Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06565429

A Feasibility Study of Delivery of the 5-Step Method Intervention for Family Members of Persons With Substance Use Disorder in the United States

Led by Villanova University · Updated on 2025-05-23

36

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of introducing a behavioral intervention called the 5-Step Method for family members affected by a relative's misuse of drugs and/or alcohol in the United States. This randomized control trial will include 36 participants experiencing stress related to their relative's substance misuse for at least six months. The study aims to assess whether the 5-Step Method can be effectively introduced in the U.S. and to observe preliminary participant responses through baseline and follow-up surveys. Participants will be randomly assigned to either the intervention group or the control group. Those in the intervention group will receive a self-help handbook of the 5-Step Method delivered by mail, along with emails every two weeks encouraging continued use over a 12-week period. The control group will not receive the handbook from the research team but may seek out other available support programs independently. Recruitment will be ongoing until the study reaches 36 participants. During the study, participants will complete baseline and follow-up surveys to measure stress, coping, strain, and social support. Researchers will track adherence to the intervention, acceptability, ease of use, and any adverse events up to one year after completing the intervention. Data on recruitment, retention, and other process rates will also be collected. Participants need internet access and a device for completing surveys and receiving emails. Total participation lasts approximately 12 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Able to read, write, speak, and understand English
  • Live within approximately 100-mile radius of Winchester, VA, in the Northern Shenandoah Valley
  • Be a family member who self-reports stress or 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 based on their understanding
Not Eligible

You will not qualify if you...

  • If the person states the relative with alcohol and/or drug misuse is physically violent towards others

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or virtual)

Outpatient Treatment

Duration - 12 weeks

Participants in the intervention group receive a self-help handbook and emails every two weeks to guide them through the 5-Step Method intervention at home, while control group participants continue their usual care without additional intervention.

Regular email contacts every two weeks; surveys at baseline and 12 weeks

Trial Site Locations

Total: 1 location

1

Online Study

Winchester, Virginia, United States, 22601

Actively Recruiting

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Research Team

T

Therese M Collins, MS, RN

H

Helene Moriarty, PhD, RN, FAAN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

The relative efficacy of two levels of a primary care intervention for family members affected by the addiction problem of a close relative: a randomized trial.

Alex Copello, Lorna Templeton, Jim Orford...

https://pubmed.ncbi.nlm.nih.gov/19133888