SET-Recovery/Healthy Home

Not Applicable

Completed

• Conditions: Mental Health; Substance-Related Disorders
• Interventions: Behavioral: SET-R/Healthy Home

• Registration Number: NCT02702193
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2018-10-02
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-30
• Last Update Submitted: 2018-11-30
• Results First Posted: 2018-12-20
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 173

Inclusion Criteria

1. 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,
2. have at least one child age 0-17 with whom she has at least monthly contact
3. be age 18 or above,
4. capable of giving informed consent and comprehending either English or Spanish,
5. willing and able to participate fully in the protocol

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SET-R/Healthy Home	SET-R/Healthy Home	SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.

Primary Outcome Measures

Name	Time	Method
Trajectory of Depression of Participants	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	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.

Secondary Outcome Measures

Name	Time	Method
Trajectory of Illicit Drug Use of Participants	baseline, 4, 8 and 12 months	Self-reported Illicit Drug Use as measured by the Addiction Severity Index.
Trajectory of Sleep Disturbance of Participants	baseline, 4, 8 and 12 months	Self-reported experience with sleep disturbance over the past 7 days as measured by the PROMIS 29 sleep disturbance subscale . Each item is scored 1-5, yielding a total between 4 and 20.
Trajectory of Fatigue of Participants	baseline, 4, 8 and 12 months	Self-reported experience with fatigue over the past 7 days as measured by the PROMIS 29 fatigue subscale. Each item is scored 1-5, yielding a total between 5 and 20.
Trajectory of Pain Experienced by Participants	baseline, 4, 8 and 12 months	Self-reported experience with pain over the past 7 days as measured by the PROMIS 29 pain subscale. Each item is scored 1-5, yielding a total between 5 and 25.
Trajectory of Physical Function of Participants	baseline, 4, 8 and 12 months	Self-reported physical function over the past 7 days as measured by the PROMIS 29 physical function subscale. Each item is scored 1-5, yielding a total between 4 and 20, with higher scores indicating better physical function.
Trajectory of Oral Health Problems of Participants	baseline, 4, 8 and 12 months	Self-reported oral health as measured by the Oral Health Impact Profile. Each item is scored 1-5, yielding a total between 14 and 70.
Trajectory of Daily Smoking of Participants	baseline, 4, 8 and 12 months	Self-reported Daily Smoking as measured by the Addiction Severity Index.
Trajectory of Alcohol Intoxication of Participants	baseline, 4, 8 and 12 months	Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States