Preventing Parental Opioid and/or Methamphetamine Addiction Within DHS-Involved Families: PRE-FAIR
概览
- 阶段
- 不适用
- 干预措施
- Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)
- 疾病 / 适应症
- Opioid-Related Disorders
- 发起方
- Chestnut Health Systems
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Completion of Key Intervention Implementation Activities Over the Course of the Study
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
The Families Actively Improving Relationships (FAIR) program is a recently developed, rigorously evaluated, intensive outpatient treatment program for parents involved in the child welfare system for parental opioid and/or amphetamine type substance use disorder-methamphetamine (OUD; MUD). Outcomes from the FAIR effectiveness trial suggest the potential for FAIR to be adapted as a prevention program for parents involved with child welfare and self-sufficiency systems, and to be implemented in counties with low service availability and access. This exploratory-developmental phased project dedicates a year of activities toward collaborating with Oregon state Department of Human Services (DHS) partners and leadership to develop a plan for adaptation, recruitment, and implementation of FAIR for prevention (PRE-FAIR). The investigative team-with expertise in intervention development and clinical effectiveness trials, implementation science, decision science, health economics, and including DHS leadership-will work in collaboration with the Coordinating Center to develop strategies to identify, reach, and engage parents involved in the DHS system, aged 16 to 30, who are at-risk for escalation of misuse or development of OUD and/or MUD; and develop and adapt FAIR to prevent initiation of opioid and/or methamphetamine misuse and escalation to disorder. Following the completion of a set of concrete milestones during the first year, the project will conduct a Hybrid I randomized clinical trial, to evaluate the PRE-FAIR program and its implementation. Across two counties, parents referred by DHS for opioid or methamphetamine use or misuse with risk for escalation (n = 240), will be recruited and followed longitudinally for 24 months. Parents will be randomized to receive PRE-FAIR or standard case management and referral (STAND). Overarching goals of this study phase are to test the effectiveness of the adaptations designed in the previous phase and to build upon state collaborations-specifically, to: Evaluate the effectiveness of PRE-FAIR in preventing DHS-involved parents, aged 16 to 30, from initiating misuse or escalating opioid and/or methamphetamine use; Examine and assess the implementation of PRE-FAIR in the county-driven DHS system to inform sustainability plans; and Assess the implementation and intervention costs associated with the adoption of PRE-FAIR. Outcomes from this project will inform further refinement of protocols and the potential for broader scale-up of PRE-FAIR.
研究者
Lisa Saldana
Senior Research Scientist
Chestnut Health Systems
入排标准
入选标准
- •Risk for opioid or methamphetamine misuse or escalation of use
- •Parent of a child 0-
- •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.
排除标准
- •Used methamphetamines or opioids 4 or more times in past year
- •Active diagnosis of a methamphetamine or opioid use disorder
研究组 & 干预措施
PRE-FAIR
Participants in this arm will receive the PRE-FAIR intervention.
干预措施: Prevention Adaptation of Families Actively Improving Relationships (PRE-FAIR)
Control
Participants in this arm will receive services standard case management and services .
干预措施: Standard Case Management and Referral
结局指标
主要结局
Completion of Key Intervention Implementation Activities Over the Course of the Study
时间窗: Duration of the study, up to 4 years
Measure of implementation progress as measured by the Stages of Implementation Completion (SIC).
Mean changes in parent drug cravings and stress as measured by the Parent Daily Report
时间窗: Baseline, monthly for 18-months post-Baseline, 24-months post-Baseline
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.
Costs Associated with Key Intervention Implementation Activities Over the Course of the Study
时间窗: Duration of the study, up to 4 years
Implementation costs associated with adoption of PRE-FAIR as measured by the Cost of Implementing New Strategies (COINS).
Change in opioid or methamphetamine use measured from Baseline to 24 months post-baseline
时间窗: Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline
Any opioid or methamphetamine use in the past 30 days measured by the Addiction Severity Index
Mean changes in behavioral health services utilization
时间窗: up to 24- months
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.
次要结局
- Mean Levels of Client Satisfaction with Services at the End of Treatment(End of treatment, average of 9 months)
- Descriptive Measures of FAIR Program Delivery(Duration of the study, up to 4 years)
- 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)
- Mean changes in post-traumatic stress and psychological effects of trauma as measured by the Trauma Symptom Inventory-2 (TSI-2)(Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline)
- Mean Changes in Mental Health Symptoms from Baseline to 24-months Post-Baseline(Baseline to 24-months Post-Baseline)
- Mean changes in parenting stress as measured by Parenting Stress Inventory(Baseline; 4-, 8-, 12-, 18-, and 24- months post Baseline)