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Treatment for Depressed Preadolescent Girls

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ClinicalTrials.gov Identifier: NCT00061698
Recruitment Status : Completed
First Posted : June 4, 2003
Last Update Posted : June 12, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive Behavior Therapy Child Only Behavioral: CBT plus Parent Training Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CBT vs CBT Plus Parent Training for Girls With Depression
Study Start Date : April 2002
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cognitive Behavior Therapy Child Only
Participants completed 20 sessions of CBT
Behavioral: Cognitive Behavior Therapy Child Only
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
Active Comparator: CBT plus Parent training
Child participants completed 20 sessions of CBT and parents completed 8 sessions of parent training
Behavioral: Cognitive Behavior Therapy Child Only
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
Behavioral: CBT plus Parent Training
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior.
No Intervention: Minimal Contact Control
Participants waited 12 weeks for treatment but their safety and well-being were monitored during this time




Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Publications of Results:
Morey, M. E., Arora, P., & Stark, K. D. (in press). Multiple-Stage Screening of Youth Depression in Schools. Psychology in the Schools.

Other Publications:
Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT00061698     History of Changes
Other Study ID Numbers: R01MH063998 ( U.S. NIH Grant/Contract )
R01MH063998 ( U.S. NIH Grant/Contract )
DSIR 84-CTS
First Posted: June 4, 2003    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders