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Youth Engagement Strategy for Opioid Use Disorder
N/A
Recruiting
Led By Parissa J Ballard, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
Study Summary
This trial will test the feasibility, acceptability, and effectiveness of a Youth Engagement strategy to help prevent opioid misuse in a small pilot RCT. Up to 60 people will be recruited to compare effects on organization and individual-level outcomes.
Who is the study for?
This trial is for leaders or staff of North Carolina-based community organizations focused on opioid misuse prevention. These organizations should be ready and interested in incorporating Youth Engagement (YE) strategies, with the necessary resources to do so. Participants must speak English fluently. It also includes volunteers aged 16-29 engaged in these efforts. Organizations already highly involved in YE are excluded.Check my eligibility
What is being tested?
The study tests a new strategy that involves youth more deeply in substance misuse prevention programs within community organizations. Phase 1 develops and tests this approach's feasibility; Phase 2 uses a small-scale randomized controlled trial to compare outcomes between groups using the YE strategy and those not using it.See study design
What are the potential side effects?
Since this is an organizational-level intervention rather than a medical treatment, traditional side effects are not applicable. However, potential negative impacts could include increased workload for staff or possible resistance from individuals less receptive to changes in program structure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perceived Usefulness of YE prevention
Perceived effectiveness, quality, reach, and usefulness of general prevention approaches
Retention Percentage of Youth/Young Adults in YE Prevention Programming
+1 moreSecondary outcome measures
Youth/young adults: beliefs and intentions related to substance use
Youth/young adults: leadership and communication skills
Youth/young adults: meaningful social role
+3 moreOther outcome measures
Exploratory--Perceived Usefulness of YE prevention, Qualitative
Exploratory--Perceived effectiveness, quality, reach, and usefulness of general prevention approaches, Qualitative
Exploratory--Reach of YE Prevention Efforts in the Community, Qualitative
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 interventionExperimental Treatment1 Intervention
In this arm the study will implement an organization-level Youth Engagement prevention strategy by systematically incorporating Youth Engagement into prevention efforts in a community setting.
Group II: Phase 2 controlActive Control1 Intervention
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,666 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,671 Total Patients Enrolled
67 Trials studying Substance Use
37,866 Patients Enrolled for Substance Use
Parissa J Ballard, PhDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
1,500 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organization highly involves youth in its prevention efforts.I am between 16 and 29 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 control
- Group 2: Phase 2 intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants still being admitted to this experiment?
"As listed on clinicaltrials.gov, this medical trial is not accepting participants at the moment; it initially posted on July 1st 2023 and saw its last update on February 9th 2023. Nevertheless, there are currently 487 other studies recruiting patients right now."
Answered by AI
What is the objective of this experimental research?
"This medical trial has been scheduled to last for 6 months, with the primary outcome being the retention percentage of youth and young adults in YE prevention programming. Secondary outcomes include self-efficacy, self esteem, and social connectedness which will be measured through surveys administered at baseline (pre-YE) and post intervention using a 1-5 scale where higher scores represent greater levels of each indicator; results will then be reported as changes from pre to post intervention."
Answered by AI
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