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Supported Education Pilot (SEd)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073657
First Posted: February 23, 2010
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: December 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: PTSD
Interventions: Other: Supported Education
Other: General Peer Support

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Veterans were referred to the study by clinicians and other sources such as Veterans Upward Program and were consented and baselined over a 9 month period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Supported Education Supported Education: Rehabilitation counseling using peers to achieve educational goals
General Peer Support Veterans received peer services that did not address educational goals

Participant Flow:   Overall Study
    Supported Education   General Peer Support
STARTED   17   16 
COMPLETED   17   16 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Arm 1 Supported Education: Rehabilitation counseling using peers to achieve educational goals
Active Control Veterans recived peer services that did not address educational goals
Total Total of all reporting groups

Baseline Measures
   Arm 1   Active Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   16   33 
Age 
[Units: Years]
Mean (Full Range)
 29 
 (23 to 37) 
 29 
 (21 to 36) 
 29 
 (21 to 37) 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   15   15   30 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   2   7 
White   12   14   26 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 


  Outcome Measures

1.  Primary:   "Supported Education Process Measure"   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marsha Langer Ellison, Ph.D.
Organization: Veterans Health Adminstration
phone: 781 687 3401
e-mail: Marsha.Ellison@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01073657     History of Changes
Other Study ID Numbers: PPO 09-254
First Submitted: February 18, 2010
First Posted: February 23, 2010
Results First Submitted: December 10, 2014
Results First Posted: February 18, 2015
Last Update Posted: April 28, 2015