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

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 24 participants, and 12 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.

NCT Number	NCT06565429
Lead Sponsor	Villanova University
Conditions	Family Members, Relatives, Substance-Related Disorders, Alcohol-Related Disorders, Coping Skills, Stress, Psychological, Stress Physiology
Enrollment	24 participants
Start Date	2024-09-01
Primary Completion	2026-08-06 (estimated)
Study Completion	2026-08-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-12