Treatment for Depressed Preadolescent Girls - Tabular View

Tracking Information
First Received Date ^ICMJE	June 3, 2003
Last Updated Date	February 5, 2007
Start Date ^ICMJE	April 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00061698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Treatment for Depressed Preadolescent Girls
Official Title ^ICMJE	CBT vs CBT Plus Parent Training for Girls With Depression
Brief Summary	This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.
Detailed Description	Depressive disorders during childhood are virulent, long-lasting disorders that are a risk factor for the development of future depressive episodes and other psychiatric difficulties. A dysfunctional family environment is a possible pathway to the development of depression in adolescents. The family environment is an especially salient context for the development of depression in preadolescent girls. Depression is expressed differently between male and female adolescents; girls may not benefit as much as boys from treatments such as cognitive behavioral therapy (CBT) because the treatments may not target disturbances and skills that are specific to preadolescent girls. This study will identify effective treatments for depression in preadolescent girls. Depressed participants are randomly assigned to receive CBT, CBT plus parent training (PT), or a minimal contact control (MCC). The CBT group receives treatment twice a week for 10 weeks. Participants in the CBT plus PT group receive therapy sessions and group treatment for 10 weeks. Participants in the MCC group meet with a research associate once a week for 10 weeks. During the control visits, the child's depressive symptoms are assessed, but no advice or treatment is given. Participants are assessed at baseline, post-treatment, and at yearly follow-up visits for up to 4 years. School performance, home environment, and the impact of the interventions on parent adjustment are evaluated.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Depression
Intervention ^ICMJE	Behavioral: Cognitive Behavioral Therapy Behavioral: Parent Training
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	150
Completion Date	April 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Depressive Disorder Exclusion Criteria: Learning disability or limited intellectual ability Health-related illness that would prevent the patient from completing the research study
Gender	Female
Ages	9 Years to 13 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00061698
Responsible Party
Study ID Numbers ^ICMJE	R01 MH63998, DSIR 84-CTS
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	February 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP