5-Step Method for Families Affected by Substance Use

Overseen By Helene Moriarty, PhD, RN, FAAN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Villanova University

Disqualifiers: Violent relative

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the 5-Step Method treatment for families affected by substance use?

Research shows that involving family and peer support can significantly improve engagement and satisfaction in substance use treatment. The ARISE approach, which also focuses on family involvement, achieved an 83% success rate in getting substance abusers into treatment, highlighting the potential effectiveness of family-based methods like the 5-Step Method. ^{1 2 3 4 5}

How is the 5-Step Method treatment different from other treatments for families affected by substance use?

The 5-Step Method is unique because it focuses on helping family members cope with the stress and strain caused by a relative's substance use, using a model that emphasizes stress, strain, coping, and support. Unlike other treatments that may focus directly on the substance user, this method provides structured support to family members, helping them develop adaptive coping strategies and improve their well-being. ^{4 6 7 8 9}

Research Team

Helene Moriarty, PhD, RN, FAAN

Principal Investigator

Villanova University

Therese M Collins, MS, RN

Principal Investigator

Villanova University

Eligibility Criteria

This trial is for family members over 18 in the Winchester, VA area who are stressed due to a relative's drug or alcohol misuse. Participants must speak English, have private email access, and internet with a smartphone or similar device. They should live with the relative or have contact at least three times weekly.

Inclusion Criteria

I live within 50 miles of Winchester, VA.

I can read, write, speak, and understand English.

I am stressed because a family member misuses drugs or alcohol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Treatment

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

12 weeks

Regular email contact

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up surveys

1 year

Follow-up surveys

Treatment Details

Interventions

• 5-Step Method

Trial Overview The study tests the feasibility of the '5-Step Method,' a behavioral intervention for those affected by relatives' substance abuse in the U.S. It involves 36 participants split into two groups: one using a self-help handbook and another free to use existing support programs.

Participant Groups

Group I: 5-Step Method Intervention Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

Standard of care.

5-Step Method is already approved in United Kingdom for the following indications:

Approved in United Kingdom as 5-Step Method for:

• Support for family members affected by a relative's misuse of drugs and/or alcohol

Who Is Running the Clinical Trial?

Villanova University

Lead Sponsor

Trials

8

Recruited

3,200+

Findings from Research

The project aimed to increase patient satisfaction by 25% within 12 months at the Tower Hamlets Specialist Addictions Unit, using iterative testing and learning cycles to measure outcomes like patient and staff satisfaction.

The introduction of peer support facilitation for the 'Breakfast club' significantly improved patient satisfaction, highlighting the importance of engaging patients in their recovery process and the role of peer support in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of peer support workers in improving patient experience in Tower Hamlets Specialist Addiction Unit. Kulik, W., Shah, A.[2020]

This project aims to involve substance misuse patients in their treatment by using patient-generated outcome measures (PGOMs), which allow patients to suggest topics for evaluating their treatment, potentially leading to more personalized care.

The research will assess the reliability and sensitivity of PGOMs compared to standard measures, with the expectation that PGOMs will provide valuable insights into patients' personal concerns and motivations, ultimately enhancing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse. Alves, PC., Sales, CM., Ashworth, M.[2021]

The article identifies key barriers to the widespread use of family-based treatments for adolescent substance use and proposes a solution by distilling core practice elements from effective therapy models.

Four essential elements were identified for effective family therapy: Family Engagement, Relational Reframing, Family Behavior Change, and Family Restructuring, which can improve therapy services in standard care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distilling the Core Elements of Family Therapy for Adolescent Substance Use: Conceptual and Empirical Solutions. Hogue, A., Bobek, M., Dauber, S., et al.[2020]

The majority of substance abusers (90-95%) do not seek treatment on their own, highlighting the need for alternative intervention strategies that involve their families.

The ARISE model provides a structured approach to engage families in supporting substance abusers, which can enhance treatment engagement and address both clinical and programmatic challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strength in numbers: the ARISE method for mobilizing family and network to engage substance abusers in treatment. A Relational Intervention Sequence for Engagement. Landau, J., Garrett, J., Shea, RR., et al.[2019]

The ARISE protocol demonstrated an 83% success rate in engaging substance abusers into treatment or self-help, with 55% achieving this at the initial coaching stage, indicating its effectiveness in facilitating treatment access.

The average time spent by clinicians was only 1.5 hours per case, highlighting ARISE as a cost-efficient method for treatment engagement, especially as the involvement of more concerned family members significantly increased the likelihood of success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes with the ARISE approach to engaging reluctant drug- and alcohol-dependent individuals in treatment. Landau, J., Stanton, MD., Brinkman-Sull, D., et al.[2019]

Family members of women with substance use disorders experience increased stress and burden, particularly when the women have behavioral problems or comorbid psychiatric conditions, as shown in a study involving 82 women and their family members.

Maladaptive coping strategies among family members can worsen their feelings of displeasure and impact, indicating that improving coping mechanisms may help reduce the negative effects of stress related to a loved one's substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maladaptive Coping as a Mediator of Family Stress. Moore, BC., Biegel, DE., McMahon, TJ.[2021]

A study involving 31 family members of individuals with substance misuse revealed that effective coping strategies include seeking evidence-based information, enhancing personal coping methods, and accessing both informal and formal support systems.

The findings highlight the need for improved support services, especially in rural areas, to provide accessible resources and emotional support, which are crucial for family members in their caregiving roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive coping strategies of affected family members of a relative with substance misuse: A qualitative study. McCann, TV., Lubman, DI.[2022]

The study analyzed data from 488 affected family members in England and Italy, finding that a bifactor model best represents coping strategies related to substance misuse, indicating a general coping factor alongside specific withdrawal coping behaviors.

Socio-demographic factors such as country, age, gender, relationship type, and the substance involved significantly influenced how family members cope, highlighting the complexity of coping mechanisms in response to substance misuse issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Coping Among Family Members with Substance-Misusing Relatives: Testing Competing Factor Structures of the Coping Questionnaire (CQ) in England and Italy. Horváth, Z., Orford, J., Velleman, R., et al.[2021]

The UK-based Alcohol, Drugs and the Family (ADF) research programme has explored the effects of substance misuse on families, revealing significant impacts on children and spouses across different cultures, including urban Mexico City and Australian Aborigine populations.

Current research is focusing on developing brief interventions in primary care settings to help family members cope with the challenges posed by substance misuse, based on the stress-strain-coping-support model derived from the programme's findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol, drugs and the family: results from a long-running research programme within the UK. Velleman, R., Templeton, L.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Role of peer support workers in improving patient experience in Tower Hamlets Specialist Addiction Unit. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Distilling the Core Elements of Family Therapy for Adolescent Substance Use: Conceptual and Empirical Solutions. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Strength in numbers: the ARISE method for mobilizing family and network to engage substance abusers in treatment. A Relational Intervention Sequence for Engagement. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Outcomes with the ARISE approach to engaging reluctant drug- and alcohol-dependent individuals in treatment. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Maladaptive Coping as a Mediator of Family Stress. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Adaptive coping strategies of affected family members of a relative with substance misuse: A qualitative study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Measuring Coping Among Family Members with Substance-Misusing Relatives: Testing Competing Factor Structures of the Coping Questionnaire (CQ) in England and Italy. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Alcohol, drugs and the family: results from a long-running research programme within the UK. [2017]