This trial is active, not recruiting.
|Conditions||substance-related disorders, mental health|
|Phase||phase 2/phase 3|
|Sponsor||University of Miami|
|Start date||July 2013|
|End date||December 2017|
|Trial size||172 participants|
|Trial identifier||NCT02702193, 20111132|
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.
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
PROMIS depression scale
time frame: 7 days
Female participants from 18 years up to 65 years old.
- 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
|Official title||Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children|
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