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Treatment for Depressed Preadolescent Girls

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00061698
First Posted: June 4, 2003
Last Update Posted: June 12, 2015
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):
University of Texas at Austin
  Purpose
This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.

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

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Texas at Austin:

Enrollment: 153
Study Start Date: April 2002
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 )
DSIR 84-CTS
First Submitted: June 3, 2003
First Posted: June 4, 2003
Last Update Posted: June 12, 2015
Last Verified: June 2015

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