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

NCT ID: NCT06565429

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-01

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

5-Step Method Intervention Group

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

Group Type: EXPERIMENTAL

5-Step Method Intervention

Intervention Type: 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.

Control Group

Standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

5-Step Method Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

-if person states the relative with alcohol and/or drug misuse is physically violent towards others

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Villanova University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Therese M Collins, MS, RN

Role: PRINCIPAL_INVESTIGATOR

Villanova University

Helene Moriarty, PhD, RN, FAAN

Role: PRINCIPAL_INVESTIGATOR

Villanova University

Locations

Online Study

Winchester, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Therese M Collins, MS, RN

Role: CONTACT

tcolli13@villanova.edu

540-692-9103

Helene Moriarty, PhD, RN, FAAN

Role: CONTACT

helene.moriarty@villanova.edu

610-519-5735

Facility Contacts

Therese Collins

Role: primary

References

Copello A, Templeton L, Orford J, Velleman R, Patel A, Moore L, MacLeod J, Godfrey C. The relative efficacy of two levels of a primary care intervention for family members affected by the addiction problem of a close relative: a randomized trial. Addiction. 2009 Jan;104(1):49-58. doi: 10.1111/j.1360-0443.2008.02417.x.

Reference Type: BACKGROUND

PMID: 19133888 (View on PubMed)

Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

Reference Type: BACKGROUND

PMID: 28851459 (View on PubMed)

Velleman, R., Orford, J., Templeton, L., Copello, A., Patel, A., Moore, L., Macleod, J., & Godfrey, C. (2011). 12-month follow-up after brief interventions in primary care for family members affected by the substance misuse problem of a close relative. Addiction Research & Theory, 19(4), 362-374. https://doi.org/10.3109/16066359.2011.564691

Reference Type: BACKGROUND

Orford, J., Templeton, L., Patel, A., Copello, A., & Velleman, R. (2007a). The 5-step family intervention in primary care: I. strengths and limitations according to family members. Drugs: Education, Prevention and Policy, 14(1), 29-47. https://doi.org/10.1080/09687630600997451

Reference Type: BACKGROUND

Other Identifiers

IRB-FY2024-145

Identifier Type: -

Identifier Source: org_study_id