Preventing Substance Use Among Youth

September 17, 2024 updated by: Andria B Eisman, Wayne State University

Preventing Substance Use Among Youth: Behavioral and Economic Impact of Enhanced Implementation Strategies for Communities

Using a 2-group, mixed method group randomized trial design, this pilot study will compare standard implementation versus Enhanced Replicating Effective Programs (Enhanced REP) to deliver Michigan Model for Health (MMH) in Michigan high schools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Drug use remains a major public health problem among youth in the United States. Effective implementation of evidence-based interventions for youth is critical for reducing the burden of drug use and its consequences. The Michigan Model for Health (MMH) is an intervention that has demonstrated efficacy in reducing adolescent substance use. Yet, youth rarely receive evidence-based interventions (EBIs) as intended; this is, in part, due to a poor fit between the intervention and the context. The disconnect between the EBI and context is especially pronounced among underserved and vulnerable populations, including among youth exposed to trauma. Trauma is a potent risk factor for substance use, abuse, and the development of substance use disorders. Consequently, we have a critical need to design and test effective, cost-efficient implementation strategies to optimize the fidelity of school-based drug use prevention to better meet the needs of youth exposed to trauma. The objective of this study is to design and test a multi-component implementation strategy to improve intervention-context fit and enhance fidelity and effectiveness.

Methods: Using a 2-group, mixed method, randomized trial design, this pilot study will compare standard implementation (Replicating Effective Programs: REP) versus enhanced Enhanced Replicating Effective Programs (Enhanced REP) to deliver MMH. REP is a previously established implementation strategy that promotes EBI fidelity through a combination of curriculum packaging, training, and as-needed technical assistance. Enhanced REP incorporates tailoring of the EBI package and training and deploys customized implementation support (i.e., implementation facilitation).

This research designs and tests an implementation strategy deployed to systematically enhance the fit between the intervention and the context for a universal drug use prevention curriculum. The proposed research will focus on youth at heightened risk of drug use and its consequences due to trauma exposure. The proposed research is significant because of its potential to have a positive public health impact by preventing and reducing youth drug use and its consequences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
825

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Schools which fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to MMH implementation

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard MMH Curriculum Implementation
Teachers will receive the MMH curriculum manual, standard training and as-needed technical assistance, provided to them by the health coordinators; consistent with standard REP.
Behavioral: Standard implementation
The standard implementation of the Michigan Model for Health is consistent with Standard REP and includes the curriculum materials, standard training, and as-needed technical assistance.
Other Names:
  • Standard REP
Experimental: Enhanced Replicating Effective Programs (REP)
We will deploy Enhanced REP to include additional tailoring of the MMH curriculum to include trauma-informed approaches, tailored trauma-focused curriculum training, and implementation facilitation, ongoing specialized implementation support.
Behavioral: Enhanced Replicating Effective Programs (Enhanced REP)
Enhanced REP includes 1. a tailored MMH curriculum, 2. tailored training, and 3. ongoing provider consultation or facilitation to support implementation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Indicators of Feasibility
Time Frame: 9 months

To evaluate comprehensively curriculum feasibility, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH.

We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data.

The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).
9 months
Indicators of Acceptability
Time Frame: 9 months

To evaluate comprehensively curriculum acceptability, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH.

We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data.

The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).
9 months
Indicators of Appropriateness
Time Frame: 9 months

To evaluate comprehensively curriculum appropriateness, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH.

We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data.

The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).
9 months
Incremental Implementation Strategy Cost
Time Frame: 9 months
We used an activity-based micro-costing approach mapping key activities of Enhanced REP across implementation phases. We used the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework to guide implementation phases and to guide the determination of implementation strategy costs. To accurately assess the time spent on each activity, and therefore the cost, individuals (health coordinators and research staff) recorded time spent on tasks throughout the strategy deployment and documented those activities using an activity log. Because the cost of Enhanced REP is on top of the current practices of Standard REP, we report the incremental cost of Enhanced REP.
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Substance Use
Time Frame: 9 months
The investigators will assess past substance use using items from Monitoring the Future (MTF) with adapted response options and timeframe.
9 months
Student Engagement
Time Frame: 9 months
The investigators will assess student engagement using student satisfaction and key intervention skills. The satisfaction measure will be adapted based on a scale developed by Giles et al. for another drug prevention intervention with good psychometric properties that will include 4 items. The investigators will evaluate key intervention skills: assertive communication, refusal skills, and decision making. These dimensions are identified in the curriculum summative evaluation materials identified by the MMH curriculum and assessed in previous MMH studies and based on National Health Education Standards. The current study will assess secondary behavioral outcomes including poly-drug use using an item from the National Survey on Drug Use and Health (NSDUH). Substance use consequences (e.g., missed school due to substance use) will be ascertained using items from the Problem Oriented Screening Instrument for Teenagers.
9 months
Dose Delivered
Time Frame: 9 months
The investigators will assess dose or amount of program delivered using a curriculum fidelity tracking from. Teachers will be asked to complete a brief form following each lesson/unit included in the study. These units/lessons include the alcohol, tobacco and other drug prevention unit, the skills unit, and the social and emotional learning unit. The investigators will assess dose delivered by calculating the total number of lessons completed within each unit (10 lessons/unit). As part of the tracking form, teachers will report any adaptations or modifications, guided by the framework proposed by Wiltsey-Stirman et.al. This includes adding, removing and changing content, substituting activities and changing activity formats.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-20-10-2821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

From NIH HEAL (Helping to End Addiction Long-term) Public Access and Data Sharing (https://heal.nih.gov/about/public-access-data) information: Electronic copies of publications will be deposited within 4 weeks of acceptance by a journal in PubMed Central with proper metadata to be discoverable and accessible upon publication. Publications will be published under the Creative Commons Attribution 4.0 Generic License (CC BY 4.0) or otherwise dedicated to the public domain. Publications will be made publicly available immediately without an embargo period. Underlying Primary Data for the Publications will be made available through an suitable data repository, such as the NIH HEAL central data repository. To meet program goals, NIH requires broad sharing of Underlying Primary Data from NIH-Supported NIH HEAL Initiative Research Projects in a way that is responsive to concerns about protecting confidential and proprietary data and is consistent with other applicable laws and regulations.

IPD Sharing Time Frame

De-identified primary participant (i.e., student) -level data will be available through an appropriate data repository, such as the NIH HEAL Initiative central data repository. The data will be available upon acceptance for publication of the main findings from the final student-level dataset. Data will be available in the NIH HEAL repository per HEAL guidelines.

IPD Sharing Access Criteria

Access criteria will be determined by the NIH HEAL guidelines. Access to individual-level data will require entering into a data-sharing agreement that includes requirements to protect participants' privacy and data confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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