Supported Education Pilot (SEd)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01073657
First received: February 18, 2010
Last updated: February 13, 2015
Last verified: February 2015
Results First Received: December 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[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: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01073657     History of Changes
Other Study ID Numbers: PPO 09-254
Study First Received: February 18, 2010
Results First Received: December 10, 2014
Last Updated: February 13, 2015
Health Authority: United States: Federal Government