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临床试验/NCT02702193
NCT02702193已完成不适用

Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children

University of Miami2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
2
主要终点
Trajectory of Depression of Participants

研究概览

简要总结

The study conducts a community-based randomized trial comparing an adaptation of Structural Ecosystems Therapy (SET), "Healthy Home", as an enhancement of substance abuse or mental health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172 Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or mental health services. The study is conducted with a community partner, Banyan Health Systems, that delivers substance abuse/mental health treatment and primary care. Data is collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2) test the effectiveness of Healthy Home for improving health and mental health outcomes of children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care, environmental risk, family functioning and stigma); 4) assess implementation and sustainability factors and the relationship between fidelity and outcomes; and 5) examine the interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a manualized, strength-based, directive and process oriented family ecosystemic home health intervention developed to address the needs of mothers and their children affected by substance abuse and other mental health disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Enrolled in outpatient substance abuse or mental health treatment (or treatment for substance abuse as a co-occurring disorder) or case management for mental health or substance abuse problems,
  • have at least one child age 0-17 with whom she has at least monthly contact
  • be age 18 or above,
  • capable of giving informed consent and comprehending either English or Spanish,
  • willing and able to participate fully in the protocol

排除标准

  • Persons who do not meet the inclusion criteria listed above will be excluded.

结局指标

主要结局

Trajectory of Depression of Participants

时间窗: baseline, 4, 8 and 12 months

Self-reported experience with depressive symptoms as measured by the PROMIS depression scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.

Trajectory of Anxiety of Participants

时间窗: baseline, 4, 8 and 12 months

Self-reported experience with anxiety symptoms as measured by the PROMIS anxiety scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.

次要结局

  • Trajectory of Illicit Drug Use of Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Sleep Disturbance of Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Fatigue of Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Pain Experienced by Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Physical Function of Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Oral Health Problems of Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Daily Smoking of Participants(baseline, 4, 8 and 12 months)
  • Trajectory of Alcohol Intoxication of Participants(baseline, 4, 8 and 12 months)

研究者

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

Victoria Mitrani

Professor

University of Miami

研究点 (2)

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相似试验

SET-Recovery/Healthy Home | 临床试验