ClinicalTrials.Veeva

Menu

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

C

Chestnut Health Systems

Status

Active, not recruiting

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05380440
1174-0623

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

16 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 2 patient groups

Pre-FAIR
Experimental group
Description:
Participants in this arm will receive the FAIR intervention.
Treatment:
Behavioral: Families Actively Improving Relationships (FAIR)
Control
Active Comparator group
Description:
Participants in this arm will receive services standard case management and services .
Treatment:
Behavioral: Standard Case Management and Referral

Trial documents
1

Trial contacts and locations

1

Loading...

Central trial contact

Rafael Robles, PhD; Ryan Singh, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems