Substance Use Clinical Trial
Official title:
Randomized Trial of a Data-driven Technical Assistance System for Drug Prevention Coalitions
Verified date | December 2023 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 68 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Prevention Research Center | University Park | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | National Institute on Drug Abuse (NIDA), Penn State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Decentralization | a combination of hierarchy, connectedness, average path length and clustering. Ranges from 0 (complete centralization) to 1 (complete decentralization). | 3 years | |
Primary | 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 | |
Primary | 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 | |
Primary | Evidenced-based program quantity | computed as the number of youth reached annually by all coalition-supported evidence-based programs | 3 years | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Dichotomized lifetime alcohol use | Past use of alcohol ever (yes = 1 / no = 0) | 3 years | |
Primary | Dichotomized lifetime tobacco use | Past use of tobacco ever (yes = 1 / no = 0) | 3 years | |
Primary | Dichotomized lifetime marijuana use | Past use of marijuana ever (yes = 1 / no = 0) | 3 years | |
Primary | Dichotomized lifetime opioid use | Past use of prescription pain relievers without a doctor's orders or heroin ever (yes = 1 / no = 0) | 3 years | |
Primary | Past 30-day alcohol use | Past 30-day use of alcohol (yes = 1 / no = 0) | 3 years | |
Primary | Past 30-day tobacco use | Past 30-day use of tobacco (yes = 1 / no = 0) | 3 years | |
Primary | Past 30-day marijuana use | Past 30-day use of marijuana (yes = 1 / no = 0) | 3 years | |
Primary | 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 |
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