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

Part of paid clinical trials in Winchester, Virginia.

Sponsor
Villanova University
Study ID
NCT06565429
Status
Recruiting
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Conditions

  • Alcohol-Related Disorders
  • Coping Skills
  • Family Members
  • Relatives
  • Stress Physiology
  • Stress, Psychological
  • Substance-Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-Step Method Intervention — BEHAVIORAL
    The 5-Step Method (5SM) intervention is delivered through a self-help handbook: There are writing prompts for the affected family member (AFM) in each step. The steps end with a summary, a space to reflect and a statement that the step is complete but can be reviewed as needed. The steps are: 1.Explore how the relative's drug and/or alcohol misuse is affecting the family member, causing stress and strain. 2.Determine the information the AFM needs to understand the situation using evidence-based websites in the handbook. 3.Reflect on coping styles, and which ones might be useful. 4.Determine who is a source of positive social support, and who could be one that the AFM has not used yet. 5.Review steps 1-4 and determine if the AFM is feeling less stress and strain, or if more help is needed and use websites to look for additional help. The activities should take about 1 hour per week.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Sep 2025
Primary completion
Aug 6, 2026
Completion
Aug 6, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 5-Step Method Intervention Group
    Receives the 5-Step Method intervention self-help handbook and emails every two weeks to encourage continued use
  • No Intervention: Control Group
    Standard of care.

Primary Outcome Measure

Acceptability [ Time Frame: One year post completing the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Online StudyWinchesterVirginia22601
Therese Collins

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