- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02740881
Web-Based Contingency Management Training for Addictions (CM-TSS)
December 27, 2018 updated by: Jaime Mulligan, Sheidow Consulting, Inc.
Online Training Support System for Community-Based Substance Abuse Agencies
Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities and society (societal costs estimated at over $400 billion annually and greater than costs for any other health problem).
There is a clear public health need for improving and expanding the delivery of evidence-based treatments for adolescent substance use, but despite this clear need, there is a large divide between science and practice.
This project will develop a cost-effective, easily accessible, web-based Training Support System (TSS) for Contingency Management that incorporates ongoing training, feedback, and support provided to both counselors and their community-based agencies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Drug abusing and dependent youth represent a greatly under-served population at high risk of presenting significant deleterious long-term outcomes for themselves, their families, communities and society at extraordinary long-term costs.
Adolescent substance use has been linked to serious problems including automobile accidents, increased rates of risky sexual behavior which increases the youth's chances of contracting sexually transmitted diseases, high rates of physical and sexual abuse, and increased risk for school dropout.
Further, drug use during adolescence predicts decreased college involvement as well as direct links to unemployment and job instability in young adulthood.
In general, youth with substance use disorders represent a greatly under-served population in need of effective treatment; however, adolescents and their families seeking treatment are unlikely to receive an effective evidence-based intervention.
Given this, there is a clear public health need for improving and expanding the delivery of evidence-based treatments for adolescent substance use.
Despite this clear need, there is a large divide between science and practice.
The proposed project has the potential to overcome a gaping need within the outpatient treatment sector, which is the largest purveyor of adolescent substance use treatment in the country.
Specifically, the proposed SBIR Phase II project will commercialize a targeted internet-based Training Support System (TSS) which will make it possible for community-based agencies to adopt, implement, and sustain use of Contingency Management (CM), an evidence-based substance abuse treatment for adolescents and their families.
This system includes an initial computer assisted training for individual counselors, individual- and agency-level performance assessment and feedback processes, remediation training and support, organizational-level consultation on funding structures, and clinical expert guidance for counselors.
This entirely internet-based training and support system is the first of its kind.
It provides a cost-effective training and support platform for community-based substance abuse treatment providers, enabling them to train staff in an evidence-based practice with the necessary ongoing support to ensure fidelity and rapid uptake of the practice.
The Phase I aims focused on development of the TSS and initial pilot testing.
The Phase II project's first aim is to finalize development of the TSS based on data collected in the Phase I pilot testing.
These data-driven enhancements and changes will ensure high usability and commercialization potential of the TSS.
The project's second aim is to conduct a randomized trial evaluating the efficacy of the TSS in community-based settings, including qualitative evaluation of the TSS and quantitative evaluation of (a) counselor knowledge, adherence, and satisfaction and (b) clinical outcomes and client satisfaction.
Phase II will conclude with the development of a market-ready CM Training Support System for community-based counselors that will provide a cost-effective strategy for increasing the use of evidence-based interventions for youth who need them and rarely have access to them.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- Sheidow Consulting
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Professional counselors in outpatient substance abuse treatment agencies.
- Must treat adolescent substance abusers in clinic-based care.
- Counselors employed by these agencies are healthy, gainfully-employed individuals who are all adults with advanced degrees.
Exclusion Criteria:
- Participants will be excluded if they are not professional counselors
- Younger than age 22
- Do not work in outpatient substance abuse treatment agencies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training Support System
Participants receive training in Contingency Management and immediately receive the full training support system and quality assurance feedback for 15 months while they provide the treatment.
|
|
|
Active Comparator: CM-CAT then TSS
Participants are trained in Contingency Management and use the treatment without training support and quality assurance feedback for 9 months.
After 9 months they continue using Contingency Management but now receive the full training support system and quality assurance feedback for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of training support on outpatient counselor fidelity to Contingency Management Substance Abuse Treatment Model measured using CM Therapist Adherence Measure (CM-TAM)
Time Frame: 15 months
|
Impact of ongoing training and support on counselor fidelity to the Contingency Management treatment model will be measured through the administration of the Contingency Management Therapist Adherence Measure (CM-TAM), a 34 item paper and pencil survey, completed monthly through the duration of the study.
Scores on the CM-TAM indicate amount of counselor adherence to the treatment model.
|
15 months
|
|
Impact of training support on outpatient counselor fidelity to Contingency Management Substance Abuse Treatment Model measured using session tape review and scoring
Time Frame: 15 Months
|
Impact of ongoing training and support on counselor fidelity to the Contingency Management treatment model will be measured through the review and scoring of session audio tapes.
Scores generated through the session tape review indicate amount of counselor adherence to the treatment model and extent of treatment implementation.
|
15 Months
|
|
Impact of training support on outpatient counselor knowledge of, and fidelity to, the Contingency Management Substance Abuse Treatment Model measured using Contingency Management Knowledge Test (CM-KT)
Time Frame: 15 Months
|
Impact of ongoing training and support on counselor fidelity to the Contingency Management treatment model will be measured through the administration of the Contingency Management Knowledge Test (CM-KT), a brief multiple choice tests administered annually.
Scores from the CM-KT administrations summarize counselor knowledge changes over time.
|
15 Months
|
|
Impact of training support on outpatient counselor fidelity to Contingency Management Substance Abuse Treatment Model measured using treatment outcomes.
Time Frame: 15 Months
|
Impact of ongoing training and support on counselor fidelity to the Contingency Management treatment model and on treatment outcomes will be measured through the review of treatment outcomes.
|
15 Months
|
|
Impact of training support on client satisfaction with treatment.
Time Frame: 15 months
|
Impact of training support on client satisfaction with treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8), completed by each client at the end of treatment.
|
15 months
|
|
Assessment of Counselor Training Satisfaction with Satisfaction Survey administration.
Time Frame: 15 months
|
Counselor satisfaction with the training and training support will be measured using a counselor training satisfaction questionnaire.
Counselors will complete 3 training satisfaction surveys over the course of the study.
|
15 months
|
|
Assessment of Counselor Satisfaction with Training and Training Support with Focus Group Outcomes
Time Frame: 15 months
|
Counselor will participate in 2-3 focus groups (depending on condition assignment) over the course of the study.
Focus groups will be used to gather qualitative information about the counselor experience with the training and support strategies.
|
15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaime Mulligan, Psy.D., Sheidow Consulting, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
August 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
November 25, 2015
First Submitted That Met QC Criteria
April 12, 2016
First Posted (Estimate)
April 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 31, 2018
Last Update Submitted That Met QC Criteria
December 27, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44DA033745 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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