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Active, Not Recruiting

NCT Number: NCT06565429

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 of 24 participants, and 12 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Family Members Alcohol-Related Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Coping Skills Mental Disorders Relatives Stress Physiology Stress, Psychological Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online Study

Winchester, Virginia, 22601, United States

About this study

The study will be implemented in the United States using online contacts via Zoom and email. A participant in the study will be an affected family member of someone with drug and/or alcohol misuse who has been experiencing stress as a result of the substance misuse for at least the past six months. Both stress and their relative's misuse will be self-identified by the participant. A participant will reside in the United States of America. Recruitment for the study will include advertisements via social media, newspaper notices, and flyers posted at stores and healthcare sites. Once potential participants have contacted the PI and have been screened, consented, and have completed the baseline survey, they will be randomized into either the intervention group or the control group. Once randomized the participant and PI will no longer be blinded to the treatment condition. Those in the intervention group will receive the self-help handbook via the U.S. mail. The control group does not receive an intervention, but could use currently available programs if desired, although information about these programs will not be provided by the PI. All participants will receive emails at regular intervals during their 12-week study period. Because the intervention is completed at the individual level, study recruitment will occur on a rolling basis until 24 participants have been enrolled. Data regarding the feasibility of the study (recruitment, retention, refusal rates, etc.) will be collected. Baseline and follow up surveys will be compared for evidence of participant response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • at least 18 years old
  • able to read, write, speak, and understand English
  • live in the United States of America
  • be a family member who self-reports stress/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 in the study based on their understanding

Exclusion criteria

-if person states the relative with alcohol and/or drug misuse has been physically violent towards the potential participant

Treatment and study plan

5-Step Method Intervention

Behavioral

The 5-Step Method (5SM) intervention is delivered through a self-help handbook: There are writing prompts for the affected family member (AFM) in each step. The steps end with a summary, a space to reflect and a statement that the step is complete but can be reviewed as needed. The steps are: 1.Explore how the relative's drug and/or alcohol misuse is affecting the family member, causing stress and strain. 2.Determine the information the AFM needs to understand the situation using evidence-based websites in the handbook. 3.Reflect on coping styles, and which ones might be useful. 4.Determine who is a source of positive social support, and who could be one that the AFM has not used yet. 5.Review steps 1-4 and determine if the AFM is feeling less stress and strain, or if more help is needed and use websites to look for additional help. The activities should take about 1 hour per week.

Primary outcomes

  1. Acceptability

    Time frame: One 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.

  2. Study process rates

    Time frame: One 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.

  3. Likelihood of adverse events

    Time frame: One 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

  4. Resources

    Time frame: One year post completing the intervention

    How much time all individual participants spent filling out the surveys, assessed via a survey

  5. Adherence to treatment protocol

    Time frame: 12 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.

  6. Marketing

    Time frame: One 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.

  7. Ease of use

    Time frame: One 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.

Secondary outcomes

  1. Stress

    Time frame: Baseline and change over 12 week period

    Family Member Impact Questionnaire (FMI) Scores range from 0-48, with higher scores indicating higher stress.

  2. Coping

    Time frame: Baseline and change over 12 week period

    Symptom Rating Test (SRT) Scores range from 0-90. There are three subscales of coping, with higher scores on two subscales generally associated with higher scores on stress and strain. One subscale is generally associated with lower scores on stress and strain.

  3. Strain

    Time frame: Baseline and change over 12 week period

    Coping Questionnaire (CQ) Scores range from 0-60, higher scores indicating higher scores higher strain.

  4. Social Support

    Time frame: Baseline and change over 12 week period

    Alcohol, Drugs, and the Family Social Support Scale (ADF-SSS) Scores range from 0-75 for the total score. Two subscales with higher scores show improved social support, while the third subscale should have lower numbers when there is an improvement.

Sponsors and collaborators

Lead sponsor

Villanova University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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