Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Evaluation of Treatments for Homeless Youths

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Natasha Slesnick, Ohio State University
ClinicalTrials.gov Identifier:
NCT01143792
First received: June 11, 2010
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
Results First Received: December 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment ended on time, recruitment completed as proposed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
intent to treat design used.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    CRA + HIV Prevention     MET + HIV Prevention     Case Management + HIV Prevention  
STARTED     93     86     91  
COMPLETED     93     86     91  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The number of participants in each group varies because the urn randomization program didn't balance the groups equally.

Reporting Groups
  Description
CRA + HIV Prevention Treatment included twelve 1-hour sessions for a total of 14 sessions.
MET + HIV Prevention Treatment included two 1-hour MI sessions for a total of 4 sessions
Case Management + HIV Prevention Treatment included twelve 1-hour sessions for a total of 14 sessions.
Total Total of all reporting groups

Baseline Measures
    CRA + HIV Prevention     MET + HIV Prevention     Case Management + HIV Prevention     Total  
Number of Participants  
[units: participants]
 		  93     86     91     270  
Age  
[units: participants]
 		       
<=18 years     17     16     10     43  
Between 18 and 65 years     76     70     81     227  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  18.70  ± 1.34     18.69  ± 1.32     18.84  ± 1.11     18.7  ± 1.3  
Gender  
[units: participants]
 		       
Female     43     37     47     127  
Male     50     49     44     143  
Region of Enrollment  
[units: participants]
 		       
United States     93     86     91     270  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Substance Use   [ Time Frame: Three months ]
  Show Outcome Measure 1

2.  Primary:   Substance Use   [ Time Frame: Six months ]
  Show Outcome Measure 2

3.  Primary:   Substance Use   [ Time Frame: Twelve months ]
  Show Outcome Measure 3

4.  Secondary:   HIV Risk   [ Time Frame: Three months ]
  Show Outcome Measure 4

5.  Secondary:   HIV Risk   [ Time Frame: Six months ]
  Show Outcome Measure 5

6.  Secondary:   HIV Risk   [ Time Frame: Twelve months ]
  Show Outcome Measure 6

7.  Secondary:   Depressive Symptoms   [ Time Frame: Three months ]
  Show Outcome Measure 7

8.  Secondary:   Depressive Symptoms   [ Time Frame: Six months ]
  Show Outcome Measure 8

9.  Secondary:   Depressive Symptoms   [ Time Frame: Twelve months ]
  Show Outcome Measure 9


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Overall Study
Additional Description Adverse events were monitored but none were observed.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
CRA + HIV Prevention Treatment included twelve 1-hour sessions for a total of 14 sessions.
MET + HIV Prevention Treatment included two 1-hour MI sessions for a total of 4 sessions
Case Management + HIV Prevention Treatment included twelve 1-hour sessions for a total of 14 sessions.

Other Adverse Events
    CRA + HIV Prevention     MET + HIV Prevention     Case Management + HIV Prevention  
Total, other (not including serious) adverse events        
# participants affected / at risk     0/93 (0.00%)     0/86 (0.00%)     0/91 (0.00%)  



  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Show More Information