SET-Recovery/Healthy Home

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance-Related Disorders, Mental Health

Intervention / Treatment
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* Behavioral: SET-R/Healthy Home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Persons who do not meet the inclusion criteria listed above will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SET-R/Healthy Home<br>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. | Behavioral: SET-R/Healthy Home<br>* 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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.<br>|
| No Intervention: TAU<br>Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trajectory of Depression of Participants | 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. | baseline, 4, 8 and 12 months | 
| Trajectory of Anxiety of Participants | 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. | baseline, 4, 8 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trajectory of Sleep Disturbance of Participants | 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. | baseline, 4, 8 and 12 months | 
| Trajectory of Fatigue of Participants | 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. | baseline, 4, 8 and 12 months | 
| Trajectory of Pain Experienced by Participants | 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. | baseline, 4, 8 and 12 months | 
| Trajectory of Physical Function of Participants | 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. | baseline, 4, 8 and 12 months | 
| Trajectory of Oral Health Problems of Participants | 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. | baseline, 4, 8 and 12 months | 
| Trajectory of Daily Smoking of Participants | Self-reported Daily Smoking as measured by the Addiction Severity Index. | baseline, 4, 8 and 12 months | 
| Trajectory of Alcohol Intoxication of Participants | Self-reported Alcohol Intoxication as measured by the Addiction Severity Index. | baseline, 4, 8 and 12 months | 
| Trajectory of Illicit Drug Use of Participants | Self-reported Illicit Drug Use as measured by the Addiction Severity Index. | baseline, 4, 8 and 12 months |