Trial Outcomes & Findings for Evaluation of Treatments for Homeless Youths (NCT NCT01143792)
NCT ID: NCT01143792
Last Updated: 2013-04-16
Results Overview
Percentage of substance use days in prior three months.
COMPLETED
PHASE2
270 participants
Three months
2013-04-16
Participant Flow
recruitment ended on time, recruitment completed as proposed.
intent to treat design used.
Participant milestones
| Measure |
CRA + HIV Prevention
Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
|
MET + HIV Prevention
Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.
|
Case Management + HIV Prevention
Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
86
|
91
|
|
Overall Study
COMPLETED
|
93
|
86
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Treatments for Homeless Youths
Baseline characteristics by cohort
| Measure |
CRA + HIV Prevention
n=93 Participants
Treatment included twelve 1-hour sessions for a total of 14 sessions.
|
MET + HIV Prevention
n=86 Participants
Treatment included two 1-hour MI sessions for a total of 4 sessions
|
Case Management + HIV Prevention
n=91 Participants
Treatment included twelve 1-hour sessions for a total of 14 sessions.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
227 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age Continuous
|
18.70 years
STANDARD_DEVIATION 1.34 • n=99 Participants
|
18.69 years
STANDARD_DEVIATION 1.32 • n=107 Participants
|
18.84 years
STANDARD_DEVIATION 1.11 • n=206 Participants
|
18.7 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
143 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=99 Participants
|
86 participants
n=107 Participants
|
91 participants
n=206 Participants
|
270 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Three monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Percentage of substance use days in prior three months.
Outcome measures
| Measure |
MET + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=70 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
Substance Use
|
45.67 percent days of drug use
Standard Deviation 43.24
|
53.60 percent days of drug use
Standard Deviation 40.76
|
49.38 percent days of drug use
Standard Deviation 40.66
|
PRIMARY outcome
Timeframe: Six monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Percentage of substance use days in prior three months
Outcome measures
| Measure |
MET + HIV Prevention
n=70 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=68 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
Substance Use
|
39.10 percent days of drug use
Standard Deviation 38.83
|
48.88 percent days of drug use
Standard Deviation 41.43
|
42.64 percent days of drug use
Standard Deviation 40.74
|
PRIMARY outcome
Timeframe: Twelve monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
Percentage of substance use days in prior six months
Outcome measures
| Measure |
MET + HIV Prevention
n=69 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=64 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=71 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
Substance Use
|
49.25 percent days of drug use
Standard Deviation 41.55
|
44.33 percent days of drug use
Standard Deviation 39.31
|
38.46 percent days of drug use
Standard Deviation 39.84
|
SECONDARY outcome
Timeframe: Three monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Frequency of condoms use in prior three months.
Outcome measures
| Measure |
MET + HIV Prevention
n=58 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=57 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
HIV Risk
|
19 participants who always used condom
|
26 participants who always used condom
|
25 participants who always used condom
|
SECONDARY outcome
Timeframe: Six monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Frequency of condoms use in prior three months.
Outcome measures
| Measure |
MET + HIV Prevention
n=58 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=62 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=65 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
HIV Risk
|
25 participants who always used condoms
|
29 participants who always used condoms
|
25 participants who always used condoms
|
SECONDARY outcome
Timeframe: Twelve monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Frequency of condoms use in prior six months.
Outcome measures
| Measure |
MET + HIV Prevention
n=53 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=59 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=63 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
HIV Risk
|
17 participants who always used condoms
|
18 participants who always used condoms
|
24 participants who always used condoms
|
SECONDARY outcome
Timeframe: Three monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
Outcome measures
| Measure |
MET + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=70 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
Depressive Symptoms
|
9.63 units on a scale
Standard Deviation 9.57
|
14.78 units on a scale
Standard Deviation 14.83
|
10.97 units on a scale
Standard Deviation 12.20
|
SECONDARY outcome
Timeframe: Six monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Outcome measures
| Measure |
MET + HIV Prevention
n=66 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=70 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=68 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
Depressive Symptoms
|
10.02 units on a scale
Standard Deviation 9.94
|
11.97 units on a scale
Standard Deviation 14.13
|
8.76 units on a scale
Standard Deviation 10.09
|
SECONDARY outcome
Timeframe: Twelve monthsPopulation: The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
Outcome measures
| Measure |
MET + HIV Prevention
n=64 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
CRA + HIV Prevention
n=71 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
|
Case Management + HIV Prevention
n=69 Participants
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
|
|---|---|---|---|
|
Depressive Symptoms
|
8.70 units on a scale
Standard Deviation 11.09
|
12.07 units on a scale
Standard Deviation 12.13
|
8.48 units on a scale
Standard Deviation 10.93
|
Adverse Events
CRA + HIV Prevention
MET + HIV Prevention
Case Management + HIV Prevention
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