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

Primary Purpose

Opioid-Related Disorders, Stimulant-Related Disorder, Child Neglect

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families Actively Improving Relationships (FAIR)
Standard Case Management and Referral
Sponsored by
Chestnut Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-Related Disorders focused on measuring Substance-Related Disorders, Preventive Health Services, Opioid-Related Disorders, Amphetamine-Related Disorders, Child Abuse

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Aged 16 to 30 at date of intake assessment.
  2. No misuse of opioids or use of methamphetamine more than 3 times in the last year.
  3. Parent of a child 0-18.
  4. Child in home or reunification plan in place.
  5. Lives in a participating Oregon county.
  6. Involvement or risk for involvement with self-sufficiency or child welfare systems.

Exclusion Criteria:

-

Sites / Locations

  • OSLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-FAIR

Control

Arm Description

Participants in this arm will receive the FAIR intervention.

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

Outcomes

Primary Outcome Measures

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.
Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline
Mental health symptoms as measured by the Brief Symptom Inventory (BSI). Measured at 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
Parenting behaviors as measured by the Brief Child Abuse Potential Inventory (BCAP). Measured at 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).
Costs Associated with Key Intervention Implementation Activities Over the Course of the Study
Implementation costs associated with adoption of FAIR as measured by the Cost of Implementing New Strategies (COINS).
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.
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.
Mean changes in social and health related services used as assessed by the Service Utilization Survey
Social services and health related service use as measured by the Service Utilization Survey. Measured at 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.
Mean changes in 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.
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.
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.
Program Fidelity Ratings
Fidelity ratings of FAIR program fidelity as measured through behavioral coding of FAIR supervision sessions

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2021
Last Updated
September 14, 2023
Sponsor
Chestnut Health Systems
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1. Study Identification

Unique Protocol Identification Number
NCT05380440
Brief Title
Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: FAIR
Acronym
PRE-FAIR
Official Title
Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: FAIR
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chestnut Health Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-FAIR
Arm Type
Experimental
Arm Description
Participants in this arm will receive the FAIR intervention.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive services standard case management and services .
Intervention Type
Behavioral
Intervention Name(s)
Families Actively Improving Relationships (FAIR)
Intervention Description
FAIR is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. This project will adapt the existing FAIR intervention for prevention. 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Case Management and Referral
Intervention Description
Parents will be referred for a substance abuse 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 Outcome Measure Information:
Title
Mean Changes in Drug Use Frequency and Severity from Baseline to 24-months Post-Baseline
Description
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.
Time Frame
Baseline to 24-months Post-Baseline
Title
Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline
Description
Mental health symptoms as measured by the Brief Symptom Inventory (BSI). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline to 24-months Post-Baseline
Title
Mean Changes From Baseline in Parenting Behaviors as Assessed by the BCAP at 24-months Post-Baseline
Description
Parenting behaviors as measured by the Brief Child Abuse Potential Inventory (BCAP). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline to 24-months Post-Baseline
Title
Completion of Key Intervention Implementation Activities Over the Course of the Study
Description
Measure of implementation progress as measured by the Stages of Implementation Completion (SIC).
Time Frame
Duration of the study, up to 4 years
Title
Costs Associated with Key Intervention Implementation Activities Over the Course of the Study
Description
Implementation costs associated with adoption of FAIR as measured by the Cost of Implementing New Strategies (COINS).
Time Frame
Duration of the study, up to 4 years
Title
Mean changes in parent drug cravings and stress as measured by the Parent Daily Report
Description
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.
Time Frame
Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline
Title
Mean changes in parenting stress as measured by Parenting Stress Inventory
Description
Parenting stress as measured by the Parent Stress Inventory (PSI). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Title
Mean changes in social and health related services used as assessed by the Service Utilization Survey
Description
Social services and health related service use as measured by the Service Utilization Survey. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Title
Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)
Description
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.
Time Frame
Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Title
Mean changes in drug use as measured by Urinalysis testing
Description
Urinalysis based multi-drug panel using the ICUP Drug Screening device. Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Title
Mean changes in anxiety symptoms reported as measured by the General Anxiety Disorder-7 (GAD-7)
Description
Anxiety symptoms as measured by the General Anxiety Disorder-7 (GAD-7). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Title
Mean changes in depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9)
Description
Depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9). Measured at Baseline, 4-, 8-, 12-, 18-, and 24-Months Post-Baseline.
Time Frame
Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Title
Program Fidelity Ratings
Description
Fidelity ratings of FAIR program fidelity as measured through behavioral coding of FAIR supervision sessions
Time Frame
Duration of study, up to 4 years
Secondary Outcome Measure Information:
Title
Descriptive Measures of FAIR Program Delivery
Description
Descriptives of FAIR program delivery including: fidelity, attendance, caseload size, case characteristics, and session characteristics will be collected.
Time Frame
Duration of the study, up to 4 years
Title
Mean Levels of Client Satisfaction with Services at the End of Treatment
Description
Participants' self-reported perceptions of services as measured by the Client Satisfaction with Services Questionnaire (CSQ).
Time Frame
End of treatment, average of 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Greater than 3 uses of methamphetamine of opioids in the past year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Singh, PhD
Phone
541-844-8532
Email
ryans@oslc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Robles, PhD
Phone
485-243-7939
Email
RafaelR@oslc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Saldana, PhD
Organizational Affiliation
Oregon Social Learning Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted Donahue
Phone
541-485-2711
Email
tedd@oslc.org
First Name & Middle Initial & Last Name & Degree
Lisa Saldana, PhD
Phone
541-485-6207
Email
lisas@oslc.org
First Name & Middle Initial & Last Name & Degree
Lisa Saldana, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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