire - Child Report (CHQ) Family Activities Sub-Scale	3.26 units on a scale Standard Deviation .99	3.63 units on a scale Standard Deviation .05
Child Health Questionnaire - Child Report (CHQ) Family Cohesion Item Sub-Scale	4.17 units on a scale Standard Deviation .90	3.90 units on a scale Standard Deviation .71
Child Health Questionnaire - Child Report (CHQ) Global Health Item Sub-Scale	2.33 units on a scale Standard Deviation 1.30	3.30 units on a scale Standard Deviation 1.56
Child Health Questionnaire - Child Report (CHQ) Global Behavior Item Sub-Scale	4.20 units on a scale Standard Deviation 1.05	4.70 units on a scale Standard Deviation .42
Child Health Questionnaire - Child Report (CHQ) General Health Perceptions Sub-Scale	2.50 units on a scale Standard Deviation .84	2.61 units on a scale Standard Deviation .13
Child Health Questionnaire - Child Report (CHQ) Mental Health Sub-Scale	3.67 units on a scale Standard Deviation .48	3.81 units on a scale Standard Deviation .35
Child Health Questionnaire - Child Report (CHQ) Physical Functioning Sub-Scale	2.87 units on a scale Standard Deviation .86	3.67 units on a scale Standard Deviation .16
Child Health Questionnaire - Child Report (CHQ) Role/Social Limitations due to Behavioral Difficul	3.42 units on a scale Standard Deviation 1.05	4.00 units on a scale Standard Deviation 0.00
Child Health Questionnaire - Child Report (CHQ) Role/Social Limitations due to Emotional Difficult	2.96 units on a scale Standard Deviation 1.25	3.50 units on a scale Standard Deviation .71
Child Health Questionnaire - Child Report (CHQ) Role/Social Limitations due to Physical Health	2.13 units on a scale Standard Deviation 1.25	3.17 units on a scale Standard Deviation .24
Child Health Questionnaire - Child Report (CHQ) Self-Esteem Sub-Scale	3.64 units on a scale Standard Deviation .76	3.58 units on a scale Standard Deviation .92

SECONDARY outcome

Timeframe: 2 months

Population: Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.

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

Outcome measures

Measure	Mentorship n=8 Participants 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 n=2 Participants Subjects randomly assigned to this control group receive treatment as usual (TAU).
Positive and Negative Affect Scale (PANAS) Positive Affect	38.95 units on a scale Standard Deviation 9.60	32.00 units on a scale Standard Deviation 8.49
Positive and Negative Affect Scale (PANAS) Negative Affect	29.38 units on a scale Standard Deviation 8.45	24.00 units on a scale Standard Deviation 8.49

Adverse Events

Mentorship

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mentors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lonnie K. Zeltzer, MD

Pediatric Pain and Palliative Care Program; University of California, Los Angeles

Phone: 310-825-0731

Email: LZeltzer@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place