Treatment for Depressed Preadolescent Girls

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Behavioral: CBT plus Parent Training; Behavioral: Cognitive Behavior Therapy Child Only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00061698

DSIR 84-CTS

R01MH063998 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 153 patients

Sex: Female

Ages: 9 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 3 patient groups

Cognitive Behavior Therapy Child Only

Active Comparator group

Description:

Participants completed 20 sessions of CBT

Treatment:

Behavioral: Cognitive Behavior Therapy Child Only

CBT plus Parent training

Active Comparator group

Description:

Child participants completed 20 sessions of CBT and parents completed 8 sessions of parent training

Treatment:

Behavioral: CBT plus Parent Training

Behavioral: Cognitive Behavior Therapy Child Only

Minimal Contact Control

No Intervention group

Description:

Participants waited 12 weeks for treatment but their safety and well-being were monitored during this time