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OpenTrials
Completed

NCT Number: NCT00061698

Treatment for Depressed Preadolescent Girls

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

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Key information

Age range

9 year–13 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy Child Only

Behavioral

Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.

CBT plus Parent Training

Behavioral

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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

CBT vs CBT Plus Parent Training for Girls With Depression

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2003
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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