NCT06565429 Feasibility of the 5-Step Method in the U.S.
| NCT ID | NCT06565429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Villanova University |
| Condition | Family Members |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-09-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 36 participants, and 18 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.
Eligibility Criteria
* at least 18 years old * able to read, write, speak, and understand English * live in approximately 100-mile radius of Winchester, VA/ in the Northern Shenandoah Valley * be a family member who self-reports stress/strain because of a relative's drug and/or alcohol misuse * have access to the Internet and a smartphone or larger device to complete study surveys * have a personal email address they do not share with others that can receive study related emails * have the ability to freely consent to participate in the study based on their understanding Exclusion Criteria: -if person states the relative with alcohol and/or drug misuse is physically violent towards others
Contact & Investigator
Therese M Collins, MS, RN
PRINCIPAL INVESTIGATOR
Villanova University
Frequently Asked Questions
Who can join the NCT06565429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Family Members. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565429 currently recruiting?
Yes, NCT06565429 is actively recruiting participants. Contact the research team at tcolli13@villanova.edu for enrollment information.
Where is the NCT06565429 trial being conducted?
This trial is being conducted at Winchester, United States.
Who is sponsoring the NCT06565429 clinical trial?
NCT06565429 is sponsored by Villanova University. The principal investigator is Therese M Collins, MS, RN at Villanova University. The trial plans to enroll 36 participants.