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

NCT05380440 | Completed

• 2 other identifiers: 1174-06237UH3DA050193
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Child Neglect; Opioid-Related Disorders; Stimulant-Related Disorder; Mental Health Impairment

Keywords

Substance-Related Disorders; Preventive Health Services; Opioid-Related Disorders; Amphetamine-Related Disorders; Child Abuse

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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 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

• 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 Outcomes (10)

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

  Baseline to 24-months Post-Baseline

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

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

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

  Baseline to 24-months Post-Baseline

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

  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)

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

Other Outcomes (1)

• Program Fidelity Ratings

  Duration of study, up to 4 years

Study Arms (2)

PRE-FAIR

EXPERIMENTAL

Participants in this arm will receive the PRE-FAIR intervention.

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

Control

ACTIVE COMPARATOR

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

Behavioral: Standard Case Management and Referral

Interventions

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.

Control

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.

PRE-FAIR

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chestnut Health Systems: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Chestnut Health Systems

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Amphetamine-Related Disorders

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Lisa Saldana, PhD

  Chestnut Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: May 18, 2022
• Study Start: June 9, 2021
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Must be a member of the NIDA HEAL Prevention Collaborative.

Locations

US (1)