Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children
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
- 是
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
Victoria Mitrani
Professor
University of Miami
