Clinical trial NCT06565429: Feasibility of the 5-Step Method in the U.S.
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Members
Relatives
Substance-Related Disorders
Alcohol-Related Disorders
Coping Skills
Stress, Psychological
Stress Physiology
Keywords: Social Support
Lead sponsor: Villanova University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Acceptability
timeFrame: One year post completing the intervention
measure: Study process rates
timeFrame: One year post completing the intervention. Rates will be tallied at the end of the study
measure: Likelihood of adverse events
timeFrame: One year post completing the intervention
measure: Resources
timeFrame: One year post completing the intervention
measure: Adherence to treatment protocol
timeFrame: 12 weeks after starting study, if placed in the intervention group
measure: Marketing
timeFrame: One year post completing the intervention. Will review responses and tally results
measure: Ease of use
timeFrame: One year post completing the intervention
Secondary outcomes:
measure: Stress
timeFrame: Baseline and change over 12 week period
measure: Coping
timeFrame: Baseline and change over 12 week period
measure: Strain
timeFrame: Baseline and change over 12 week period
measure: Social Support
timeFrame: Baseline and change over 12 week period
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Online Study
state: Virginia
Study officials:
affiliation: Villanova University
name: Therese M Collins, MS, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Villanova University
name: Helene Moriarty, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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