Trial Outcomes & Findings for SET-Recovery/Healthy Home (NCT NCT02702193)
NCT ID: NCT02702193
Last Updated: 2018-12-20
Results Overview
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.
COMPLETED
NA
173 participants
baseline, 4, 8 and 12 months
2018-12-20
Participant Flow
Screening: 243 were screened of which there were 70 excluded (9 did not meet inclusion criteria; 32 declined participation; 29 were lost contacts)
Participant milestones
| Measure |
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.
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 (TAU)
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.
|
|---|---|---|
|
Baseline Assessment/Randomization
STARTED
|
86
|
87
|
|
Baseline Assessment/Randomization
COMPLETED
|
85
|
87
|
|
Baseline Assessment/Randomization
NOT COMPLETED
|
1
|
0
|
|
4 Month Follow up
STARTED
|
86
|
87
|
|
4 Month Follow up
COMPLETED
|
68
|
69
|
|
4 Month Follow up
NOT COMPLETED
|
18
|
18
|
|
8 Month Follow up
STARTED
|
86
|
87
|
|
8 Month Follow up
COMPLETED
|
71
|
69
|
|
8 Month Follow up
NOT COMPLETED
|
15
|
18
|
|
12 Month Follow up
STARTED
|
86
|
87
|
|
12 Month Follow up
COMPLETED
|
69
|
69
|
|
12 Month Follow up
NOT COMPLETED
|
17
|
18
|
Reasons for withdrawal
| Measure |
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.
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 (TAU)
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.
|
|---|---|---|
|
Baseline Assessment/Randomization
Withdrawal by Subject
|
1
|
0
|
|
4 Month Follow up
Withdrawal by Subject
|
1
|
0
|
|
4 Month Follow up
Lost to Follow-up
|
17
|
18
|
|
8 Month Follow up
Withdrawal by Subject
|
1
|
0
|
|
8 Month Follow up
Lost to Follow-up
|
14
|
18
|
|
12 Month Follow up
Withdrawal by Subject
|
1
|
0
|
|
12 Month Follow up
Lost to Follow-up
|
16
|
18
|
Baseline Characteristics
SET-Recovery/Healthy Home
Baseline characteristics by cohort
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
65 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non Hispanic
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Depression of Participants
Participants Above Clinical Cutoff: 12 month
|
21 Participants
|
23 Participants
|
|
Trajectory of Depression of Participants
Participants Above Clinical Cutoff: Baseline
|
40 Participants
|
28 Participants
|
|
Trajectory of Depression of Participants
Participants Above Clinical Cutoff: 4 month
|
18 Participants
|
27 Participants
|
|
Trajectory of Depression of Participants
Participants Above Clinical Cutoff: 8 month
|
25 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Anxiety of Participants
Participants Above Clinical Cutoff: 4 month
|
37 Participants
|
36 Participants
|
|
Trajectory of Anxiety of Participants
Participants Above Clinical Cutoff: 8 month
|
32 Participants
|
31 Participants
|
|
Trajectory of Anxiety of Participants
Participants Above Clinical Cutoff: Baseline
|
49 Participants
|
48 Participants
|
|
Trajectory of Anxiety of Participants
Participants Above Clinical Cutoff: 12 month
|
26 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Sleep Disturbance of Participants
Participants Above Clinical Cutoff: Baseline
|
30 Participants
|
28 Participants
|
|
Trajectory of Sleep Disturbance of Participants
Participants Above Clinical Cutoff: 4 month
|
24 Participants
|
17 Participants
|
|
Trajectory of Sleep Disturbance of Participants
Participants Above Clinical Cutoff: 8 month
|
16 Participants
|
25 Participants
|
|
Trajectory of Sleep Disturbance of Participants
Participants Above Clinical Cutoff: 12 month
|
13 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Fatigue of Participants
Participants Above Clinical Cutoff: Baseline
|
25 Participants
|
27 Participants
|
|
Trajectory of Fatigue of Participants
Participants Above Clinical Cutoff: 4 month
|
20 Participants
|
24 Participants
|
|
Trajectory of Fatigue of Participants
Participants Above Clinical Cutoff: 8 month
|
24 Participants
|
18 Participants
|
|
Trajectory of Fatigue of Participants
Participants Above Clinical Cutoff: 12 month
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Pain Experienced by Participants
Participants Above Clinical Cutoff: Baseline
|
24 Participants
|
30 Participants
|
|
Trajectory of Pain Experienced by Participants
Participants Above Clinical Cutoff: 4 month
|
18 Participants
|
26 Participants
|
|
Trajectory of Pain Experienced by Participants
Participants Above Clinical Cutoff: 8 month
|
19 Participants
|
21 Participants
|
|
Trajectory of Pain Experienced by Participants
Participants Above Clinical Cutoff: 12 month
|
17 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Physical Function of Participants
Participants Better than Clinical Cutoff: Baseline
|
65 Participants
|
65 Participants
|
|
Trajectory of Physical Function of Participants
Participants Better than Clinical Cutoff: 4 month
|
51 Participants
|
48 Participants
|
|
Trajectory of Physical Function of Participants
Participants Better than Clinical Cutoff: 8 month
|
50 Participants
|
53 Participants
|
|
Trajectory of Physical Function of Participants
Participants Better than Clinical Cutoff: 12 month
|
58 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
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.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Oral Health Problems of Participants
Participants with More than 2 Problems: Baseline
|
44 Participants
|
45 Participants
|
|
Trajectory of Oral Health Problems of Participants
Participants with More than 2 Problems: 4 month
|
33 Participants
|
33 Participants
|
|
Trajectory of Oral Health Problems of Participants
Participants with More than 2 Problems: 8 month
|
30 Participants
|
28 Participants
|
|
Trajectory of Oral Health Problems of Participants
Participants with More than 2 Problems: 12 month
|
26 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
Self-reported Daily Smoking as measured by the Addiction Severity Index.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Daily Smoking of Participants
Participants who smoked in last 30 days: Baseline
|
21 Participants
|
21 Participants
|
|
Trajectory of Daily Smoking of Participants
Participants who smoked in last 30 days: 4 month
|
16 Participants
|
17 Participants
|
|
Trajectory of Daily Smoking of Participants
Participants who smoked in last 30 days: 8 month
|
16 Participants
|
16 Participants
|
|
Trajectory of Daily Smoking of Participants
Participants who smoked in last 30 days: 12 month
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Alcohol Intoxication of Participants
Number intoxicated in last 30 days: Baseline
|
4 Participants
|
3 Participants
|
|
Trajectory of Alcohol Intoxication of Participants
Number intoxicated in last 30 days: 4 month
|
4 Participants
|
4 Participants
|
|
Trajectory of Alcohol Intoxication of Participants
Number intoxicated in last 30 days: 8 month
|
7 Participants
|
4 Participants
|
|
Trajectory of Alcohol Intoxication of Participants
Number intoxicated in last 30 days: 12 month
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline, 4, 8 and 12 monthsPopulation: Intent to Treat analysis
Self-reported Illicit Drug Use as measured by the Addiction Severity Index.
Outcome measures
| Measure |
SET-R/Healthy Home
n=85 Participants
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 (TAU)
n=87 Participants
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.
|
|---|---|---|
|
Trajectory of Illicit Drug Use of Participants
Number who used drugs in last 30 days: Baseline
|
12 Participants
|
8 Participants
|
|
Trajectory of Illicit Drug Use of Participants
Number who used drugs in last 30 days: 4 month
|
7 Participants
|
5 Participants
|
|
Trajectory of Illicit Drug Use of Participants
Number who used drugs in last 30 days: 8 month
|
7 Participants
|
3 Participants
|
|
Trajectory of Illicit Drug Use of Participants
Number who used drugs in last 30 days: 12 month
|
9 Participants
|
4 Participants
|
Adverse Events
SET-R/Healthy Home
Treatment As Usual (TAU)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place