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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Counselor Training Methods
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.
Other: Counselor Training Methods

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheidow Consulting, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oregon Social Learning Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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