NCT03084406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

March 2, 2017

Last Update Submit

October 31, 2018

Conditions

Keywords

Substance AbuseImplementation ScienceEvidence-based Practices

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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).

    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.

    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.

    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.

    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).

    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.

    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.

    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

    during training and during the 5 or 6 week EBP trial as providers use the ISS

  • Provider Perceptions of ISS - Usage Rating

    within two weeks of completing the last session of the EBP

  • Provider Perceptions of ISS - Appropriateness

    within two weeks of completing the last session of the EBP

  • Provider Perceptions of ISS - Adoption

    within two weeks after completing the last session of the EBP

  • Provider Perceptions of ISS Characteristics - System Usability

    within two weeks of completing the last session of the EBP

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

A customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings.

Enhanced Implementation (EI)

Eligibility Criteria

Age11 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Melissa E DeRosier, PhD

    CEO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 21, 2017

Study Start

February 13, 2017

Primary Completion

December 22, 2017

Study Completion

December 22, 2017

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations