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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called the 5-Step Method to support family members affected by a relative's drug or alcohol misuse. The researchers aim to determine if this method can be successfully introduced in the U.S. and to monitor any changes in participants' stress levels. Participants will either receive a self-help handbook with guidance on the 5-Step Method or have the option to use existing support programs like Al-Anon. Ideal participants are family members living near Winchester, VA, who feel stressed due to a loved one's substance use and have internet access.

As an unphased trial, this study offers a unique opportunity to contribute to innovative support methods for families.

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 prior data suggests that the 5-Step Method is safe for families affected by substance use?

Research has shown that the 5-Step Method is safe for use. This method, tested in various locations, assists families dealing with a loved one's substance use. Participants often feel less stressed about their family member’s issues after completing the program.

The method helps family members understand and cope with the effects of a relative's drug or alcohol problems. It includes listening, providing information, and offering support. No harmful side effects have been reported from using this method.

Overall, the 5-Step Method is easy to handle and has proven effective in helping families manage stress related to a loved one's substance use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 5-Step Method for families affected by substance use because it offers a fresh, proactive approach. Unlike traditional treatments that often focus solely on the individual with substance use issues, this method empowers family members with a self-help handbook and regular email support to encourage ongoing engagement. This is unique because it not only helps families better understand and cope with their situation but also actively involves them in the recovery process, potentially leading to more comprehensive and sustainable outcomes.

What evidence suggests that the 5-Step Method is effective for families affected by substance use?

Research shows that the 5-Step Method, which participants in this trial may receive, can assist family members with a relative struggling with substance use. Studies have found that this method supports by listening, providing specific information, and teaching coping strategies. Research in other countries, such as the Netherlands, has demonstrated improvements in family members' mental health and quality of life. These early findings suggest that the 5-Step Method can be a valuable support for families facing substance use issues. ^{2 4 5 6 7}

Who Is on the Research Team?

Therese M Collins, MS, RN

Principal Investigator

Villanova University

Helene Moriarty, PhD, RN, FAAN

Principal Investigator

Villanova University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. tandfonline.com tandfonline.com/doi/abs/10.3109/09687637.2010.514234

The 5-Step Method: Evidence of gains for affected family ... The evaluation studies conducted to date provide a strong platform from which to roll-out the 5-Step Method in routine practice.

2. researchgate.net researchgate.net/publication/232057999_The_5-Step_Method_Evidence_of_gains_for_affected_family_members

The 5-Step Method: Evidence of gains for affected family ... The five-step methods include listening, reassuring and exploring concerns; providing targeted information; exploring coping strategies; discussing social ...

3. link.springer.com link.springer.com/chapter/10.1007/978-3-031-82583-5_18

The 5-Step Method: Evidence and Implementation The 5-Step Method is a psychosocial intervention that aims to support those affected by another's alcohol, other drug or gambling behaviour in their own right.

4. tandfonline.com tandfonline.com/doi/full/10.1080/09687637.2023.2165040

Helping family members affected by a relative's substance ... The goal of this study is to evaluate the routinely delivered 5-Step Method in the Netherlands using measures at baseline (N = 145), and end-of-treatment (N = ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dar.13607

The effectiveness of psychosocial interventions for family ... Outcomes included psychological functioning, quality of life, physical health and substance use, family functioning and coping. Outcomes were ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06565429

NCT06565429 | Feasibility of the 5-Step Method in the U.S. 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 ...

7. iahip.org iahip.org/page-1075642

The 5-Step Method of Helping Family Members Affected by ... A treatment package to improve primary care services for relatives of people with alcohol and drug problems.