FAIR Program for Substance Use Disorders

(PRE-FAIR Trial)

Not currently recruiting at 1 trial location

Overseen By Rafael Robles, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Chestnut Health Systems

Disqualifiers: Frequent methamphetamine or opioid use

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Families Actively Improving Relationships (FAIR) to assist young parents at risk of misusing opioids or methamphetamines. It targets parents aged 16 to 30 involved with child welfare or self-sufficiency systems and enrolled in the Oregon Health Plan. The trial aims to determine if FAIR can prevent substance use issues and enhance mental health and parenting skills compared to regular case management services. Participants will be randomly assigned to either the FAIR program or standard services to compare outcomes. The trial specifically seeks parents living in certain Oregon counties who are at risk for substance misuse and have children at home or a reunification plan. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for substance misuse and family well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the FAIR program is safe for young parents?

Research shows that the Families Actively Improving Relationships (FAIR) program is safe and effective. Studies have found that parents in the FAIR program significantly reduced their use of opioids and methamphetamines. They also experienced better mental health and improved parenting skills. This suggests that participants generally handle the program well without major issues. The program aims to create safe and sober homes using proven methods. While specific side effects aren't listed, evidence supports the program's safety for participating parents. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAIR Program for Substance Use Disorders because it focuses on strengthening family relationships, which is a unique approach compared to traditional treatments that typically emphasize individual therapy or medication. Unlike standard options that primarily offer case management, the FAIR intervention actively involves family members to create a supportive environment, potentially improving long-term recovery outcomes. By addressing family dynamics, this approach could lead to more sustainable behavior changes and reduce the likelihood of relapse, offering a fresh perspective on treating substance use disorders.

What evidence suggests that this trial's treatments could be effective for substance use disorders?

Research has shown that the Families Actively Improving Relationships (FAIR) program, which participants in this trial may receive, helps reduce substance use among parents. Studies have found that it significantly lowers the use of opioids and methamphetamines, the program's main focuses. FAIR also addresses mental health and parenting issues, leading to improved family relationships and reducing the likelihood of children entering foster care. Evidence suggests that parents in the FAIR program exhibit better mental health and parenting skills compared to those receiving regular services, which is the focus of the control arm in this trial. The program aims to create safer, drug-free homes and provides comprehensive support for families at risk. ^{1 2 3 4 5}

Who Is on the Research Team?

Lisa Saldana, PhD

Principal Investigator

Chestnut Health Systems

Are You a Good Fit for This Trial?

This trial is for young parents aged 16 to 30 in Oregon who are at risk for opioid or methamphetamine addiction and have a child or a plan to reunite with their child. They must not have misused opioids or used meth more than three times last year, be involved with DHS, and live in a participating county.

Inclusion Criteria

I am between 16 and 30 years old.

Enrolled in Oregon Health Plan

Lives in a participating Oregon county

Exclusion Criteria

Greater than 3 uses of methamphetamine or opioids in the past year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FAIR intervention or standard case management services

24 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Families Actively Improving Relationships (FAIR)
• Standard Case Management and Referral

Trial Overview

The study compares the FAIR program—a community-based prevention service including mental health and parenting support—with standard case management for preventing substance misuse among high-risk parents. It will involve 240 participants randomized into two groups across two counties.

How Is the Trial Designed?

Group I: Pre-FAIR Experimental Treatment 1 Intervention

Participants in this arm will receive the FAIR intervention.

Group II: Control Active Control 1 Intervention

Participants in this arm will receive services standard case management and services .

Who Is Running the Clinical Trial?

Chestnut Health Systems

Lead Sponsor

Trials

27

Recruited

24,500+

Oregon Social Learning Center

Lead Sponsor

Trials

36

Recruited

8,900+

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]

Citations

1.

cebc4cw.org

cebc4cw.org/program/families-actively-improving-relationships/

CEBC » Program › Families Actively Improving Relationships

FAIR targets parents at risk of child welfare referral, using individualized treatment for substance abuse, mental health, and parenting, aiming to reduce ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8283009/

Meeting the Needs of Families Involved in the Child ...

Outcomes show statistically and clinically significant reductions in parental opioid and methamphetamine use, mental health symptoms, and parenting risk.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5415408/

An Integrated Intervention to Address the Comorbid Needs ...

This paper describes the initial testing of an intervention developed to meet the complex needs of such families. The Families Actively Improving Relationships ...

4.

oslc.org

oslc.org/wp-content/uploads/2016/04/FAIRFinalReport.pdf

FAIR PROGRAM

FAIR was designed to provide evidence-based treatment approaches shown to achieve positive proximal outcomes (improved parenting, sobriety, mental health.

5.

cebc4cw.org

cebc4cw.org/program/families-actively-improving-relationships/detailed

Families Actively Improving Relationships › Program ...

With the overall goal of creating safe and sober households, treatment includes a focus on addressing progress in the following areas: Substance abuse; Mental ...