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

Primary Purpose

Substance Use, Adolescent Problem Behavior

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coalition Check-Up
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coalition Check-Up

Technical assistance as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cohesion
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
Efficiency
the work ethic, efficiency, and task focus of the coalition members. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
Decentralization
a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization).
Multiplexity
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).
Intersectoral communication
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).
Evidenced-based program quantity
computed as the number of youth reached annually by all coalition-supported evidence-based programs
Evidence-based program implementation quality
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).
Overall Evidence-based program sustainability
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
Sustainability planning
the mean of 12 items about the completion of sustainability planning activities. Ranges from 0 = no sustainability planning to 4 = extensive sustainability planning.
Dichotomized lifetime alcohol use
Past use of alcohol ever (yes = 1 / no = 0)
Dichotomized lifetime tobacco use
Past use of tobacco ever (yes = 1 / no = 0)
Dichotomized lifetime marijuana use
Past use of marijuana ever (yes = 1 / no = 0)
Dichotomized lifetime opioid use
Past use of prescription pain relievers without a doctor's orders or heroin ever (yes = 1 / no = 0)
Past 30-day alcohol use
Past 30-day use of alcohol (yes = 1 / no = 0)
Past 30-day tobacco use
Past 30-day use of tobacco (yes = 1 / no = 0)
Past 30-day marijuana use
Past 30-day use of marijuana (yes = 1 / no = 0)
Past 30-day opioid use
Past 30-day use of prescription pain relievers without a doctor's orders or heroin (yes = 1 / no = 0)

Secondary Outcome Measures

Full Information

First Posted
October 12, 2020
Last Updated
November 1, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA), Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT04592120
Brief Title
Randomized Trial of a Data-driven Technical Assistance System for Drug Prevention Coalitions
Official Title
Randomized Trial of a Data-driven Technical Assistance System for Drug Prevention Coalitions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA), Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Adolescent Problem Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At baseline, community coalitions will be randomly assigned to either the Coalition Check-Up experimental condition or the technical assistance as usual comparison condition.
Masking
Outcomes Assessor
Masking Description
Data collectors and data analysts will be blind to study condition
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coalition Check-Up
Arm Type
Experimental
Arm Description
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.
Arm Title
Technical assistance as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coalition Check-Up
Intervention Description
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 Outcome Measure Information:
Title
Cohesion
Description
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
Time Frame
3 years
Title
Efficiency
Description
the work ethic, efficiency, and task focus of the coalition members. 3 likert scale items range from 1 = strongly disagree to 5 = strongly agree
Time Frame
3 years
Title
Decentralization
Description
a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization).
Time Frame
3 years
Title
Multiplexity
Description
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).
Time Frame
3 years
Title
Intersectoral communication
Description
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).
Time Frame
3 years
Title
Evidenced-based program quantity
Description
computed as the number of youth reached annually by all coalition-supported evidence-based programs
Time Frame
3 years
Title
Evidence-based program implementation quality
Description
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).
Time Frame
3 years
Title
Overall Evidence-based program sustainability
Description
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
Time Frame
3 years
Title
Sustainability planning
Description
the mean of 12 items about the completion of sustainability planning activities. Ranges from 0 = no sustainability planning to 4 = extensive sustainability planning.
Time Frame
3 years
Title
Dichotomized lifetime alcohol use
Description
Past use of alcohol ever (yes = 1 / no = 0)
Time Frame
3 years
Title
Dichotomized lifetime tobacco use
Description
Past use of tobacco ever (yes = 1 / no = 0)
Time Frame
3 years
Title
Dichotomized lifetime marijuana use
Description
Past use of marijuana ever (yes = 1 / no = 0)
Time Frame
3 years
Title
Dichotomized lifetime opioid use
Description
Past use of prescription pain relievers without a doctor's orders or heroin ever (yes = 1 / no = 0)
Time Frame
3 years
Title
Past 30-day alcohol use
Description
Past 30-day use of alcohol (yes = 1 / no = 0)
Time Frame
3 years
Title
Past 30-day tobacco use
Description
Past 30-day use of tobacco (yes = 1 / no = 0)
Time Frame
3 years
Title
Past 30-day marijuana use
Description
Past 30-day use of marijuana (yes = 1 / no = 0)
Time Frame
3 years
Title
Past 30-day opioid use
Description
Past 30-day use of prescription pain relievers without a doctor's orders or heroin (yes = 1 / no = 0)
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis D Brown, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah M Chilenski, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention Research Center
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34172065
Citation
Brown LD, Chilenski SM, Wells R, Jones EC, Welsh JA, Gayles JG, Fernandez ME, Jones DE, Mallett KA, Feinberg ME. Protocol for a hybrid type 3 cluster randomized trial of a technical assistance system supporting coalitions and evidence-based drug prevention programs. Implement Sci. 2021 Jun 25;16(1):64. doi: 10.1186/s13012-021-01133-z.
Results Reference
derived

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

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