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Completed

NCT Number: NCT04592120

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

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.

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Key information

Conditions

Substance Use Adolescent Problem Behavior Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prevention Research Center

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coalition Check-Up

Behavioral

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.

Primary outcomes

  1. 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

  2. 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. Decentralization

    Time frame: 3 years

    a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization).

  4. 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).

  5. 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).

  6. Evidenced-based program quantity

    Time frame: 3 years

    computed as the number of youth reached annually by all coalition-supported evidence-based programs

  7. 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).

  8. 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

  9. 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.

  10. Dichotomized lifetime alcohol use

    Time frame: 3 years

    Past use of alcohol ever (yes = 1 / no = 0)

  11. Dichotomized lifetime tobacco use

    Time frame: 3 years

    Past use of tobacco ever (yes = 1 / no = 0)

  12. Dichotomized lifetime marijuana use

    Time frame: 3 years

    Past use of marijuana ever (yes = 1 / no = 0)

  13. 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)

  14. Past 30-day alcohol use

    Time frame: 3 years

    Past 30-day use of alcohol (yes = 1 / no = 0)

  15. Past 30-day tobacco use

    Time frame: 3 years

    Past 30-day use of tobacco (yes = 1 / no = 0)

  16. Past 30-day marijuana use

    Time frame: 3 years

    Past 30-day use of marijuana (yes = 1 / no = 0)

  17. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Penn State University

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2020
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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