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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00118469
Other study ID # R01MH067893
Secondary ID DSIR 84-CTS
Status Recruiting
Phase Phase 2
First received July 6, 2005
Last updated April 1, 2008
Start date July 2004
Est. completion date December 2008

Study information

Verified date February 2008
Source National Institute of Mental Health (NIMH)
Contact Guillermo Bernal, PhD
Email gbernal@uprrp.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness of adding a parent-involved intervention to cognitive behavior therapy in reducing depressive symptoms among Latino adolescents with depression.


Description:

Adolescent depression can have a devastating impact on social, emotional, and family functioning. Cognitive behavior therapy (CBT) is the most common treatment for depression; however, not all patients respond adequately to CBT. In addition, data on the effects of CBT among ethnic minorities are limited. Because Latinos are the largest minority group in the United States, the development of treatments specifically designed for depressed Latino youth are needed. This study will determine whether adding a psychoeducation intervention with parent involvement will be more effective in reducing depressive symptoms among Latino adolescents than treatment with CBT alone.

The treatment phase of this study will last 12 weeks. Participants will be randomly assigned to receive 12 weeks of either CBT alone or CBT with psychoeducation. The psychoeducation will consist of 8 sessions over the 12-week treatment period. During the sessions, participants and their parents will be given detailed information about depression and ways the condition can be treated. They will also be taught coping skills and ways to recognize a relapse. CBT sessions will take place weekly during the study. During the sessions, a therapist will work with participants to modify the behavior and thinking patterns that cause and are associated with their depressive symptoms. Both participants and their parents will undergo interviews at study start, study completion, and 3, 9, and 15 months after study completion. During the interviews, participants' depressive symptoms, school attendance, and overall functional status will be assessed. Parents' stress levels and work attendance will also be assessed. At Months 6 and 12 after study completion, participants and their parents will complete questionnaires to assess any relapses in depressive symptoms.

Study hypothesis: Active treatment with psychoeducation will be superior to no psychoeducation in reducing depression post-treatment. Because the psychoeducation intervention is designed to involve parents and thus impact other aspects of the family system, the treatment is expected to produce better outcomes in several functional domains.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

- Diagnosis of depression

- Parent or guardian willing to provide informed consent

Exclusion Criteria:

- Psychiatric conditions other than depression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychoeducation

Cognitive behavior therapy


Locations

Country Name City State
Puerto Rico University Center for Psychological Services and Research, University of Puerto Rico San Juan

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary General functioning status
Primary family functioning
Primary school attendance
Primary attrition rates
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