N/A
N=173
SET-Recovery/Healthy Home
Substance-Related Disorders · Mental Health
Bottom Line
View on ClinicalTrials.gov: NCT02702193 ↗Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Trajectory of Depression of Participants — 40; 28; 18; 27 Participants — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SET-R/Healthy Home (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Miami
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trajectory of Depression of Participants |
40; 28; 18; 27; 25; 23 | <.05 sig |
| PRIMARY Trajectory of Anxiety of Participants |
49; 48; 37; 36; 32; 31 | — |
| SECONDARY Trajectory of Sleep Disturbance of Participants |
30; 28; 24; 17; 16; 25 | — |
| SECONDARY Trajectory of Fatigue of Participants |
25; 27; 20; 24; 24; 18 | — |
| SECONDARY Trajectory of Pain Experienced by Participants |
24; 30; 18; 26; 19; 21 | — |
| SECONDARY Trajectory of Physical Function of Participants |
65; 65; 51; 48; 50; 53 | — |
| SECONDARY Trajectory of Oral Health Problems of Participants |
44; 45; 33; 33; 30; 28 | — |
| SECONDARY Trajectory of Daily Smoking of Participants |
21; 21; 16; 17; 16; 16 | — |
| SECONDARY Trajectory of Alcohol Intoxication of Participants |
4; 3; 4; 4; 7; 4 | — |
| SECONDARY Trajectory of Illicit Drug Use of Participants |
12; 8; 7; 5; 7; 3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02702193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.