Treatment for Depressed Preadolescent Girls

NCT ID: NCT00061698

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavior Therapy Child Only

Participants completed 20 sessions of CBT

Group Type: ACTIVE_COMPARATOR

Cognitive Behavior Therapy Child Only

Intervention Type: BEHAVIORAL

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

CBT plus Parent training

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

Group Type: ACTIVE_COMPARATOR

Cognitive Behavior Therapy Child Only

Intervention Type: BEHAVIORAL

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

CBT plus Parent Training

Intervention Type: 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.

Minimal Contact Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavior Therapy Child Only

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 21534696 (View on PubMed)

Stark, K. D. (2008). Experiences Implementing the ACTION Treatment Program: Implications for Preventive Interventions. Clinical Psychology: Science and Practice, 15, 342 - 345.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17563204 (View on PubMed)

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

Reference Type: RESULT

Other Identifiers

R01MH063998

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTS

Identifier Type: -

Identifier Source: secondary_id

R01MH063998

Identifier Type: NIH

Identifier Source: org_study_id

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