Feasibility of the 5-Step Method for Family Members Affected by Substance Misuse
This study is testing if a behavioral intervention called the "5-Step Method" can be successfully introduced in the U.S. for family members experiencing stress due to a relative's drug or alcohol misuse. The 5-Step Method is a self-help handbook with writing prompts designed to help you cope. You might be able to join if you are at least 18, live in the U.S., can read and write English, and are experiencing stress because of a relative's substance misuse. The study aims to see how well people accept the intervention and how smoothly the study processes run. We will also track any potential side effects. This study is currently recruiting 24 participants.
- Study design
- This is an interventional study with 24 participants, divided into two groups. It is a randomized controlled trial, meaning you will be randomly assigned to either receive the 5-Step Method handbook or be in a control group.
- What's involved
- You will participate for approximately 12 weeks. If you are in the intervention group, you will receive a self-help handbook. All participants will receive emails at regular intervals and complete online surveys.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your acceptability of the intervention, study process rates, and likelihood of adverse events will be measured one year after you complete the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of the 5-Step Method in the U.S.
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Therese M Collins, MS, RN · PRINCIPAL_INVESTIGATOR · Villanova University
- Helene Moriarty, PhD, RN, FAAN · PRINCIPAL_INVESTIGATOR · Villanova University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Exclusion
What this trial measures
- AcceptabilityOne year post completing the intervention
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.
- Study process ratesOne year post completing the intervention. Rates will be tallied at the end of the study
Study process rates will be assessed by quantitatively tracking the recruitment rate, retention rate, refusal rate, eligibility rate, and study completion rate.
- Likelihood of adverse eventsOne year post completing the intervention
Safety will be assessed for all participants by quantitatively summarizing the number of adverse events that are considered to be unexpected, serious, and/or possibly or definitely related to the study
- ResourcesOne year post completing the intervention
How much time all individual participants spent filling out the surveys, assessed via a survey
- Adherence to treatment protocol12 weeks after starting study, if placed in the intervention group
The adherence to treatment protocol will be assessed by asking the intervention group questions about how they interacted with the self-help handbook to determine if they used the handbook as designed or if they used it in some other way.
- MarketingOne year post completing the intervention. Will review responses and tally results
Marketing of the study will be assessed by asking those who inquire about the study where they learned about the study to determine which locations may be better for recruitment in future studies.
- Ease of useOne year post completing the intervention
Ease of use of the study will be assessed by asking participants two questions at the end of the follow-up survey about the way the surveys were worded. The answers of these questions will be reviewed and tallied as well as qualitatively described. The surveys of the study are validated tools, and the only allowed changes to the survey questions were to change from UK English to US English on spelling alone (behaviour to behavior for example). Syntax and word choice were not allowed to be changed. It is possible that how the phrases are stated and the words used will not be as easy to read for an American as compared to someone from the UK, where the intervention was created. The two questions ask if there were any difficulties understanding the survey, and if so, did they think this may have affected how they answered any of the questions.