Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury (IPT-ASI)

This study has been completed.
Sponsor:
Collaborator:
MINT: Mental Health Initiative
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00401102
First received: November 15, 2006
Last updated: December 20, 2012
Last verified: December 2012
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Depression
Self-injurious Behavior
Intervention: Behavioral: Interpersonal Psychotherapy for Depressed Adolescents

  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
No text entered.

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
Group 1 All participants recieved Interpersonal psychotherapy

Participant Flow:   Overall Study
    Group 1  
STARTED     12  
COMPLETED     5  
NOT COMPLETED     7  



  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
Group 1 All participants recieved Interpersonal psychotherapy

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     12  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.5  ± 1.3  
Gender  
[units: participants]
 
Female     9  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Self-Injurious Thoughts and Behaviors Interview   [ Time Frame: 8 weeks ]

2.  Primary:   CGI   [ Time Frame: 1 week ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Primary:   C-GAS   [ Time Frame: 1 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Primary:   CDRS   [ Time Frame: 1 week ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Primary:   Self-injury Monitoring Card   [ Time Frame: 1 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Beck Depression Inventory   [ Time Frame: 2 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Multidimensional Anxiety Scale for Children   [ Time Frame: recently ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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:  
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: Dr. Colleen Jacobsonn
Organization: Iona College
phone: 646-207-3563
e-mail: cjacobson@iona.edu


No publications provided


Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00401102     History of Changes
Other Study ID Numbers: 5332
Study First Received: November 15, 2006
Results First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board