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NCT06565429 · ClinicalTrials.gov registry record · NA
Feasibility of the 5-Step Method in the U.S.
A NA study of Substance-Related Disorders and Stress, Psychological, sponsored by Villanova University.
- Recruiting
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06565429: Recruiting NA study of Substance-Related Disorders and Stress, Psychological, sponsored by Villanova University.
NCT06565429 is a NA study of Substance-Related Disorders and Stress, Psychological that is actively recruiting participants, run by Villanova University. The registered enrollment target is 36 participants, below the 1,521-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06565429, a NA study of Substance-Related Disorders and Stress, Psychological, is actively recruiting participants, sponsored by Villanova University.
- RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
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 36 participants, and 18 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.
Primary Outcome
Scores on Acceptability of Intervention Measure (Weiner et al., 2017), a validated and standardized instrument combined with eight other acceptability questions specific to the 5-Step Method Handbook.
Conditions Studied
Interventions
- BEHAVIORAL 5-Step Method Intervention
Study Locations (1)
Virginia
- Online Study - Winchester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What NCT06565429 shows while recruiting
NCT06565429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,521-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with Substance-Related Disorders appearing as the primary indexed condition, and to 1 intervention - of which 5-Step Method Intervention is the first listed.
NCT06565429 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06565429 about?
NCT06565429 is a clinical study titled "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 o...
What is the current status of trial NCT06565429?
This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2024-09-01. Estimated completion is 2025-12-01.
What conditions does trial NCT06565429 study?
This clinical trial studies the following conditions: Substance-Related Disorders, Stress, Psychological, Alcohol-Related Disorders, Coping Skills, Family Members.
What interventions are being tested in trial NCT06565429?
The interventions under investigation include: 5-Step Method Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06565429?
This trial is sponsored by Villanova University, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06565429 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06565429's enrollment target sits among peer trials
36 51st of 58 higher than 7 of 58 other Substance-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance-Related Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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