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

NCT04592120 | Completed DMC

• 2 other identifiers: HSC-SPH-19-0033R01DA045815
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use; Adolescent Problem Behavior

Outcome Measures

Primary Outcomes (17)

• 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

  3 years

• 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

  3 years

• Decentralization

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

  3 years

• 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).

  3 years

• 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).

  3 years

• Evidenced-based program quantity

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

  3 years

• 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).

  3 years

• 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

  3 years

• 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.

  3 years

• Dichotomized lifetime alcohol use

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

  3 years

• Dichotomized lifetime tobacco use

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

  3 years

• Dichotomized lifetime marijuana use

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

  3 years

• Dichotomized lifetime opioid use

  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

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

  3 years

• Past 30-day tobacco use

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

  3 years

• Past 30-day marijuana use

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

  3 years

• Past 30-day opioid use

  Past 30-day use of prescription pain relievers without a doctor's orders or heroin (yes = 1 / no = 0)

  3 years

Study Arms (2)

Coalition Check-Up

EXPERIMENTAL

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

Technical assistance as usual

NO INTERVENTION

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.

Interventions

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.

Coalition Check-Up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Exist outside of Pennsylvania or Missouri

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Penn State University: collaborator

Study Sites (1)

Prevention Research Center

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 34172065 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Louis D Brown, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Sarah M Chilenski, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors and data analysts will be blind to study condition
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: At baseline, community coalitions will be randomly assigned to either the Coalition Check-Up experimental condition or the technical assistance as usual comparison condition.

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication
• 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.

Locations

US (1)