跳至主要内容
临床试验/NCT06560866
NCT06560866
招募中
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 266 人2023年11月24日

概览

阶段
不适用
干预措施
Just Care for Families
疾病 / 适应症
Social Determinants of Health
发起方
Chestnut Health Systems
入组人数
266
试验地点
1
主要终点
Change in opioid use
状态
招募中
最后更新
29天前

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/).

注册库
clinicaltrials.gov
开始日期
2023年11月24日
结束日期
2028年1月30日
最后更新
29天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Lisa Saldana

Research Scientist

Chestnut Health Systems

入排标准

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

Parents receiving Just Care for Families

干预措施: Just Care for Families

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))

研究点 (1)

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