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NCT06565429
Feasibility of the 5-Step Method in the U.S.
NA trial testing 5-Step Method Intervention in Family Members in 36 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | Villanova University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 1 September 2024 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 5-Step Method Intervention
Conditions studied
- Family Members — all drugs for Family Members →
- Relatives — all drugs for Relatives →
- Substance-Related Disorders — all drugs for Substance-Related Disorders →
- Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →
Sponsor
Villanova University
Who can join
18 and older, any sex, with Family Members or Relatives. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06565429
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Villanova University trials
Trials by the same sponsor.
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- NCT05674110 — Screening and Nutrition for Patients With Diabetes: A Pilot Study · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06565429 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Villanova University
- Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06565429.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing