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Completed

NCT Number: NCT05380440

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

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Key information

Conditions

Opioid-related Disorders Amphetamine-Related Disorders Chemically-Induced Disorders Child Neglect Mental Disorders Mental Health Impairment Narcotic-Related Disorders Stimulant-Related Disorder Substance-Related Disorders

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chestnut Health Systems

Eugene, Oregon, 97401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Risk for opioid or methamphetamine misuse or escalation of use
  • Parent of a child 0-18.
  • Involvement or risk for involvement with self-sufficiency or child welfare systems.
  • Aged 16 to 30 at date of intake assessment.
  • Enrolled in Oregon Health Plan
  • Child in home or reunification plan in place.
  • 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

Treatment and study plan

Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)

Behavioral

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.

Standard Case Management and Referral

Behavioral

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.

Primary outcomes

  1. Change in opioid or methamphetamine use measured from Baseline to 24 months post-baseline

    Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline

    Any opioid or methamphetamine use in the past 30 days measured by the Addiction Severity Index

  2. Completion of Key Intervention Implementation Activities Over the Course of the Study

    Time frame: Duration of the study, up to 4 years

    Measure of implementation progress as measured by the Stages of Implementation Completion (SIC).

  3. Costs Associated with Key Intervention Implementation Activities Over the Course of the Study

    Time frame: Duration of the study, up to 4 years

    Implementation costs associated with adoption of PRE-FAIR as measured by the Cost of Implementing New Strategies (COINS).

  4. Mean changes in parent drug cravings and stress as measured by the Parent Daily Report

    Time frame: Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline

    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.

  5. Mean changes in behavioral health services utilization

    Time frame: up to 24- months

    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.

Secondary outcomes

  1. Mean Changes in Drug Use Frequency and Severity from Baseline to 24-months Post-Baseline

    Time frame: 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.

  2. Changes in probability of opioid or methamphetamine use drug use as measured by Urinalysis testing

    Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline

    Urinalysis based multi-drug panel using the ICUP Drug Screening device. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.

  3. Mean Changes From Baseline in Parenting Behaviors as Assessed by the BCAP at 24-months Post-Baseline

    Time frame: Baseline to 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.

  4. Mean changes in anxiety symptoms reported as measured by the General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline

    Anxiety symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.

  5. Mean changes in depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline

    Depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.

  6. Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)

    Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline

    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.

  7. Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline

    Time frame: 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.

  8. Mean changes in parenting stress as measured by Parenting Stress Inventory

    Time frame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline

    Parenting stress as measured by the Parent Stress Inventory (PSI). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.

  9. Descriptive Measures of FAIR Program Delivery

    Time frame: Duration of the study, up to 4 years

    Descriptives of FAIR program delivery including: fidelity, attendance, caseload size, case characteristics, and session characteristics will be collected.

  10. Mean Levels of Client Satisfaction with Services at the End of Treatment

    Time frame: End of treatment, average of 9 months

    Participants' self-reported perceptions of services as measured by the Client Satisfaction with Services Questionnaire (CSQ).

Other outcomes

  1. Program Fidelity Ratings

    Time frame: Duration of study, up to 4 years

    Fidelity ratings of FAIR program fidelity as measured through behavioral coding of FAIR supervision sessions

Sponsors and collaborators

Lead sponsor

Chestnut Health Systems

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: PRE-FAIR

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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