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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05380440
Other study ID # UG3DA050193
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 9, 2021
Est. completion date August 31, 2025

Study information

Verified date September 2023
Source Chestnut Health Systems
Contact Ryan Singh, PhD
Phone 541-844-8532
Email ryans@oslc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
United States OSLC Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
Chestnut Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to 24-months Post-Baseline
Primary 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. Baseline to 24-months Post-Baseline
Primary 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. Baseline to 24-months Post-Baseline
Primary 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
Primary 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). Duration of the study, up to 4 years
Primary 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
Primary 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. Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary 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. Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary 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. Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary 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. Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary 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. Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary 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. Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Primary Program Fidelity Ratings Fidelity ratings of FAIR program fidelity as measured through behavioral coding of FAIR supervision sessions Duration of study, up to 4 years
Secondary Descriptive Measures of FAIR Program Delivery Descriptives of FAIR program delivery including: fidelity, attendance, caseload size, case characteristics, and session characteristics will be collected. Duration of the study, up to 4 years
Secondary 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). End of treatment, average of 9 months
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