Substance Abuse ProblemCM-TSSNCT02740881
Web-Based Contingency Management Training for Addictions
A study testing Counselor Training Methods in people with Substance Abuse Problem, run by Sheidow Consulting, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Problem
- What is being tested?
- Counselor Training Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded if they are not professional counselors
- Younger than age 22
- Do not work in outpatient substance abuse treatment agencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Abuse Problem
- Being tested
- Counselor Training Methods
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselor Training MethodsOther
| Study group | Role | What they receive |
|---|---|---|
| Training Support System | Experimental | 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. Receives: Other: Counselor Training Methods |
| CM-CAT then TSS | Active comparator | 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. Receives: Other: Counselor Training Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of training support on outpatient counselor fidelity to Contingency Management Substance Abuse Treatment Model measured using CM Therapist Adherence Measure (CM-TAM)
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.
Measured: 15 months
Impact of training support on outpatient counselor fidelity to Contingency Management Substance Abuse Treatment Model measured using session tape review and scoring
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.
Measured: 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)
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.
Measured: 15 Months
Impact of training support on outpatient counselor fidelity to Contingency Management Substance Abuse Treatment Model measured using treatment outcomes.
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.
Measured: 15 Months
Impact of training support on client satisfaction with treatment.
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.
Measured: 15 months
Assessment of Counselor Training Satisfaction with Satisfaction Survey administration.
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.
Measured: 15 months
Assessment of Counselor Satisfaction with Training and Training Support with Focus Group Outcomes
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startNov 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheidow Consulting, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Social Learning Center
- Responsible party
- Principal investigator, Jaime Mulligan, Sheidow Consulting, Inc.
- Investigators
- Jaime Mulligan, Psy.D., Principal investigator, Sheidow Consulting, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740881
- Sponsor's protocol ID
- R44DA033745
- Acronym
- CM-TSS
- Status last verified
- Dec 2018
- First submitted
- 25 Nov 2015
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Training Support System for Community-Based Substance Abuse Agencies
- ClinicalTrials.gov ID
- NCT02740881
- Acronym / sponsor ID
- CM-TSS / R44DA033745
- Conditions
- Substance Abuse Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sheidow Consulting, Inc.University, hospital or other
- Collaborators
- Oregon Social Learning Center
- Study start
- Nov 2015
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Support System | Experimental | Other: Counselor Training MethodsParticipants 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. |
| CM-CAT then TSS | Active comparator | Other: Counselor Training MethodsParticipants 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants will be excluded if they are not professional counselors
- Younger than age 22
- Do not work in outpatient substance abuse treatment agencies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselor Training Methods | Other | CM-CAT then TSS, Training Support System |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Mulligan, Psy.D. principal investigator
Sheidow Consulting, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselor Training Methods in people with Substance Abuse Problem, run by Sheidow Consulting, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.