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Evaluation of Treatments for Homeless Youths

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ClinicalTrials.gov Identifier: NCT01143792
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Natasha Slesnick, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Substance Abuse
Interventions Behavioral: Community Reinforcement Approach (CRA) + HIV prevention
Behavioral: Case Management + HIV Prevention
Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention
Enrollment 270

Recruitment Details recruitment ended on time, recruitment completed as proposed.
Pre-assignment Details intent to treat design used.
Arm/Group Title CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention
Hide Arm/Group Description Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions. Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions. Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
Period Title: Overall Study
Started 93 86 91
Completed 93 86 91
Not Completed 0 0 0
Arm/Group Title CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention Total
Hide Arm/Group Description Treatment included twelve 1-hour sessions for a total of 14 sessions. Treatment included two 1-hour MI sessions for a total of 4 sessions Treatment included twelve 1-hour sessions for a total of 14 sessions. Total of all reporting groups
Overall Number of Baseline Participants 93 86 91 270
Hide Baseline Analysis Population Description
The number of participants in each group varies because the urn randomization program didn't balance the groups equally.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 86 participants 91 participants 270 participants
<=18 years
17
  18.3%
16
  18.6%
10
  11.0%
43
  15.9%
Between 18 and 65 years
76
  81.7%
70
  81.4%
81
  89.0%
227
  84.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 86 participants 91 participants 270 participants
18.70  (1.34) 18.69  (1.32) 18.84  (1.11) 18.7  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 86 participants 91 participants 270 participants
Female
43
  46.2%
37
  43.0%
47
  51.6%
127
  47.0%
Male
50
  53.8%
49
  57.0%
44
  48.4%
143
  53.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 93 participants 86 participants 91 participants 270 participants
93 86 91 270
1.Primary Outcome
Title Substance Use
Hide Description Percentage of substance use days in prior three months.
Time Frame Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MET + HIV Prevention CRA + HIV Prevention Case Management + HIV Prevention
Hide Arm/Group Description:
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
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.
The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
Overall Number of Participants Analyzed 66 70 66
Mean (Standard Deviation)
Unit of Measure: percent days of drug use
45.67  (43.24) 53.60  (40.76) 49.38  (40.66)
2.Primary Outcome
Title Substance Use
Hide Description Percentage of substance use days in prior three months
Time Frame Six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 70 68 66
Mean (Standard Deviation)
Unit of Measure: percent days of drug use
39.10  (38.83) 48.88  (41.43) 42.64  (40.74)
3.Primary Outcome
Title Substance Use
Hide Description Percentage of substance use days in prior six months
Time Frame Twelve months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MET + HIV Prevention Case Management + HIV Prevention CRA + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 69 64 71
Mean (Standard Deviation)
Unit of Measure: percent days of drug use
49.25  (41.55) 44.33  (39.31) 38.46  (39.84)
4.Secondary Outcome
Title HIV Risk
Hide Description Frequency of condoms use in prior three months.
Time Frame Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Case Management + HIV Prevention CRA + HIV Prevention MET + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 58 66 57
Measure Type: Number
Unit of Measure: participants who always used condom
19 26 25
5.Secondary Outcome
Title HIV Risk
Hide Description Frequency of condoms use in prior three months.
Time Frame Six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Case Management + HIV Prevention MET + HIV Prevention CRA + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 58 62 65
Measure Type: Number
Unit of Measure: participants who always used condoms
25 29 25
6.Secondary Outcome
Title HIV Risk
Hide Description Frequency of condoms use in prior six months.
Time Frame Twelve months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Case Management + HIV Prevention MET + HIV Prevention CRA + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 53 59 63
Measure Type: Number
Unit of Measure: participants who always used condoms
17 18 24
7.Secondary Outcome
Title Depressive Symptoms
Hide Description Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
Time Frame Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Case Management + HIV Prevention CRA + HIV Prevention MET + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 66 70 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.63  (9.57) 14.78  (14.83) 10.97  (12.20)
8.Secondary Outcome
Title Depressive Symptoms
Hide Description Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Time Frame Six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Case Management + HIV Prevention CRA + HIV Prevention MET + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 66 70 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.02  (9.94) 11.97  (14.13) 8.76  (10.09)
9.Secondary Outcome
Title Depressive Symptoms
Hide Description Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
Time Frame Twelve months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Case Management + HIV Prevention CRA + HIV Prevention MET + HIV Prevention
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 64 71 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.70  (11.09) 12.07  (12.13) 8.48  (10.93)
Time Frame Overall Study
Adverse Event Reporting Description Adverse events were monitored but none were observed.
 
Arm/Group Title CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention
Hide Arm/Group Description Treatment included twelve 1-hour sessions for a total of 14 sessions. Treatment included two 1-hour MI sessions for a total of 4 sessions Treatment included twelve 1-hour sessions for a total of 14 sessions.
All-Cause Mortality
CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/86 (0.00%)   0/91 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CRA + HIV Prevention MET + HIV Prevention Case Management + HIV Prevention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/86 (0.00%)   0/91 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Natasha Slesnick
Organization: The Ohio State University
Phone: 614 247-8469
Responsible Party: Natasha Slesnick, Ohio State University
ClinicalTrials.gov Identifier: NCT01143792     History of Changes
Other Study ID Numbers: 2005B0078
R01DA013549 ( U.S. NIH Grant/Contract )
First Submitted: June 11, 2010
First Posted: June 14, 2010
Results First Submitted: December 13, 2012
Results First Posted: April 16, 2013
Last Update Posted: April 16, 2013