跳至主要内容
临床试验/NCT06560866
NCT06560866进行中(未招募)不适用

Disrupting Social Risk Factors of Health to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions

Chestnut Health Systems1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2023年11月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
260
试验地点
1
主要终点
Change in opioid use

研究概览

简要总结

The study will evaluate the effectiveness of the Just Care for Families program in preventing Oregon Department of Human Services (ODHS)-involved parents in rural communities from escalating opioid and/or methamphetamine use and mental health disorders by disrupting the associated social risk factors of health (SRFOH). In addition, investigators will examine the impacts of SRFOH on Just Care treatment and the associated costs from the perspective of provider clinics delivering Just Care. Just Care is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. Just Care involves treatment components, supported by ongoing purposeful engagement: (1) Substance use treatment; (2) Mental health treatment; (3) Parent management training; (4) Community building; (5) Systems Navigation; and (6) Addressing basic needs. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).

详细描述

This study provides multiple tests of the mechanisms by which Just Care for Families disrupts the effects of lifetime social risk factors of health (SRFOH) on ultimate outcomes of preventing escalation of opioid and/or methamphetamine use and suicide (ideation, intention, attempts). Just Care for Families 's effect on these outcomes is hypothesized to occur through two mechanisms of action: (1) improvement in malleable SRFOH (direct targets of intervention) and (2) improvement in substance use and mental health problems (intermediate prevention outcomes). Analyses will examine whether the effects vary as a function of non-malleable external, structural SRFOH, such as community poverty and healthcare service availability. Additionally, system dynamics will be used to examine patterns of influence between SRFOH and Just Care for Families intervention targets, case outcomes, and associated costs. This study is supported by and included in the Helping to End Addiction Long-term Initiative (https://heal.nih.gov/).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Any substance misuse in the last year
  • Parent of a child, age 0-18
  • Resident of participating county (Lane, Linn, Benton, Douglas, Lincoln)
  • Insured by Oregon Health Plan (Medicaid)
  • Access to a computer or smartphone; or wireless/cellular connection if a device were to be provided; or reliable access to a landline to receive a brief weekly phone assessment in place of the digital assessment
  • Clinical Staff:
  • clinician at a participating clinic
  • Providing Just Care for Families services to parents in the study at any point during study

排除标准

  • Alcohol use disorder

研究组 & 干预措施

Just Care for Families

Experimental

Parents receiving Just Care for Families

干预措施: Just Care for Families (Behavioral)

结局指标

主要结局

Change in opioid use

时间窗: baseline, 9 months, and 18 months

Changes in any opioid use in past 30 days as assessed by Addiction Severity Index opioid use items (heroin, methadone, and other).

Change in methamphetamine use

时间窗: baseline, 9 months, 18 months

Changes in any methamphetamine use in past 30 days as assessed by Addiction Severity Index.

Change in depression severity

时间窗: Baseline, 9 months and 18 months

Changes in intensity of depression-related distress in the past week as measured by the Brief Symptom Inventory Depression Subscale items (Sum of responses to 6 Likert-type items, range 0-24).

Change in anxiety

时间窗: baseline, 9 months, 18 months

Changes in intensity of anxiety-related distress in the past week as measured by the Brief Symptom Inventory Anxiety Subscale items (Sum of responses to 6 Likert-type items, range 0-24).

Change in Social Risk Factors Needs

时间窗: Baseline through 18 months (weekly)

Changes in total number of needs or problems across Social Risk Factors of Health domains as assessed by PhenX toolkit items in a weekly parent survey. The number of items endorsed in the past week out of 43 items comprising 7 risk factor domains are scored. Domains include Work and money, neighborhood and transportation, education and training, food, community safety and support, healthcare system, internet and phone, and health and well-being.

次要结局

  • Changes in opioid or methamphetamine use as measured by Urinalysis testing(Baseline through 18 months (weekly))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Saldana

Research Scientist

Chestnut Health Systems

研究点 (1)

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