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Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00338806
First Posted: June 20, 2006
Last Update Posted: August 15, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: June 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Bipolar Disorder
Depression
Interventions: Behavioral: Interpersonal psychotherapy for prevention with adolescents
Behavioral: Educational clinical monitoring

  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
Recruitment dates:10/06-5/10 Location: New York State Psychiatric Institute (mental health research and patient care)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled subjects were excluded from the trial because they were found to be either too symptomatic or asymptomatic

Reporting Groups
  Description
Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.

Participant Flow for 2 periods

Period 1:   Acute Phase
    Interpersonal Psychotherapy for Prevention   Educational Clinical Monitoring
STARTED   2   5 
COMPLETED   2   4 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 

Period 2:   Follow-up
    Interpersonal Psychotherapy for Prevention   Educational Clinical Monitoring
STARTED   2   4 
COMPLETED   1   1 
NOT COMPLETED   1   3 
Lost to Follow-up                1                3 



  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.
No text entered.

Reporting Groups
  Description
IPT- Prevention for Adolescents

Participants will receive interpersonal psychotherapy for prevention with adolescents

Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.

Educational and Clinical Monitoring

Participants will receive educational clinical monitoring

Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.

Total Total of all reporting groups

Baseline Measures
   IPT- Prevention for Adolescents   Educational and Clinical Monitoring   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   5   7 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      2 100.0%      5 100.0%      7 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  50.0%      2  40.0%      3  42.9% 
Male      1  50.0%      3  60.0%      4  57.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      2 100.0%      5 100.0%      7 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2   5   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   K SADS-Present Version (KSADS-P)   [ Time Frame: 12 weeks ]

2.  Primary:   K SADS-Present Version (KSADS-P)   [ Time Frame: 6 months ]

3.  Primary:   K SADS-Present Version (KSADS-P)   [ Time Frame: 12 months ]

4.  Primary:   K SADS-Present Version (KSADS-P)   [ Time Frame: 18 months ]

5.  Primary:   Children's Depression Rating Scale-Revised (CDRS-R)   [ Time Frame: Week 12 ]

6.  Primary:   Children's Depression Rating Scale-Revised (CDRS-R)   [ Time Frame: 6 months ]

7.  Primary:   Children's Depression Rating Scale-Revised (CDRS-R)   [ Time Frame: 12 months ]

8.  Primary:   Children's Depression Rating Scale-Revised (CDRS-R)   [ Time Frame: 18 months ]

9.  Primary:   Children's Global Assessment Scale (C-GAS)   [ Time Frame: Week 12 ]

10.  Primary:   Children's Global Assessment Scale (C-GAS)   [ Time Frame: 6 months ]

11.  Primary:   Children's Global Assessment Scale (C-GAS)   [ Time Frame: 12 months ]

12.  Primary:   Children's Global Assessment Scale (C-GAS)   [ Time Frame: 18 months ]

13.  Primary:   Young Mania Rating Scale (YMRS)   [ Time Frame: Week 12 ]

14.  Primary:   Young Mania Rating Scale (YMRS)   [ Time Frame: 6 months ]

15.  Primary:   Young Mania Rating Scale (YMRS)   [ Time Frame: 12 months ]

16.  Primary:   Young Mania Rating Scale (YMRS)   [ Time Frame: 18 months ]

17.  Secondary:   Attitudes Toward Treatment Questionnaire   [ Time Frame: Measured at Week 12 ]

18.  Secondary:   Emotion Regulation Questionnaire   [ Time Frame: Measured at Week 12 ]

19.  Secondary:   Emotion Regulation Questionnaire   [ Time Frame: 6 months ]

20.  Secondary:   Emotion Regulation Questionnaire   [ Time Frame: 12 months and 18 months ]

21.  Secondary:   Family Assessment Device   [ Time Frame: Measured at Week 12 ]

22.  Secondary:   Family History Screen   [ Time Frame: Measured at Week 1 (baseline) ]

23.  Secondary:   Mood Disorder Questionnaire   [ Time Frame: Week 1 ]

24.  Secondary:   Patient Health Questionnaire   [ Time Frame: Measured at Week 1 ]

25.  Secondary:   Social Adjustment Scale - Self Report for Adolescents   [ Time Frame: Measured at Week 12 ]

26.  Secondary:   Social Adjustment Scale - Self Report for Adolescents   [ Time Frame: 12 months and 18 months ]

27.  Secondary:   Social Rhythm Metric Short Form   [ Time Frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment ]

28.  Secondary:   Treatment Credibility Scale   [ Time Frame: Measured at Week 1 ]


  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
Limitations include a very small sample size due to recruitment difficulty. In addition, participation with follow-up evaluations was poor.


  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. Helen Verdeli
Organization: NYSPInstitute
phone: 212 543 5262
e-mail: verdelih@nyspi.columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00338806     History of Changes
Other Study ID Numbers: #5067
K23MH071530 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2006
First Posted: June 20, 2006
Results First Submitted: June 14, 2016
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017



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