Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: FAIR

Opioid-Related Disorders Clinical Trial

— PRE-FAIR  

Official title:

Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: FAIR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380440
• Other study ID #: UG3DA050193
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Chestnut Health Systems
• Contact: Ryan Singh, PhD
• Phone: 541-844-8532
• Email: ryans[@]oslc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Young parents aged 16 to 30, involved in the DHS system for child welfare or self-sufficiency needs are at risk for opioid use disorder and/or methamphetamine use disorder (OUD; MUD). Those identified as engaging in opioid or methamphetamine misuse are at high risk for escalation. Children of parents with OUD and MUD are at-risk for entering into foster care. Oregon is one state particularly affected by this challenge. The proposed UG3/UH3 offers one potential solution by adapting and evaluating a recently developed treatment for parental OUD and MUD, for prevention. This study seeks to collaborate with Oregon Department of Humans Services (DHS) leadership to deliver a new outpatient prevention program to high-risk, young, parents. The Families Actively Improving Relationships (FAIR) program will include community-based mental health, parent management, and ancillary needs treatment, and ongoing monitoring and prevention services for opioid and methamphetamine use. This study will randomize 240 parents, aged 16 to 30, to receive FAIR or standard case management and referral, in two counties in Oregon. Outcomes will include an evaluation of the effectiveness of FAIR in addressing risk factors associated with substance use disorders in DHS-involved populations, OUD and MUD outcomes, and implementation outcomes including implementation process and milestones, and program delivery outcomes. Intervention and Implementation costs will be assessed, and the benefit of FAIR will be evaluated in relation to standard services, but also in relation to capacity and population needs. Study hypotheses are: (1) Parents randomized to FAIR will be less likely to escalate opioid and/or methamphetamine use, and to receive a diagnosis of OUD and/or MUD; (2) Parents randomized to FAIR will experience significant reductions in mental health, parent skills, and ancillary needs compared to those receiving standard services; (3) Counties will follow the implementation plan developed in collaboration between study team members and state leadership, and that doing so will yield successful implementation of FAIR; and (4) Implementation and intervention costs for FAIR will demonstrate a benefit for offering FAIR compared to standard services, particularly in rural communities where capacity influences service delivery decisions.

Description:

This project aims to collaborate with Oregon DHS to adapt and implement a program to prevent opioid and methamphetamine use disorders (OUD/MUD) in DHS-involved parents, age 16 to 30, at risk for escalation of use to misuse or disorder, yielding several unique innovations:

PREVENTION ACROSS TWO GENERATIONS. Although it is not feasible to evaluate long-term outcomes of participants' children, FAIR is poised to also serve as prevention for the next generation of high-risk adolescents. Indeed, a previous sample of FAIR mothers found a significant relationship between adolescent onset and severity of family drug use.19 Thus, by reducing children's risk for exposure to parental substance misuse and associated consequences, FAIR might prevent intergenerational transmission of substance use.

UNDERSTANDING PATHWAYS FROM HIGH-RISK TO OUD AND MUD. This project will leverage the investigative team's expertise in longitudinally assessing difficult-to-track samples. This study provides the opportunity to increase understanding of the services and outcomes of parents randomized to the standard control condition, as well as FAIR. This analysis will allow insight into a system's typical response for addressing identified high-risk factors for opioid and/or methamphetamine misuse and abuse, and how parent outcomes are impacted.

UNDERSTANDING SYSTEM IDENTIFICATION OF RISK FOR OUD. This study will increase the understanding of variability of risk for OUD and MUD among DHS-involved parents, along with the system's ability to detect this risk. There is the potential that, upon assessment, more parents have escalated opioid use than identified by the DHS referrers. In the recent trial, the large majority of referrals were for parental methamphetamine abuse (70%)-a high-energy and overtly symptomatic substance to use. However, upon assessment, the large majority also abused heroin or other opiates often with a more subdued presentation. This suggests under-identification by CWS caseworkers. Such knowledge might inform future points for systemic change.

ADDRESSING THE NEEDS OF RURAL COUNTIES. As a home- and community-based intervention, FAIR requires unbillable expenses such as mileage and drive time. However, in the FAIR team's current outreach to rural Lane County, 95% of the completed rural cases have reunified or maintained the children in the home due to successful parent treatment gains. This project will have the potential to examine the preventive benefit of introducing FAIR-a model that, though expensive, has shown high engagement, retention, and success rates in rural areas versus referring to the closest available traditional services.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Risk for opioid or methamphetamine misuse or escalation of use

2. Parent of a child 0-18.

3. Involvement or risk for involvement with self-sufficiency or child welfare systems.

4. Aged 16 to 30 at date of intake assessment.

5. Enrolled in Oregon Health Plan

6. Child in home or reunification plan in place.

7. Lives in a participating Oregon county.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Child Neglect
• Mental Health Impairment
• Opioid-Related Disorders

Intervention

Behavioral:
• Families Actively Improving Relationships (FAIR)
FAIR is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. This project will adapt the existing FAIR intervention for prevention. FAIR involves four major treatment components, supported by ongoing purposeful engagement : (1) Substance use treatment including contingency management and positive reinforcement, frequent urinalysis, relationship building, day planning, healthy environments and peer choices, and refusal skills; (2) Mental health treatment including cognitive behavioral therapy, developing healthy coping skills, emotion regulation skills, exposure therapy, and referral for medication management; (3) Parent management training including parenting skills, nurturing and attachment, reinforcement, emotion regulation, supervision, structure, non-harsh discipline, and nutrition; and (4) Resource building and provision of ancillary supports including assistance with housing and employment.
• Standard Case Management and Referral
Parents will be referred for a substance abuse and mental health assessment with possible resulting treatment. Child Welfare treatment plans typically include a series of recommendations, including parenting classes, securing safe housing, psychosocial treatment (e.g., domestic violence), accessing self-sufficiency services (e.g., food stamps, WIC), securing employment or education, and meeting court dates and requirements.

Locations

Country	Name	City	State
United States	OSLC	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Chestnut Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Changes in Drug Use Frequency and Severity from Baseline to 24-months Post-Baseline	Drug use frequency and severity measured through the Addiction Severity Index's (ASI) Drug Use subscale. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline to 24-months Post-Baseline
Primary	Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline	Mental health symptoms as measured by the Brief Symptom Inventory (BSI). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline to 24-months Post-Baseline
Primary	Mean Changes From Baseline in Parenting Behaviors as Assessed by the BCAP at 24-months Post-Baseline	Parenting behaviors as measured by the Brief Child Abuse Potential Inventory (BCAP). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline to 24-months Post-Baseline
Primary	Completion of Key Intervention Implementation Activities Over the Course of the Study	Measure of implementation progress as measured by the Stages of Implementation Completion (SIC).	Duration of the study, up to 4 years
Primary	Costs Associated with Key Intervention Implementation Activities Over the Course of the Study	Implementation costs associated with adoption of FAIR as measured by the Cost of Implementing New Strategies (COINS).	Duration of the study, up to 4 years
Primary	Mean changes in parent drug cravings and stress as measured by the Parent Daily Report	Parental stress and drug cravings as measured by the Parent Daily Report (PDR). Measured monthly from Baseline to 18-months post-Baseline and at 24-months post-Baseline.	Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline
Primary	Mean changes in parenting stress as measured by Parenting Stress Inventory	Parenting stress as measured by the Parent Stress Inventory (PSI). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary	Mean changes in social and health related services used as assessed by the Service Utilization Survey	Social services and health related service use as measured by the Service Utilization Survey. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary	Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)	Measure of PTSD symptoms and psychological effects of trauma as measured by the Trauma Symptoms Inventory-2 (TSI-2). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary	Mean changes in drug use as measured by Urinalysis testing	Urinalysis based multi-drug panel using the ICUP Drug Screening device. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary	Mean changes in anxiety symptoms reported as measured by the General Anxiety Disorder-7 (GAD-7)	Anxiety symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary	Mean changes in depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9)	Depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary	Program Fidelity Ratings	Fidelity ratings of FAIR program fidelity as measured through behavioral coding of FAIR supervision sessions	Duration of study, up to 4 years
Secondary	Descriptive Measures of FAIR Program Delivery	Descriptives of FAIR program delivery including: fidelity, attendance, caseload size, case characteristics, and session characteristics will be collected.	Duration of the study, up to 4 years
Secondary	Mean Levels of Client Satisfaction with Services at the End of Treatment	Participants' self-reported perceptions of services as measured by the Client Satisfaction with Services Questionnaire (CSQ).	End of treatment, average of 9 months