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Search / Trial NCT06565429

Feasibility of the 5-Step Method in the U.S.

Launched by VILLANOVA UNIVERSITY · Aug 19, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Social Support

ClinConnect Summary

This clinical trial is studying a program called the 5-Step Method to see if it can help family members who are dealing with a loved one’s misuse of drugs or alcohol. The study will involve 36 participants who will be divided into two groups: one group will receive a self-help handbook with the 5-Step Method, while the other group will not receive this specific help but can still access other support programs like Al-Anon or Nar-Anon. The trial will last about 12 weeks, and researchers want to find out if this method can be effectively introduced in the U.S. and if it shows any positive effects on participants over time.

To participate, individuals must be at least 18 years old, live near Winchester, VA, and be family members experiencing stress from a relative’s substance misuse. They should be comfortable using the internet and have their own email address for communication about the study. It’s important to note that individuals whose relatives are physically violent will not be eligible to participate. Overall, this trial aims to support families going through tough times and explore new ways to help them cope.

Gender

ALL

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

About Villanova University

Villanova University is a prominent academic institution dedicated to advancing knowledge and innovation through rigorous research and education. As a clinical trial sponsor, Villanova leverages its extensive resources and interdisciplinary expertise to facilitate groundbreaking studies that aim to improve health outcomes and enhance patient care. The university fosters a collaborative environment where faculty and students engage in meaningful research initiatives, ensuring adherence to ethical standards and regulatory compliance. By focusing on impactful clinical trials, Villanova University plays a vital role in contributing to the scientific community and addressing pressing healthcare challenges.

Locations

Winchester, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Therese M Collins, MS, RN

Principal Investigator

Villanova University

Helene Moriarty, PhD, RN, FAAN

Principal Investigator

Villanova University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported