Clinical trial NCT05380440: Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: FAIR
Official title: Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: FAIR
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Stimulant-Related Disorder
Child Neglect
Mental Health Impairment
Keywords: Substance-Related Disorders
Preventive Health Services
Opioid-Related Disorders
Amphetamine-Related Disorders
Child Abuse
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Changes in Drug Use Frequency and Severity from Baseline to 24-months Post-Baseline
timeFrame: Baseline to 24-months Post-Baseline
measure: Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline
timeFrame: Baseline to 24-months Post-Baseline
measure: Mean Changes From Baseline in Parenting Behaviors as Assessed by the BCAP at 24-months Post-Baseline
timeFrame: Baseline to 24-months Post-Baseline
measure: Completion of Key Intervention Implementation Activities Over the Course of the Study
timeFrame: Duration of the study, up to 4 years
measure: Costs Associated with Key Intervention Implementation Activities Over the Course of the Study
timeFrame: Duration of the study, up to 4 years
measure: Mean changes in parent drug cravings and stress as measured by the Parent Daily Report
timeFrame: Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline
measure: Mean changes in parenting stress as measured by Parenting Stress Inventory
timeFrame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
measure: Mean changes in social and health related services used as assessed by the Service Utilization Survey
timeFrame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
measure: Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)
timeFrame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
measure: Mean changes in drug use as measured by Urinalysis testing
timeFrame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
measure: Mean changes in anxiety symptoms reported as measured by the General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
measure: Mean changes in depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
measure: Program Fidelity Ratings
timeFrame: Duration of study, up to 4 years
Secondary outcomes:
measure: Descriptive Measures of FAIR Program Delivery
timeFrame: Duration of the study, up to 4 years
measure: Mean Levels of Client Satisfaction with Services at the End of Treatment
timeFrame: End of treatment, average of 9 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Chestnut Health Systems
state: Oregon
Study officials:
affiliation: Chestnut Health Systems
name: Lisa Saldana, PhD
role: PRINCIPAL_INVESTIGATOR
References: