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Behavioural Intervention

5-Step Method for Families Affected by Substance Use

N/A
Recruiting
Led By Helene Moriarty, PhD, RN, FAAN
Research Sponsored by Villanova University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* at least 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post completing the intervention
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test a new intervention called the 5-Step Method for family members affected by a relative's drug or alcohol misuse in the United States. The study will have 36 participants divided

Who is the study for?
This trial is for family members over 18 in the Winchester, VA area who are stressed due to a relative's drug or alcohol misuse. Participants must speak English, have private email access, and internet with a smartphone or similar device. They should live with the relative or have contact at least three times weekly.
What is being tested?
The study tests the feasibility of the '5-Step Method,' a behavioral intervention for those affected by relatives' substance abuse in the U.S. It involves 36 participants split into two groups: one using a self-help handbook and another free to use existing support programs.
What are the potential side effects?
Since this is a behavioral intervention focusing on coping skills rather than medication, traditional physical side effects are not expected; however, emotional distress while dealing with sensitive issues may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post completing the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post completing the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Adherence to treatment protocol
Ease of use
+4 more
Secondary study objectives
Coping
Social Support
Strain
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 5-Step Method Intervention GroupExperimental Treatment1 Intervention
Receives the 5-Step Method intervention self-help handbook and emails every two weeks to encourage continued use
Group II: Control GroupActive Control1 Intervention
Standard of care.

Find a Location

Who is running the clinical trial?

Villanova UniversityLead Sponsor
7 Previous Clinical Trials
3,185 Total Patients Enrolled
Helene Moriarty, PhD, RN, FAANPrincipal InvestigatorVillanova University
1 Previous Clinical Trials
440 Total Patients Enrolled
Therese M Collins, MS, RNPrincipal InvestigatorVillanova University
~24 spots leftby Aug 2025
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