Introducing a behavioral intervention for families affected by substance misuse
A Feasibility Study of Delivery of the 5-Step Method Intervention for Family Members of Persons With Substance Use Disorder in the United States
NA · Villanova University · NCT06565429
This study is testing a new support program for families dealing with a loved one's substance misuse to see if it helps them cope better over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Villanova University (other) |
| Locations | 1 site (Winchester, Virginia) |
| Trial ID | NCT06565429 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of implementing the 5-Step Method, a behavioral intervention designed for family members impacted by a relative's substance misuse, in the United States. It will involve a randomized control trial with 36 participants, divided into intervention and control groups. Participants in the intervention group will receive a self-help handbook, while the control group may seek other available support programs. The study will last approximately 12 weeks, during which data on recruitment, retention, and participant stress levels will be collected and analyzed.
Who should consider this trial
Good fit: Ideal candidates are family members aged 18 and older who experience stress due to a relative's drug or alcohol misuse and live within a 100-mile radius of Winchester, VA.
Not a fit: Patients whose relatives exhibit physically violent behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide valuable coping strategies and support for families dealing with substance-related disorders.
How similar studies have performed: While the 5-Step Method has not been previously evaluated in the U.S., similar behavioral interventions have shown promise in supporting families affected by substance misuse.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winchester, Virginia
- Online Study — Winchester, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Therese M Collins, MS, RN — Villanova University
- Study coordinator: Therese M Collins, MS, RN
- Email: tcolli13@villanova.edu
- Phone: 540-692-9103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Family Members, Relatives, Substance-Related Disorders, Alcohol-Related Disorders, Coping Skills, Stress, Psychological, Stress Physiology, Social Support