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Trial record 66 of 136 for:    (domestic or partner) AND (violence OR abuse)

SET-Recovery/Healthy Home (SET-R)

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ClinicalTrials.gov Identifier: NCT02702193
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Victoria Mitrani, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Substance-Related Disorders
Mental Health
Intervention Behavioral: SET-R/Healthy Home
Enrollment 173
Recruitment Details  
Pre-assignment Details Screening: 243 were screened of which there were 70 excluded (9 did not meet inclusion criteria; 32 declined participation; 29 were lost contacts)
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Period Title: Baseline Assessment/Randomization
Started 86 87
Completed 85 87
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: 4 Month Follow up
Started 86 87
Completed 68 69
Not Completed 18 18
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             17             18
Period Title: 8 Month Follow up
Started 86 87
Completed 71 69
Not Completed 15 18
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             14             18
Period Title: 12 Month Follow up
Started 86 87
Completed 69 69
Not Completed 17 18
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             16             18
Arm/Group Title SET-R/Healthy Home Treatment as Usual (TAU) Total
Hide Arm/Group Description

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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. Total of all reporting groups
Overall Number of Baseline Participants 85 87 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 87 participants 172 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
85
 100.0%
87
 100.0%
172
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 87 participants 172 participants
Female
85
 100.0%
87
 100.0%
172
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 85 participants 87 participants 172 participants
Hispanic
65
  76.5%
72
  82.8%
137
  79.7%
Black
13
  15.3%
9
  10.3%
22
  12.8%
White Non Hispanic
7
   8.2%
6
   6.9%
13
   7.6%
1.Primary Outcome
Title Trajectory of Depression of Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Above Clinical Cutoff: Baseline
40
  47.1%
28
  32.2%
Participants Above Clinical Cutoff: 4 month
18
  21.2%
27
  31.0%
Participants Above Clinical Cutoff: 8 month
25
  29.4%
23
  26.4%
Participants Above Clinical Cutoff: 12 month
21
  24.7%
23
  26.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SET-R/Healthy Home, Treatment As Usual (TAU)
Comments To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén & Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Generalized Estimating Equations (GEE)
Comments GEE allowed the examination of trajectories from baseline through the 12 month follow-up.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
2.Primary Outcome
Title Trajectory of Anxiety of Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Above Clinical Cutoff: Baseline
49
  57.6%
48
  55.2%
Participants Above Clinical Cutoff: 4 month
37
  43.5%
36
  41.4%
Participants Above Clinical Cutoff: 8 month
32
  37.6%
31
  35.6%
Participants Above Clinical Cutoff: 12 month
26
  30.6%
32
  36.8%
3.Secondary Outcome
Title Trajectory of Sleep Disturbance of Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Above Clinical Cutoff: Baseline
30
  35.3%
28
  32.2%
Participants Above Clinical Cutoff: 4 month
24
  28.2%
17
  19.5%
Participants Above Clinical Cutoff: 8 month
16
  18.8%
25
  28.7%
Participants Above Clinical Cutoff: 12 month
13
  15.3%
19
  21.8%
4.Secondary Outcome
Title Trajectory of Fatigue of Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Above Clinical Cutoff: Baseline
25
  29.4%
27
  31.0%
Participants Above Clinical Cutoff: 4 month
20
  23.5%
24
  27.6%
Participants Above Clinical Cutoff: 8 month
24
  28.2%
18
  20.7%
Participants Above Clinical Cutoff: 12 month
16
  18.8%
20
  23.0%
5.Secondary Outcome
Title Trajectory of Pain Experienced by Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Above Clinical Cutoff: Baseline
24
  28.2%
30
  34.5%
Participants Above Clinical Cutoff: 4 month
18
  21.2%
26
  29.9%
Participants Above Clinical Cutoff: 8 month
19
  22.4%
21
  24.1%
Participants Above Clinical Cutoff: 12 month
17
  20.0%
24
  27.6%
6.Secondary Outcome
Title Trajectory of Physical Function of Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Better than Clinical Cutoff: Baseline
65
  76.5%
65
  74.7%
Participants Better than Clinical Cutoff: 4 month
51
  60.0%
48
  55.2%
Participants Better than Clinical Cutoff: 8 month
50
  58.8%
53
  60.9%
Participants Better than Clinical Cutoff: 12 month
58
  68.2%
49
  56.3%
7.Secondary Outcome
Title Trajectory of Oral Health Problems of Participants
Hide Description 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.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with More than 2 Problems: Baseline
44
  51.8%
45
  51.7%
Participants with More than 2 Problems: 4 month
33
  38.8%
33
  37.9%
Participants with More than 2 Problems: 8 month
30
  35.3%
28
  32.2%
Participants with More than 2 Problems: 12 month
26
  30.6%
19
  21.8%
8.Secondary Outcome
Title Trajectory of Daily Smoking of Participants
Hide Description Self-reported Daily Smoking as measured by the Addiction Severity Index.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Participants who smoked in last 30 days: Baseline
21
  24.7%
21
  24.1%
Participants who smoked in last 30 days: 4 month
16
  18.8%
17
  19.5%
Participants who smoked in last 30 days: 8 month
16
  18.8%
16
  18.4%
Participants who smoked in last 30 days: 12 month
14
  16.5%
18
  20.7%
9.Secondary Outcome
Title Trajectory of Alcohol Intoxication of Participants
Hide Description Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Number intoxicated in last 30 days: Baseline
4
   4.7%
3
   3.4%
Number intoxicated in last 30 days: 4 month
4
   4.7%
4
   4.6%
Number intoxicated in last 30 days: 8 month
7
   8.2%
4
   4.6%
Number intoxicated in last 30 days: 12 month
4
   4.7%
7
   8.0%
10.Secondary Outcome
Title Trajectory of Illicit Drug Use of Participants
Hide Description Self-reported Illicit Drug Use as measured by the Addiction Severity Index.
Time Frame baseline, 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description:

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Number who used drugs in last 30 days: Baseline
12
  14.1%
8
   9.2%
Number who used drugs in last 30 days: 4 month
7
   8.2%
5
   5.7%
Number who used drugs in last 30 days: 8 month
7
   8.2%
3
   3.4%
Number who used drugs in last 30 days: 12 month
9
  10.6%
4
   4.6%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SET-R/Healthy Home Treatment As Usual (TAU)
Hide Arm/Group Description

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.

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. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.

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.
All-Cause Mortality
SET-R/Healthy Home Treatment As Usual (TAU)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/87 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
SET-R/Healthy Home Treatment As Usual (TAU)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/87 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SET-R/Healthy Home Treatment As Usual (TAU)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/87 (0.00%)