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Efficacy of Centervention-ATOD: An Implementation Tool for Dissemination of Evidence-based Programs for Substance Abuse (CV-ATOD)

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Centervention-ATOD (CV-ATOD)
Sponsored by
3-C Institute for Social Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Abuse focused on measuring Substance Abuse, Implementation Science, Evidence-based Practices

Eligibility Criteria

11 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Community Mental Health (CMH) Providers

  • 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

Inclusion Criteria: Youth

  • 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.

Sites / Locations

  • 3C Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Implementation (EI)

Implementation As Usual (IAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.
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.
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.
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).
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.
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.

Secondary Outcome Measures

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.
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.
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.
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).
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.
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).
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.

Full Information

First Posted
March 2, 2017
Last Updated
October 31, 2018
Sponsor
3-C Institute for Social Development
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1. Study Identification

Unique Protocol Identification Number
NCT03084406
Brief Title
Efficacy of Centervention-ATOD: An Implementation Tool for Dissemination of Evidence-based Programs for Substance Abuse
Acronym
CV-ATOD
Official Title
Web-Based Tool for the Dissemination of Evidence-based Interventions for ATOD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3-C Institute for Social Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance Abuse, Implementation Science, Evidence-based Practices

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Implementation (EI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Implementation As Usual (IAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Centervention-ATOD (CV-ATOD)
Intervention Description
A customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings.
Primary Outcome Measure Information:
Title
Change in Provider EBP knowledge and MI skills
Description
Providers will take an EBP knowledge and MI skills test of 25 questions from a bank of questions produced by the EBP developer.
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
Title
Change In Provider Self-Efficacy for EBP Implementation
Description
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.
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
Title
Provider Fidelity to EBP - Component Coverage
Description
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.
Time Frame
during the 5 or 6 week EBP trial, after each session is completed
Title
Provider Fidelity to EBP - MI Quality of Delivery
Description
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).
Time Frame
during the 5 or 6 week EBP trial, after each session is completed
Title
Provider Fidelity to EBP - Participant Responsiveness
Description
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.
Time Frame
during the 5 or 6 week EBP trial, after each session is completed
Title
Provider Perceptions of EBP - Usage Rating
Description
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.
Time Frame
within two weeks after completing the last session of the EBP
Title
Provider Perceptions of EBP - Appropriateness
Description
Providers will report on their perceptions of the EBP by completing eight items from the Training/Practice Acceptability/Feasibility/Appropriateness Scale (TPA) measuring appropriateness.
Time Frame
within two weeks after completing the last session of the EBP
Title
Provider Perceptions of EBP - Adoption
Description
Providers will report on their EBP usage and adoption by completing the result demonstrability subscale from the Adoption of an IT innovation (AITI).
Time Frame
within two weeks after completing the last session of the EBP
Title
Change in Youth Beliefs, Attitudes toward Substance Use
Description
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.
Time Frame
1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Title
Change in Youth Substance Use
Description
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.
Time Frame
1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Secondary Outcome Measure Information:
Title
Provider Fidelity to ISS
Description
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.
Time Frame
during training and during the 5 or 6 week EBP trial as providers use the ISS
Title
Provider Perceptions of ISS - Usage Rating
Description
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.
Time Frame
within two weeks of completing the last session of the EBP
Title
Provider Perceptions of ISS - Appropriateness
Description
Providers will report on their perceptions of the ISS by completing eight items from the Training/Practice Acceptability/Feasibility/Appropriateness Scale (TPA) measuring appropriateness.
Time Frame
within two weeks of completing the last session of the EBP
Title
Provider Perceptions of ISS - Adoption
Description
Providers will report on their ISS usage and adoption by completing the result demonstrability subscale from the Adoption of an IT innovation (AITI).
Time Frame
within two weeks after completing the last session of the EBP
Title
Provider Perceptions of ISS Characteristics - System Usability
Description
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.
Time Frame
within two weeks of completing the last session of the EBP
Title
Provider Perceptions of ISS Characteristics - Components Usability
Description
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).
Time Frame
within two weeks of completing the last session of the EBP
Title
Cost Effectiveness of EBP with Centervention as the ISS
Description
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.
Time Frame
within 6-months of providers completing the last session of the FreeTalk EBP only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Community Mental Health (CMH) Providers 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 Inclusion Criteria: Youth 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa E DeRosier, PhD
Organizational Affiliation
CEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
3C Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Centervention-ATOD: An Implementation Tool for Dissemination of Evidence-based Programs for Substance Abuse

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