Feasibility of the 5-Step Method in the U.S.

Villanova University

Status: Enrolling

Conditions: Family Members; Coping Skills; Substance-Related Disorders; Relatives; Stress Physiology; Stress, Psychological; Alcohol-Related Disorders

Treatments: Behavioral: 5-Step Method Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06565429

IRB-FY2024-145

Details and patient eligibility

About

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.

Full description

The study will be implemented in the Northern Shenandoah Valley area. 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. Recruitment for the study will include advertisements via social media, local 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 36 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• at least 18 years old
• able to read, write, speak, and understand English
• live in approximately 100-mile radius of Winchester, VA/ in the Northern Shenandoah Valley
• 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 is physically violent towards others

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

5-Step Method Intervention Group

Experimental group

Description:

Receives the 5-Step Method intervention self-help handbook and emails every two weeks to encourage continued use

Treatment:

Behavioral: 5-Step Method Intervention

Control Group

No Intervention group

Description:

Standard of care.