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

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 research 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 Prevention Adaptation of Families Actively Improving Relationships (PRE-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 PRE-FAIR or standard case management and referral, in two counties in Oregon. Outcomes will include an evaluation of the effectiveness of PRE-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 PRE-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 PRE-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 PRE-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 PRE-FAIR; and (4) Implementation and intervention costs for PRE-FAIR will demonstrate a benefit for offering PRE-FAIR compared to standard services, particularly in rural communities where capacity influences service delivery decisions.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Mental Health Impairment; Child Neglect; Stimulant-Related Disorder
• Intervention / Treatment: Behavioral: Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR); Behavioral: Standard Case Management and Referral

Detailed Description

The Families Actively Improving Relationships (FAIR) program is a recently developed, rigorously evaluated, intensive outpatient treatment program for parents involved in the child welfare system for parental opioid and/or amphetamine type substance use disorder-methamphetamine (OUD; MUD). Outcomes from the FAIR effectiveness trial suggest the potential for FAIR to be adapted as a prevention program for parents involved with child welfare and self-sufficiency systems, and to be implemented in counties with low service availability and access. This exploratory-developmental phased project dedicates a year of activities toward collaborating with Oregon state Department of Human Services (DHS) partners and leadership to develop a plan for adaptation, recruitment, and implementation of FAIR for prevention (PRE-FAIR). The investigative team-with expertise in intervention development and clinical effectiveness trials, implementation science, decision science, health economics, and including DHS leadership-will work in collaboration with the Coordinating Center to develop strategies to identify, reach, and engage parents involved in the DHS system, aged 16 to 30, who are at-risk for escalation of misuse or development of OUD and/or MUD; and develop and adapt FAIR to prevent initiation of opioid and/or methamphetamine misuse and escalation to disorder. Following the completion of a set of concrete milestones during the first year, the project will conduct a Hybrid I randomized clinical trial, to evaluate the PRE-FAIR program and its implementation. Across two counties, parents referred by DHS for opioid or methamphetamine use or misuse with risk for escalation (n = 240), will be recruited and followed longitudinally for 24 months. Parents will be randomized to receive PRE-FAIR or standard case management and referral (STAND). Overarching goals of this study phase are to test the effectiveness of the adaptations designed in the previous phase and to build upon state collaborations-specifically, to: Evaluate the effectiveness of PRE-FAIR in preventing DHS-involved parents, aged 16 to 30, from initiating misuse or escalating opioid and/or methamphetamine use; Examine and assess the implementation of PRE-FAIR in the county-driven DHS system to inform sustainability plans; and Assess the implementation and intervention costs associated with the adoption of PRE-FAIR. Outcomes from this project will inform further refinement of protocols and the potential for broader scale-up of PRE-FAIR.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Chestnut Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

• Used methamphetamines or opioids 4 or more times in past year
• Active diagnosis of a methamphetamine or opioid use disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Participants in this arm will receive services standard case management and services .	Behavioral: Standard Case Management and Referral; Parents will be referred for a substance use 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.
Experimental: PRE-FAIR; Participants in this arm will receive the PRE-FAIR intervention.	Behavioral: Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR); FAIR is a behavioral intervention to treat parental substance use and child neglect for families involved in the child welfare system. This project will adapt the existing FAIR intervention for prevention (PRE-FAIR). 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in opioid or methamphetamine use measured from Baseline to 24 months post-baseline	Any opioid or methamphetamine use in the past 30 days measured by the Addiction Severity Index	Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Costs Associated with Key Intervention Implementation Activities Over the Course of the Study	Implementation costs associated with adoption of PRE-FAIR as measured by the Cost of Implementing New Strategies (COINS).	Duration of the study, up to 4 years
Mean changes in behavioral health services utilization	Behavioral health services utilization (mental health, substance use) including visits assessed in the Service Utilization Survey and PRE-FAIR visits assessed in the coach portal software. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	up to 24- months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Changes in probability of opioid or methamphetamine use 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
Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline	Mental health symptoms as measured by the Brief Symptom Inventory (BSI). Sum of responses to 53 Likert-type items, range 0-24. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.	Baseline to 24-months Post-Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chestnut Health Systems
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lisa Saldana, PhD, Chestnut Health Systems

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Substance-Related Disorders; Opioid-Related Disorders; Preventive Health Services; Child Abuse; Amphetamine-Related Disorders
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders; Amphetamine-Related Disorders; Professional Practice; Organization and Administration; Health Services Administration; Referral and Consultation
• Other Study ID Numbers: 1174-0623; 7UH3DA050193 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As part of the HEAL Initiative, this study will follow the data sharing protocol set up by the Collaborating Center. Plan development currently in process.
• IPD Sharing Time Frame: 2022 will be the first data upload. This will occur annually until study completion. Data will be available to the HEAL collaborative indefinitely.
• IPD Sharing Access Criteria: Must be a member of the NIDA HEAL Prevention Collaborative.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No