Parent Psychoeducation and Cognitive Behavior Therapy for Latino Adolescents With Depression

Depression Clinical Trial

Official title:

Parent Psychoeducation Intervention in CBT for Depressed Latino Youth

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
• 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

• Depression

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