Substance AbuseCV-ATODNCT03084406
Efficacy of Centervention-ATOD: An Implementation Tool for Dissemination of Evidence-based Programs for Substance Abuse
A study testing Centervention-ATOD (CV-ATOD) in people with Substance Abuse, run by 3-C Institute for Social Development at 1 site in United States.
Trial summary
The pilot test of Centervention-ATOD, a customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings, will evaluate whether the product awards additive benefits in provider implementation proficiency and efficacy… Read more about this study
- Who is it for?
- Ages 11 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Centervention-ATOD (CV-ATOD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 22 Dec 2017
- 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 11 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Licensed CMH Provider to youth between ages 14 -17 for Free Talk EI/TAU
- Students enrolled in local University Clinical Programs for CHOICE EI/TAU
- Between ages 14 -17 for Free Talk EI/TAU, Between ages 11 -14 for CHOICE EI/TAU
- For Free Talk EI/TAU, youth may have experimented with or currently use alcohol or other drugs.
- For CHOICE EI/TAU, youth may, or may not, have considered ATOD experimentation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web-Based Tool for the Dissemination of Evidence-based Interventions for ATOD
The pilot test of Centervention-ATOD, a customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings, will evaluate whether the product awards additive benefits in provider implementation proficiency and efficacy, quality of implementation delivery, and EBP (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods. Additionally, a cost-effectiveness study will be conducted to assess whether the implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than traditional implementation methods.
Read the detailed description
Alcohol, tobacco, and other drug (ATOD) use among adolescents is a major public health problem with devastating personal, familial, and societal costs. Substance use in youth is associated with increased accidental injuries (including overdoses), psychiatric comorbidities, suicidality, school problems, juvenile delinquency, social and family problems, sexual impulsivity, and health consequences.A burgeoning neuroscience literature demonstrates ATOD use in youth is associated with a host of negative and potentially long-term sequelae, including alterations in brain structure, function, and neurocognition. Moreover, drug use in adolescence is the best predictor of abuse in adulthood; data published by the National Center on Addiction and Substance Abuse reveal that 90% of adults who meet substance dependence criteria began using alcohol and drugs during adolescence. In the U.S., the economic impact of substance abuse is staggering: in 2005, federal, state, and local governments spent a combined $467 billion on the direct and indirect costs associated with addiction, rendering substance dependence the largest, costliest, and most preventable public health problem in the U.S. today.
Over the past few decades, significant progress has been made in the field of ATOD research in developing evidence-based practices (EBPs), with research demonstrating ATOD users who receive research-proven treatments are nearly 2.5 times more likely to achieve clinically significant post-treatment abstinence compared to those receiving non-evidence-based treatment. However, despite availability, EBPs are rarely adopted for use in everyday service settings. Further, even when adopted, considerable variation exists both in the quality with which EBPs are implemented and their long-term sustainability. Furthering our understanding of how efficacious treatment programs can be successfully introduced into real-world treatment settings is key to bridging this research-to-practice gap.
The pilot test of Centervention-ATOD, a customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings, will evaluate whether the product awards additive benefits in provider implementation proficiency and efficacy, quality of implementation delivery, and EBP (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods. Additionally, a cost-effectiveness study will be conducted to assess whether the implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than traditional implementation methods.
The pilot test will employ a Hybrid Type II study design[14] to simultaneously test the clinical evidence-based program as well as the implementation strategy. Regardless of the EBP implemented, 110 mental health (MH) providers will be randomly assigned to one of two conditions: (1) Enhanced implementation (EI) or (2) Implementation as Usual (IAU). Providers will either implement (a) Free Talk, a motivational interviewing group intervention with 5-8 youth per group over a six-week period or (b) CHOICE, a motivational interviewing group prevention program with 5-8 youth per group over a five-week period. Participating youth between ages 14-17 who may have experimented with alcohol or other drugs (AOD) will participate in the Free Talk intervention while youth between ages 11-15 who may or may not have used any substances will participate in the CHOICE prevention program. At the conclusion of the pilot test, a study of cost-effectiveness of the implementation support strategy (i.e., Centervention-ATOD) will be conducted with agency administrators of participating providers.
- Conditions
- Substance Abuse
- Being tested
- Centervention-ATOD (CV-ATOD)
- Keywords
- Substance Abuse, Implementation Science, Evidence-based Practices
- 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.
Centervention-ATOD (CV-ATOD)Other
A customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Implementation (EI) | Experimental | Providers in the Free Talk EI condition will receive access to CV-ATOD. They will participate in an online training course that mirrors the training in the IAU condition. EI providers will also receive access to interactive online exercises and practice activities within the training module. They will have online access to the Free Talk: Group MI for Teens searchable manual and materials via CV-ATOD. Providers may complete an optional CE course following the completion of the training module. EI providers will have access to all EBP implementation tools provided by CV-ATOD. Student providers in the CHOICE EI condition will receive access to CV-ATOD. They will participate in an online training course that mirrors the training in the IAU condition. However, EI providers will also receive access to interactive online exercises and practice activities within the training module. They will have online access to the CHOICE: Group MI for Teens searchable manual and materials via CV-ATOD. Receives: Other: Centervention-ATOD (CV-ATOD) |
| Implementation As Usual (IAU) | No intervention | CMH providers in the Free Talk IAU condition will receive access to the Group MI for Teens website that provides asynchronous, self-paced training videos as well as downloadable intervention materials and resources. CMH providers in this condition are only required to watch the first two training videos before receiving access to download the Free Talk training manual and materials. Providers may also complete an optional CE course following the completion of all training videos. Student providers in the CHOICE IAU condition will receive access to the Group MI for Teens website that provides online training videos as well as downloadable intervention materials and resources. IAU providers are only required to watch the first two training videos before receiving access to download the CHOICE training manual and materials. Providers may also complete an optional EBP knowledge test following the completion of all training videos. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Provider EBP knowledge and MI skills
Providers will take an EBP knowledge and MI skills test of 25 questions from a bank of questions produced by the EBP developer.
Measured: 1) prior to starting the trial (baseline) but after completing the training for the EBP and the ISS 2) within two weeks of completing the last session of the EBP
Change In Provider Self-Efficacy for EBP Implementation
Providers will report their self-efficacy regarding EBP implementation. Ten items from two subscales (change commitment, change efficacy) of the Readiness for Change instrument (Shea et al.) will be used to measure self-efficacy to implement the EBP.
Measured: 1) prior to starting the trial (baseline) but after completing the training for the EBP and the ISS 2) within two weeks of completing the last session of the EBP
Provider Fidelity to EBP - Component Coverage
Providers will report on their component coverage after each session during the 5 or 6 weeks of the program trial by indicating for each component whether it was fully completed, partially completed, or not completed.
Measured: during the 5 or 6 week EBP trial, after each session is completed
Provider Fidelity to EBP - MI Quality of Delivery
Providers will report on their MI quality of delivery after each session during the 5 or 6 weeks of the program trial by completing a 10-item MI Self-Assessment questionnaire from the MIA Step Manual (NIDA/SAMHSA).
Measured: during the 5 or 6 week EBP trial, after each session is completed
Provider Fidelity to EBP - Participant Responsiveness
Providers will report on participant responsiveness after every session during the 5 or 6 weeks of the program trial by completing a 6-item questionnaire measuring youth engagement.
Measured: during the 5 or 6 week EBP trial, after each session is completed
Provider Perceptions of EBP - Usage Rating
Providers will report on their perceptions of the EBP by completing 26 items from the revised Usage Rating Profile-Intervention (URPI-R) that will measure: (a) acceptability, (b) understanding, (c) feasibility, (d) system climate, and (e) system support.
Measured: within two weeks after completing the last session of the EBP
Provider Perceptions of EBP - Appropriateness
Providers will report on their perceptions of the EBP by completing eight items from the Training/Practice Acceptability/Feasibility/Appropriateness Scale (TPA) measuring appropriateness.
Measured: within two weeks after completing the last session of the EBP
Provider Perceptions of EBP - Adoption
Providers will report on their EBP usage and adoption by completing the result demonstrability subscale from the Adoption of an IT innovation (AITI).
Measured: within two weeks after completing the last session of the EBP
Change in Youth Beliefs, Attitudes toward Substance Use
Youth will report on their attitudes and beliefs toward substance use by completing questions obtained from the EBP developer. These questions will assess: (a) beliefs and attitudes, (b) perceived benefits, (c) perceived normative substance use, (d) intention to use in the future, (e) youth motivation, and (f) readiness to change.
Measured: 1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Change in Youth Substance Use
Youth will report on their substance use by completing questions obtained from the EBP developer. These questions will assess: a) last 30 days use, b) negative consequences due to substance use, c) intention to use in the future, d) resistance self-efficacy, and e) coping strategies.
Measured: 1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Secondary outcomes (7)
Provider Fidelity to ISS
The system will collect usage data throughout the trial to document when and how the website and software are being used. Whenever providers access the ISS, information about that interaction will be captured. Usage statistics will be collected via a combination of HTTP access logs and session cookies to document the number of times a given webpagevideo//tool/resource is accessed.
Measured: during training and during the 5 or 6 week EBP trial as providers use the ISS
Provider Perceptions of ISS - Usage Rating
Providers will report on their perceptions of the ISS by completing 26 items from the revised Usage Rating Profile-Intervention (URPI-R) that will measure: (a) acceptability, (b) understanding, (c) feasibility, (d) system climate, and (e) system support.
Providers will report on their experiences with the ISS and their intent to use it beyond this study.
Measured: within two weeks of completing the last session of the EBP
Provider Perceptions of ISS - Appropriateness
Providers will report on their perceptions of the ISS by completing eight items from the Training/Practice Acceptability/Feasibility/Appropriateness Scale (TPA) measuring appropriateness.
Measured: within two weeks of completing the last session of the EBP
Provider Perceptions of ISS - Adoption
Providers will report on their ISS usage and adoption by completing the result demonstrability subscale from the Adoption of an IT innovation (AITI).
Measured: within two weeks after completing the last session of the EBP
Provider Perceptions of ISS Characteristics - System Usability
Providers will report on the ISS characteristics by completing the Post-Study System Usability Questionnaire (PSSUQ) to assess: a) information quality, b) interface quality, and c) endorsement, and d) overall satisfaction with the ISS.
Measured: within two weeks of completing the last session of the EBP
Provider Perceptions of ISS Characteristics - Components Usability
Providers will report on the ISS characteristics by completing the After Scenario Questionnaire (ASQ) to assess satisfaction and ease of use of each feature and component of the ISS (training resources, goal setting, fidelity, progress monitoring, implementation supports, and outcomes).
Measured: within two weeks of completing the last session of the EBP
Cost Effectiveness of EBP with Centervention as the ISS
To measure cost effectiveness, the brief Drug Abuse Treatment Cost Analysis Program (DATCAP) consisting of approximately 40 questions will be used to assess the cost of implementing a substance use EBP using Centervention as the ISS. Agency administrators will report via a phone interview costs associated with different aspects of traditional substance use EBP implementation at their agency.
Measured: within 6-months of providers completing the last session of the FreeTalk EBP only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start13 Feb 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The pilot test will employ a Hybrid Type II study design to simultaneously test the clinical evidence-based program as well as the implementation strategy.
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa E DeRosier, PhD, Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084406
- Sponsor's protocol ID
- R44DA035014
- Acronym
- CV-ATOD
- Status last verified
- Oct 2018
- First submitted
- 2 Mar 2017
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Tool for the Dissemination of Evidence-based Interventions for ATOD
- ClinicalTrials.gov ID
- NCT03084406
- Acronym / sponsor ID
- CV-ATOD / R44DA035014
- Conditions
- Substance Abuse
- Keywords
- Substance Abuse, Implementation Science, Evidence-based Practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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.
The pilot test of Centervention-ATOD, a customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings, will evaluate whether the product awards additive benefits in provider implementation proficiency and efficacy, quality of implementation delivery, and EBP (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods. Additionally, a cost-effectiveness study will be conducted to assess whether the implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than traditional implementation methods.
Detailed description
Alcohol, tobacco, and other drug (ATOD) use among adolescents is a major public health problem with devastating personal, familial, and societal costs. Substance use in youth is associated with increased accidental injuries (including overdoses), psychiatric comorbidities, suicidality, school problems, juvenile delinquency, social and family problems, sexual impulsivity, and health consequences.A burgeoning neuroscience literature demonstrates ATOD use in youth is associated with a host of negative and potentially long-term sequelae, including alterations in brain structure, function, and neurocognition. Moreover, drug use in adolescence is the best predictor of abuse in adulthood; data published by the National Center on Addiction and Substance Abuse reveal that 90% of adults who meet substance dependence criteria began using alcohol and drugs during adolescence. In the U.S., the economic impact of substance abuse is staggering: in 2005, federal, state, and local governments spent a combined $467 billion on the direct and indirect costs associated with addiction, rendering substance dependence the largest, costliest, and most preventable public health problem in the U.S. today.
Over the past few decades, significant progress has been made in the field of ATOD research in developing evidence-based practices (EBPs), with research demonstrating ATOD users who receive research-proven treatments are nearly 2.5 times more likely to achieve clinically significant post-treatment abstinence compared to those receiving non-evidence-based treatment. However, despite availability, EBPs are rarely adopted for use in everyday service settings. Further, even when adopted, considerable variation exists both in the quality with which EBPs are implemented and their long-term sustainability. Furthering our understanding of how efficacious treatment programs can be successfully introduced into real-world treatment settings is key to bridging this research-to-practice gap.
The pilot test of Centervention-ATOD, a customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings, will evaluate whether the product awards additive benefits in provider implementation proficiency and efficacy, quality of implementation delivery, and EBP (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods. Additionally, a cost-effectiveness study will be conducted to assess whether the implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than traditional implementation methods.
The pilot test will employ a Hybrid Type II study design[14] to simultaneously test the clinical evidence-based program as well as the implementation strategy. Regardless of the EBP implemented, 110 mental health (MH) providers will be randomly assigned to one of two conditions: (1) Enhanced implementation (EI) or (2) Implementation as Usual (IAU). Providers will either implement (a) Free Talk, a motivational interviewing group intervention with 5-8 youth per group over a six-week period or (b) CHOICE, a motivational interviewing group prevention program with 5-8 youth per group over a five-week period. Participating youth between ages 14-17 who may have experimented with alcohol or other drugs (AOD) will participate in the Free Talk intervention while youth between ages 11-15 who may or may not have used any substances will participate in the CHOICE prevention program. At the conclusion of the pilot test, a study of cost-effectiveness of the implementation support strategy (i.e., Centervention-ATOD) will be conducted with agency administrators of participating providers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The pilot test will employ a Hybrid Type II study design to simultaneously test the clinical evidence-based program as well as the implementation strategy.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Implementation (EI) | Experimental | Other: Centervention-ATOD (CV-ATOD)Providers in the Free Talk EI condition will receive access to CV-ATOD. They will participate in an online training course that mirrors the training in the IAU condition. EI providers will also receive access to interactive online exercises and practice activities within the training module. They will have online access to the Free Talk: Group MI for Teens searchable manual and materials via CV-ATOD. Providers may complete an optional CE course following the completion of the training module. EI providers will have access to all EBP implementation tools provided by CV-ATOD. Student providers in the CHOICE EI condition will receive access to CV-ATOD. They will participate in an online training course that mirrors the training in the IAU condition. However, EI providers will also receive access to interactive online exercises and practice activities within the training module. They will have online access to the CHOICE: Group MI for Teens searchable manual and materials via CV-ATOD. |
| Implementation As Usual (IAU) | No intervention | –CMH providers in the Free Talk IAU condition will receive access to the Group MI for Teens website that provides asynchronous, self-paced training videos as well as downloadable intervention materials and resources. CMH providers in this condition are only required to watch the first two training videos before receiving access to download the Free Talk training manual and materials. Providers may also complete an optional CE course following the completion of all training videos. Student providers in the CHOICE IAU condition will receive access to the Group MI for Teens website that provides online training videos as well as downloadable intervention materials and resources. IAU providers are only required to watch the first two training videos before receiving access to download the CHOICE training manual and materials. Providers may also complete an optional EBP knowledge test following the completion of all training videos. |
Who may qualify
- Ages
- 11 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Licensed CMH Provider to youth between ages 14 -17 for Free Talk EI/TAU
- Students enrolled in local University Clinical Programs for CHOICE EI/TAU
- Between ages 14 -17 for Free Talk EI/TAU, Between ages 11 -14 for CHOICE EI/TAU
- For Free Talk EI/TAU, youth may have experimented with or currently use alcohol or other drugs.
- For CHOICE EI/TAU, youth may, or may not, have considered ATOD experimentation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Centervention-ATOD (CV-ATOD)A customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings. | Other | Enhanced Implementation (EI) |
Primary outcome
Change in Provider EBP knowledge and MI skills
Time frame: 1) prior to starting the trial (baseline) but after completing the training for the EBP and the ISS 2) within two weeks of completing the last session of the EBP
Providers will take an EBP knowledge and MI skills test of 25 questions from a bank of questions produced by the EBP developer.
Change In Provider Self-Efficacy for EBP Implementation
Time frame: 1) prior to starting the trial (baseline) but after completing the training for the EBP and the ISS 2) within two weeks of completing the last session of the EBP
Providers will report their self-efficacy regarding EBP implementation. Ten items from two subscales (change commitment, change efficacy) of the Readiness for Change instrument (Shea et al.) will be used to measure self-efficacy to implement the EBP.
Provider Fidelity to EBP - Component Coverage
Time frame: during the 5 or 6 week EBP trial, after each session is completed
Providers will report on their component coverage after each session during the 5 or 6 weeks of the program trial by indicating for each component whether it was fully completed, partially completed, or not completed.
Provider Fidelity to EBP - MI Quality of Delivery
Time frame: during the 5 or 6 week EBP trial, after each session is completed
Providers will report on their MI quality of delivery after each session during the 5 or 6 weeks of the program trial by completing a 10-item MI Self-Assessment questionnaire from the MIA Step Manual (NIDA/SAMHSA).
Provider Fidelity to EBP - Participant Responsiveness
Time frame: during the 5 or 6 week EBP trial, after each session is completed
Providers will report on participant responsiveness after every session during the 5 or 6 weeks of the program trial by completing a 6-item questionnaire measuring youth engagement.
Provider Perceptions of EBP - Usage Rating
Time frame: within two weeks after completing the last session of the EBP
Providers will report on their perceptions of the EBP by completing 26 items from the revised Usage Rating Profile-Intervention (URPI-R) that will measure: (a) acceptability, (b) understanding, (c) feasibility, (d) system climate, and (e) system support.
Provider Perceptions of EBP - Appropriateness
Time frame: within two weeks after completing the last session of the EBP
Providers will report on their perceptions of the EBP by completing eight items from the Training/Practice Acceptability/Feasibility/Appropriateness Scale (TPA) measuring appropriateness.
Provider Perceptions of EBP - Adoption
Time frame: within two weeks after completing the last session of the EBP
Providers will report on their EBP usage and adoption by completing the result demonstrability subscale from the Adoption of an IT innovation (AITI).
Change in Youth Beliefs, Attitudes toward Substance Use
Time frame: 1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Youth will report on their attitudes and beliefs toward substance use by completing questions obtained from the EBP developer. These questions will assess: (a) beliefs and attitudes, (b) perceived benefits, (c) perceived normative substance use, (d) intention to use in the future, (e) youth motivation, and (f) readiness to change.
Change in Youth Substance Use
Time frame: 1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Youth will report on their substance use by completing questions obtained from the EBP developer. These questions will assess: a) last 30 days use, b) negative consequences due to substance use, c) intention to use in the future, d) resistance self-efficacy, and e) coping strategies.
7 secondary outcomes
Provider Fidelity to ISS
Time frame: during training and during the 5 or 6 week EBP trial as providers use the ISS
Provider Perceptions of ISS - Usage Rating
Time frame: within two weeks of completing the last session of the EBP
Provider Perceptions of ISS - Appropriateness
Time frame: within two weeks of completing the last session of the EBP
Provider Perceptions of ISS - Adoption
Time frame: within two weeks after completing the last session of the EBP
Provider Perceptions of ISS Characteristics - System Usability
Time frame: within two weeks of completing the last session of the EBP
Provider Perceptions of ISS Characteristics - Components Usability
Time frame: within two weeks of completing the last session of the EBP
Cost Effectiveness of EBP with Centervention as the ISS
Time frame: within 6-months of providers completing the last session of the FreeTalk EBP only
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 1 Nov 2018.
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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.
Melissa E DeRosier, PhD principal investigator
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centervention-ATOD (CV-ATOD) in people with Substance Abuse, run by 3-C Institute for Social Development 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 5 inclusion and 0 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 1 Nov 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?
Change in Provider EBP knowledge and MI skills (time frame: 1) prior to starting the trial (baseline) but after completing the training for the EBP and the ISS 2) within two weeks of completing the last session of the EBP). The study lists 10 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 1 Nov 2018.