Clinical trial NCT03084406: Efficacy of Centervention-ATOD: An Implementation Tool for Dissemination of Evidence-based Programs for Substance Abuse
Official title: Web-Based Tool for the Dissemination of Evidence-based Interventions for ATOD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Substance Abuse
Implementation Science
Evidence-based Practices
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 327
Sex: ALL
Minimum age (years): 11
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in Provider EBP knowledge and MI skills
timeFrame: 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
measure: Change In Provider Self-Efficacy for EBP Implementation
timeFrame: 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
measure: Provider Fidelity to EBP - Component Coverage
timeFrame: during the 5 or 6 week EBP trial, after each session is completed
measure: Provider Fidelity to EBP - MI Quality of Delivery
timeFrame: during the 5 or 6 week EBP trial, after each session is completed
measure: Provider Fidelity to EBP - Participant Responsiveness
timeFrame: during the 5 or 6 week EBP trial, after each session is completed
measure: Provider Perceptions of EBP - Usage Rating
timeFrame: within two weeks after completing the last session of the EBP
measure: Provider Perceptions of EBP - Appropriateness
timeFrame: within two weeks after completing the last session of the EBP
measure: Provider Perceptions of EBP - Adoption
timeFrame: within two weeks after completing the last session of the EBP
measure: Change in Youth Beliefs, Attitudes toward Substance Use
timeFrame: 1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
measure: Change in Youth Substance Use
timeFrame: 1) prior to starting the trial (baseline) 2) within two weeks after completing the last session of the EBP.
Secondary outcomes:
measure: Provider Fidelity to ISS
timeFrame: during training and during the 5 or 6 week EBP trial as providers use the ISS
measure: Provider Perceptions of ISS - Usage Rating
timeFrame: within two weeks of completing the last session of the EBP
measure: Provider Perceptions of ISS - Appropriateness
timeFrame: within two weeks of completing the last session of the EBP
measure: Provider Perceptions of ISS - Adoption
timeFrame: within two weeks after completing the last session of the EBP
measure: Provider Perceptions of ISS Characteristics - System Usability
timeFrame: within two weeks of completing the last session of the EBP
measure: Provider Perceptions of ISS Characteristics - Components Usability
timeFrame: within two weeks of completing the last session of the EBP
measure: Cost Effectiveness of EBP with Centervention as the ISS
timeFrame: within 6-months of providers completing the last session of the FreeTalk EBP only
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: CEO
name: Melissa E DeRosier, PhD
role: PRINCIPAL_INVESTIGATOR
References: