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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

173 participants

Primary outcome timeframe

baseline, 4, 8 and 12 months

Results posted on

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

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

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: Intent to Treat analysis

Self-reported Daily Smoking as measured by the Addiction Severity Index.

Outcome measures

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 months

Population: Intent to Treat analysis

Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.

Outcome measures

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 months

Population: Intent to Treat analysis

Self-reported Illicit Drug Use as measured by the Addiction Severity Index.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment As Usual (TAU)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Victoria Mitrani

University of Miami

Phone: 305 284-9139

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place