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Clinical Trials/NCT03084406
NCT03084406
Completed
Not Applicable

Web-Based Tool for the Dissemination of Evidence-based Interventions for ATOD

3-C Institute for Social Development1 site in 1 country327 target enrollmentFebruary 13, 2017
ConditionsSubstance Abuse

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Abuse
Sponsor
3-C Institute for Social Development
Enrollment
327
Locations
1
Primary Endpoint
Change In Provider Self-Efficacy for EBP Implementation
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2017
End Date
December 22, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
3-C Institute for Social Development
Responsible Party
Sponsor

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 - 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 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.

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.

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 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 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.

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.

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.

Secondary Outcomes

  • Provider Perceptions of ISS - Usage Rating(within two weeks of completing the last session of the EBP)
  • Provider Fidelity to ISS(during training and during the 5 or 6 week EBP trial as providers use the ISS)
  • Provider Perceptions of ISS - Adoption(within two weeks after completing the last session of the EBP)
  • Provider Perceptions of ISS - Appropriateness(within two weeks of completing the last session of the EBP)
  • Cost Effectiveness of EBP with Centervention as the ISS(within 6-months of providers completing the last session of the FreeTalk EBP only)
  • Provider Perceptions of ISS Characteristics - System Usability(within two weeks of completing the last session of the EBP)
  • Provider Perceptions of ISS Characteristics - Components Usability(within two weeks of completing the last session of the EBP)

Study Sites (1)

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