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Parent Psychoeducation and Cognitive Behavior Therapy for Latino Adolescents With Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by National Institute of Mental Health (NIMH).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118469
First Posted: July 11, 2005
Last Update Posted: April 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Mental Health (NIMH)
  Purpose
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.

Condition Intervention Phase
Depression Behavioral: Psychoeducation Behavioral: Cognitive behavior therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Parent Psychoeducation Intervention in CBT for Depressed Latino Youth

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • General functioning status
  • family functioning
  • school attendance
  • attrition rates

Estimated Enrollment: 144
Study Start Date: July 2004
Estimated Study Completion Date: December 2008
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of depression
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Psychiatric conditions other than depression
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118469


Contacts
Contact: Guillermo Bernal, PhD gbernal@uprrp.edu

Locations
Puerto Rico
University Center for Psychological Services and Research, University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00926
Contact: Guillermo Bernal       gbernal@uprrp.edu   
Principal Investigator: Guillermo Bernal, PhD         
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Guillermo Bernal, PhD University Center for Psychological Services and Research, University of Puerto Rico
  More Information

ClinicalTrials.gov Identifier: NCT00118469     History of Changes
Other Study ID Numbers: R01MH067893 ( U.S. NIH Grant/Contract )
DSIR 84-CTS
First Submitted: July 6, 2005
First Posted: July 11, 2005
Last Update Posted: April 3, 2008
Last Verified: February 2008

Keywords provided by National Institute of Mental Health (NIMH):
Adolescent
CBT
Parents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders