NCT01118988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

March 9, 2016

Completed
Last Updated

September 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

April 27, 2010

Results QC Date

February 10, 2016

Last Update Submit

August 4, 2016

Conditions

Keywords

Peer SupportSocial SupportChronic PainBehavioral Interventions for PainAdolescentsChildrenPediatricMentorshipComplementary and Alternative MedicineCAMPainPain ManagementBehavioral

Outcome Measures

Primary Outcomes (1)

  • Adherence to Physician Recommended CAM Therapies

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

    post intervention (week 8)

Secondary Outcomes (12)

  • Body Map and Pain Assessment

    2 months

  • Pittsburgh Sleep Quality Index (PSQI)

    2 months

  • Child Symptom Inventory (CSI)

    2 months

  • Child Anxiety Sensitivity Inventory (CASI) - Child Report

    2 months

  • Health Belief Scale (HBS) Short Version - Child Report

    2 months

  • +7 more secondary outcomes

Study Arms (3)

Mentorship

EXPERIMENTAL

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

Behavioral: Mentorship

Control

NO INTERVENTION

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

Mentors

NO INTERVENTION

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.

Interventions

MentorshipBEHAVIORAL

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.

Also known as: support, education
Mentorship

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • younger than 14
  • older than 18
  • new patient
  • no access to telephone
  • no access to internet enabled computer
  • Mentees and controls:
  • 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
  • already utilizing UCLA Pediatric Pain Program CAM therapies
  • unable to read, speak, or understand english
  • younger than 12 or older than 17
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Pediatric Pain Management Clinic

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Irritable Bowel SyndromeFibromyalgiaComplex Regional Pain SyndromesFacial PainHeadache DisordersMigraine DisordersChronic PainPainAgnosiaBehavior

Interventions

Palliative CareEducational Status

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesAutonomic Nervous System DiseasesPeripheral Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesHeadache Disorders, PrimaryPerceptual DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Dr. Lonnie K. Zeltzer, MD
Organization
Pediatric Pain and Palliative Care Program; University of California, Los Angeles

Study Officials

  • Lonnie K. Zeltzer, MD

    UCLA Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences

Study Record Dates

First Submitted

April 27, 2010

First Posted

May 7, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 30, 2016

Results First Posted

March 9, 2016

Record last verified: 2016-08

Locations