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

NCT06565429 | Recruiting

• 1 other identifier: IRB-FY2024-145
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Social Support

Outcome Measures

Primary Outcomes (7)

• Acceptability

  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.

  One year post completing the intervention

• Study process rates

  Study process rates will be assessed by quantitatively tracking the recruitment rate, retention rate, refusal rate, eligibility rate, and study completion rate.

  One year post completing the intervention. Rates will be tallied at the end of the study

• Likelihood of adverse events

  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

  One year post completing the intervention

• Resources

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

  One year post completing the intervention

• Adherence to treatment protocol

  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.

  12 weeks after starting study, if placed in the intervention group

• Marketing

  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.

  One year post completing the intervention. Will review responses and tally results

• Ease of use

  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.

  One year post completing the intervention

Secondary Outcomes (4)

• Stress

  Baseline and change over 12 week period

• Coping

  Baseline and change over 12 week period

• Strain

  Baseline and change over 12 week period

• Social Support

  Baseline and change over 12 week period

Study Arms (2)

5-Step Method Intervention Group

EXPERIMENTAL

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

Behavioral: 5-Step Method Intervention

Control Group

NO INTERVENTION

Standard of care.

Interventions

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.

5-Step Method Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Villanova University: lead

Study Sites (1)

Online Study

Winchester, Virginia, 22601, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 19133888 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• 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

  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

  BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol-Related Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Therese M Collins, MS, RN

  Villanova University

  PRINCIPAL INVESTIGATOR

• Helene Moriarty, PhD, RN, FAAN

  Villanova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Therese M Collins, MS, RN

CONTACT

540-692-9103; tcolli13@villanova.edu

Helene Moriarty, PhD, RN, FAAN

CONTACT

610-519-5735; helene.moriarty@villanova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 22, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)