Clinical trial NCT00061698: Treatment for Depressed Preadolescent Girls
Official title: CBT vs CBT Plus Parent Training for Girls With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-06-04
Enrollment: 153
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cole DA, Cai L, Martin NC, Findling RL, Youngstrom EA, Garber J, Curry JF, Hyde JS, Essex MJ, Compas BE, Goodyer IM, Rohde P, Stark KD, Slattery MJ, Forehand R. Structure and measurement of depression in youths: applying item response theory to clinical data. Psychol Assess. 2011 Dec;23(4):819-33. doi: 10.1037/a0023518. Epub 2011 May 2.
citation: Stark, K. D. (2008). Experiences Implementing the ACTION Treatment Program: Implications for Preventive Interventions. Clinical Psychology: Science and Practice, 15, 342 - 345.
citation: Stapleton LM, Sander JB, Stark KD. Psychometric properties of the Beck Depression Inventory for Youth in a sample of girls. Psychol Assess. 2007 Jun;19(2):230-5. doi: 10.1037/1040-3590.19.2.230.
citation: Morey, M. E., Arora, P., & Stark, K. D. (in press). Multiple-Stage Screening of Youth Depression in Schools. Psychology in the Schools.