5-Step Method for Families Affected by Substance Use
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Villanova University
No Placebo Group
Approved in 3 jurisdictions
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.
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.
12479Do 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.
13568Eligibility 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 am at least 18 years old.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: 5-Step Method Intervention GroupExperimental Treatment1 Intervention
Receives the 5-Step Method intervention self-help handbook and emails every two weeks to encourage continued use
Group II: Control GroupActive Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Online StudyWinchester, VA
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Who is running the clinical trial?
Villanova UniversityLead Sponsor
References
Strength in numbers: the ARISE method for mobilizing family and network to engage substance abusers in treatment. A Relational Intervention Sequence for Engagement. [2019]The model described in this paper takes into consideration two key findings: (a) In a given year, the vast majority (90-95%) of active substance abusers do not enter treatment or self-help groups, and (b) substance abusers have frequent contact with their families (60-80% either live with a parent or are in daily contact). This paper presents a method for mobilizing and collaborating with families and extended the support system toward working with resistance and getting the substance abuser into treatment. Principles and techniques are provided for convening and structuring intervention network meetings toward that end. This intervention network approach can be used either alone or as part of an overall model, ARISE (A Relational Intervention Sequence for Engagement). The ARISE model addresses both clinical and programmatic issues in treatment engagement for substance abusers.
Alcohol, drugs and the family: results from a long-running research programme within the UK. [2017]This article will outline the main strands of the UK-based Alcohol, Drugs and the Family (ADF) research programme. This programme has examined the impact of substance misuse problems on children, spouses, and families, both in the UK and elsewhere, especially in urban Mexico City and in Australia amongst both urban and rural Aborigine populations. This article will outline the main theoretical perspective that we have developed from this work (the stress-strain-coping-support model). It will outline some of the key findings of this programme, and address some of the key universals that we have observed across various cultures. It will end by describing current research, including the testing of brief interventions being delivered through primary care to family members to enable them to cope better with the problems which family substance misuse causes.
Outcomes with the ARISE approach to engaging reluctant drug- and alcohol-dependent individuals in treatment. [2019]Our goal was to explore, through a Stage I NIH clinical study, the effectiveness of a manual-driven, timely response method for helping the "concerned other" get resistant substance abusers into treatment/self-help with minimum professional time/effort. A manual-driven protocol, "A Relational Sequence for Engagement (ARISE)," was applied with 110 consecutive, initial calls/contacts from concerned others; no cases excluded for research, refusal, or other reasons. The research was conducted at two upstate New York outpatient drug/alcohol clinics. Participants were concerned others who called regarding a cocaine, alcohol, or "other drug" abuser (N = 110); participating family/friends: 11 ARISE clinicians; and 110 substance abusers. ARISE is a graduated continuum starting with the least demanding option/stage, increasing effort as needed to engage substance abusers in treatment/self-help. Stage I: Coaching the concerned other to arrange a meeting of significant others, inviting the substance abuser; Stage II: 1 to 5 additional meetings (median = 2); Stage III: A modified Johnson "Intervention." Primary outcome variables were substance abuser engagement (or not) in treatment/self-help; days between first call and engagement; clinician time/effort. Predictors were concerned other, substance abuser, and clinician demographics; number of participants per case; and Collateral Addiction Severity Index. ARISE resulted in an 83% success rate (55% at Stage I). Median days to engagement was 7 (IQR = 2 to 14). Average total time (telephone, sessions) per case was 1.5 hours. Treatment/self-help chosen was 95% treatment and 5% self-help. Number of family/ friends involved correlated 0.69 with a success/efficiency index. Conclusions. A call from a family member or concerned other for help in getting a loved one into treatment is a rich opportunity for treatment professionals and agencies to engage substance abusers in treatment. These initial calls are similar to referral calls from EAPs or probation officers looking to get an individual started in treatment. ARISE provides an effective, swift, and cost-efficient option for engaging substance abusers in treatment or self-help. The more significant others involved, the greater the success of treatment engagement.
Maladaptive Coping as a Mediator of Family Stress. [2021]Family members of women substance users may be at risk for stress-related problems. Family coping responses may affect outcomes for both families and women in treatment. Eighty-two women in treatment for substance use disorders (56 with comorbid psychiatric conditions) and 82 family members were interviewed. Stressors related to women's disorders were significantly related to increased family member burden. Women's behavioral problems predicted greater family member Worry, Displeasure, and Impact. Extent of women's drug or alcohol use predicted greater family member Stigma and Impact. Family member maladaptive coping partially mediated relationships between family member stressors and family member Displeasure and Impact. Family member maladaptive coping also functioned as a moderator between the stressors and Impact.
Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse. [2021]Involving patients in treatment is becoming increasingly popular in mental health [Sales & Alves: Personalized evaluation of psychological treatments: A review of tools and research designs, submitted]. However, in substance misuse treatment settings, the patient perspective about treatment tends to be overlooked. This has been cited as a key priority by Orford et al. [Addiction, 103: 875-885, 2008] who included patient feedback about treatment as one of ten areas requiring an urgent paradigm shift in addiction research and practice.This project will apply an innovative method to involve substance misuse patients in psychological therapies, by asking them to suggest topics to evaluate their treatment. These topics suggested by patients can be written as a list of personalised items, so-called as patient-generated outcome measures (PGOM). Despite its patient-friendly features, PGOM's have never been used in this population, which is what this project aims to overcome.
Role of peer support workers in improving patient experience in Tower Hamlets Specialist Addiction Unit. [2020]The aim of the project was to improve patient experience for people in Tower Hamlets Specialist Addictions Unit in order to increase satisfaction by 25% in 12 months starting in August 2014. The team used the model for improvement as part of ELFT's quality improvement programme to support iterative cycles of testing and learning. This involved support from the Trust's quality improvement team. The theory of change was visualised through a driver diagram. A number of outcomes were measured and plotted over time - patient satisfaction, staff satisfaction, and attendance to peer support groups. The impact of changes was then observed using the plan, do, study, act (PDSA) cycles. The changes that positively influenced the outcomes were continued and ones without such impact were discontinued. The most successful intervention to improve patient satisfaction so far was the introduction of peer support facilitation for the "Breakfast club" - recovery orientated meeting of patients with less emphasis on the medical aspects of treatment. Staff satisfaction is proven to be one of the best determinants of patient experience, so this is also measured and plotted over time together with patient's satisfaction and attendance. Service user satisfaction improves attendance and outcomes in this difficult-to-engage group of patients (people with both substance misuse and mental health problems). Patient perspectives and priorities might be quite different to that of the clinical team, further supporting the importance of involving and engaging them in any quality improvement work. Involving peer support workers in improving engagement of people with substance misuse related problems appears essential.
Adaptive coping strategies of affected family members of a relative with substance misuse: A qualitative study. [2022]To explore the coping strategies used by affected family members of a relative with substance misuse.
Distilling the Core Elements of Family Therapy for Adolescent Substance Use: Conceptual and Empirical Solutions. [2020]This article describes several barriers to widespread dissemination of manualized family-based treatments for adolescent substance use (ASU). We then offer a highly promising solution for adopting and sustaining family therapy in usual care: distilling the core practice elements of empirically validated family therapy models for ASU. We present a conceptual distillation of family therapy for ASU grounded in existing observational fidelity measures for three manualized models, a process that yielded four core elements: Family Engagement, Relational Reframing, Family Behavior Change, and Family Restructuring. We then introduce an innovative empirical method for distilling core elements that can serve as a template for rigorous distillation of other treatment approaches. Finally, we discuss how core elements can enhance family therapy services within the diverse workforce of usual care for ASU.
Measuring Coping Among Family Members with Substance-Misusing Relatives: Testing Competing Factor Structures of the Coping Questionnaire (CQ) in England and Italy. [2021]Background: The Coping Questionnaire measures affected family members' responses to their relatives' substance misuse related problems. The Coping Questionnaire examines three main coping strategies: engaged, tolerant-inactive, and withdrawal coping. Objectives: The aim of the current study was to compare competing conceptual measurement models across two countries, including one-factor, three-factor, and higher order factor models. Methods: Secondary analysis of data from five previous studies was conducted. Samples of affected family members from England (N = 323) and Italy (N = 165) were aggregated into two country specific groups. Series of confirmatory factor analyses were performed to test the degree of model fit and the effects of socio-demographic variables on the coping factors. Results: A bifactor model fitted the data most closely relative to the one- and three-factor models. High rates of common variance (60-65%) were attributable to the general coping factor, while a high proportion of the variance related to the withdrawal coping subscale score was independent (66-89%) of the general coping factor. Family members' country, age, gender, the type of relationship and the main problematic substance had significant effects on the coping factors. Conclusions: A bifactor model related to coping behaviors is consistent with the theoretical assumptions of the general coping literature. The concept of a general coping factor also fits the theoretical assumptions of the stress-strain-coping-support model, with family members showing a general tendency to cope with the harmful circumstances which arise due to substance misuse.