Randomized Trial of a Data-driven Technical Assistance System for Drug Prevention Coalitions

December 5, 2024 updated by: Louis D. Brown, The University of Texas Health Science Center, Houston
This project is designed to test the Coalition Check-Up (CCU)-a theory-based and data-driven technical assistance (TA) system that supports community coalitions' implementation of evidence-based programs (EBPs) for drug prevention. The primary aims of the project are to: 1) Estimate the impact of the CCU on coalition capacity. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition to evaluate whether the CCU improves coalition capacity as measured by coalition member reports of team processes, network composition, and collaborative structure. 2) Estimate the impact of the CCU on implementation of evidence-based programs. The study will test the hypothesis that coalitions receiving the CCU will implement EBPs with greater: a) quantity, b) quality, and c) sustainability. The study will also test coalition capacity as a mediator of CCU impact on EBP implementation. 3) Estimate the impact of the CCU on youth substance use. The study will test the hypothesis that communities receiving the CCU will reduce youth substance use relative to communities in the comparison condition. The study will also test EBP implementation as a mediator of CCU impact on youth substance use.

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

The overall goal of this five-year R01 study is to test the Coalition Check-Up (CCU) technical assistance (TA) system for supporting community coalitions' implementation of evidence-based drug prevention programs (EBPs). Over 5,000 community anti-drug coalitions operating in the U.S serve as a cornerstone of federal drug prevention. These coalitions, however, have only demonstrated efficacy in preventing substance use when they use TA and implement EBPs, a key research-to-practice gap. The CCU supports coalitions by identifying and addressing gaps in EBP implementation capacity. The proposed study advances implementation science by applying Wandersman's Interactive Systems Framework to test the effects of CCU on coalition EBP implementation capacity and youth outcomes. Despite the popularity of community anti-drug coalitions as a mechanism for EBP dissemination, scant research addresses how to support coalitions for optimal EBP implementation. Lacking adequate support, coalitions and EBPs often fail. Intensive TA provided in evidence-based coalition models is effective but often too expensive to scale in real-world settings. The CCU provides a lower-cost TA system that is broadly applicable across coalition models. The study's main objective is to test the overall effectiveness of the CCU, including how it contributes to EBP implementation and prevention of youth substance use. Building on the Interactive System Framework, the central hypothesis is that the CCU can enhance the prevention support system, thereby increasing coalition capacity for EBP implementation and the probability that EBPs will reduce youth substance use. The study will test this central hypothesis by pursuing three specific aims. The first aim is to estimate the impact of the CCU on coalition capacity, including team processes, network composition, and collaborative structure. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition. The second aim is to estimate the impact of the CCU on implementation of EBPs, including EBP reach, implementation quality, and sustainability. The third aim is to estimate the impact of the CCU on youth substance use, including alcohol, tobacco, marijuana, and opioids. The CCU is innovative in its emphasis on proactive monitoring and data-driven TA, its use of motivational interviewing to enhance coalition-driven action planning, and its examination of network structure to enhance coalition capacity. The proposed study's contribution is highly significant because the field currently lacks clear evidence of the effectiveness of a TA model applicable to the heterogeneous mix of drug prevention coalitions in operation. The research will enhance community coalition ability to bridge the research to practice gap in drug prevention programming. Results are expected to have a positive impact on the field by establishing the evidence-base for a low-cost, data-driven, manualized TA model that identifies how to intervene with community coalitions to support sustained implementation of evidence-based drug prevention programs and policies known to promote community health.

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.
68

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
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Prevention Research Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be eligible coalitions must be fully operational, thus: 1) have been in existence for at least one year; 2) have a designated coordinator; 3) have at least quarterly meetings in which multiple sectors of the community attend; 4) currently support implementation of drug prevention activities or secured funding to do so; 5) be willing to complete coalition capacity and EBP implementation assessments annually; 7) be willing to participate in four in-person meetings annually with the CCU TA provider.

Exclusion Criteria:

  • Exist outside of Pennsylvania or Missouri

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: Single

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.
Experimental: Coalition Check-Up
The 4-step Coalition Check-Up technical assistance process provides proactive data-driven continuous quality improvement cycles. Step 1 assesses critical dimensions of the coalition's capacity and program implementation. A coalition profile based on assessment data is reviewed in step 2. Here the technical assistance provider works with the coalition to consider several dimensions of coalition capacity and program implementation, celebrating strengths and prioritizing weaknesses. Once priorities are set, the technical assistance provider uses structured action planning in step 3 to help coalition members establish consensus on how to improve prioritized weaknesses. In step 4, technical assistance providers review and support progress on action plan implementation with the coalition. Efforts are evaluated a year after the initial assessment in a continuous quality improvement cycle.
Behavioral: Coalition Check-Up
The Coalition Check-Up identifies and addresses coalition and implementation capacity deficiencies that frequently lead to failure, following recommendations from the audit and feedback literature.
No Intervention: Technical assistance as usual
Coalitions in the comparison condition will receive a feedback report but no additional support from technical assistance providers beyond what is already available to them.

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
Cohesion
Time Frame: 3 years
the extent to which coalition members perceived feelings of unity, group spirit, trust, and belonging within their coalition. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
3 years
Efficiency
Time Frame: 3 years
the work ethic, efficiency, and task focus of the coalition members. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
3 years
Decentralization
Time Frame: 3 years
a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization).
3 years
Multiplexity
Time Frame: 3 years
the number of unique types of cooperation or interaction each partner reported for a relationship with another partner (e.g., sharing information, personnel, monetary resources, or other cooperation). Ranges from 0 (no multiplexity) to 4 (high multiplexity).
3 years
Intersectoral communication
Time Frame: 3 years
respondents name individuals in the coalition to whom they went to for advice about coalition matters. When an individual cited a person from a different sector as someone to whom they went for advice, that dyad is counted as an intersectoral tie. The level of intersectoral communication for each coalition is measured as the coalition's mean number of intersectoral ties per respondent, which ranges from 0 (no intersectoral ties) to 5 (all intersectoral ties).
3 years
Evidenced-based program quantity
Time Frame: 3 years
computed as the number of youth reached annually by all coalition-supported evidence-based programs
3 years
Evidence-based program implementation quality
Time Frame: 3 years
a composite of 7 scales: a) Staff training (6 items); b) Staff motivation and competence (5 items); c) Fidelity monitoring (11 items); d) Evaluation (13 items); e) Dosage (2 items); f) Adherence (7 items); and g) Implementation barriers (11 items). Scores range from 0 (low implementation quality) to 6 (high implementation quality).
3 years
Overall Evidence-based program sustainability
Time Frame: 3 years
the sum number of years all EBPs are in operation during years 2-4 of the project, including both existing and new EBPs. An EBP will be designated as non-operational when: a) it has no reach; or b) an absence of ongoing training or TA in the past 12 months and no funding available to support the program
3 years
Sustainability planning
Time Frame: 3 years
the mean of 12 items about the completion of sustainability planning activities. Ranges from 0 = no sustainability planning to 4 = extensive sustainability planning.
3 years
Dichotomized lifetime alcohol use
Time Frame: 3 years
Past use of alcohol ever (yes = 1 / no = 0)
3 years
Dichotomized lifetime tobacco use
Time Frame: 3 years
Past use of tobacco ever (yes = 1 / no = 0)
3 years
Dichotomized lifetime marijuana use
Time Frame: 3 years
Past use of marijuana ever (yes = 1 / no = 0)
3 years
Dichotomized lifetime opioid use
Time Frame: 3 years
Past use of prescription pain relievers without a doctor's orders or heroin ever (yes = 1 / no = 0)
3 years
Past 30-day alcohol use
Time Frame: 3 years
Past 30-day use of alcohol (yes = 1 / no = 0)
3 years
Past 30-day tobacco use
Time Frame: 3 years
Past 30-day use of tobacco (yes = 1 / no = 0)
3 years
Past 30-day marijuana use
Time Frame: 3 years
Past 30-day use of marijuana (yes = 1 / no = 0)
3 years
Past 30-day opioid use
Time Frame: 3 years
Past 30-day use of prescription pain relievers without a doctor's orders or heroin (yes = 1 / no = 0)
3 years

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.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah M Chilenski, PhD, Penn State University
  • Principal Investigator: Louis D Brown, PhD, The University of Texas Health Science Center, Houston

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

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.
October 20, 2020

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.
May 15, 2024

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.
May 15, 2024

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).
October 12, 2020

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.
October 12, 2020

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.
October 19, 2020

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.
December 11, 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.
December 5, 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.
December 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.
  • HSC-SPH-19-0033
  • R01DA045815 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request, we will share de-identified data from published studies with interested investigators once they have obtained IRB approval. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of communities and schools with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any participants; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.

IPD Sharing Time Frame

Data will be available after publication

IPD Sharing Access Criteria

We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any participants; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings