Concurrent Treatment for Depressed Parents and DepressedAdolescents

Depression Clinical Trial

Official title:

Concurrent Treatment for Parents and Adolescents Who Attempt Suicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951821
• Other study ID #: R34MH082211
• Secondary ID: R34MH082211DSIR
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: August 4, 2015
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will develop an integrated treatment for adolescents who are depressed and suicidal and their parents who are depressed and have a history of suicidality.

Description:

Depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. Depression in parents, particularly mothers, may put the children at greater risk for depression. When an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. This study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality.

Participation in this study will last 6 months. Participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. For those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (CBT) counseling sessions and joint family counseling sessions. In the adolescent only treatment condition, adolescent participants will receive individual CBT sessions, but parents will not, and both will receive joint family sessions. Counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. CBT identifies and attempts to change problematic thought patterns. All participants will receive medication consultation if necessary.

Participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. These assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. At post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria for Adolescents:

• Lives at home with at least one parent or guardian

• Speaks English

• Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD)

Inclusion Criteria for Primary Caretakers:

• Speaks English

• Current diagnosis of MDD and a history of suicidality

Exclusion Criteria for Adolescents:

• Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam

• Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible)

• Only one adolescent per family is eligible

Exclusion Criteria for Primary Caretakers:

• Diagnosis of bipolar disorder or substance dependence

• If taking antidepressants, not on a stable dose for 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Suicide

Intervention

Behavioral:
• Concurrent treatment
Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment.
• Adolescent treatment only
Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory - Adolescent Report, Change in Symptom Level	self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression. The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.	12 months	No
Secondary	Beck Suicide Scale - Adolescent Response	measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation. These data refer to adolescent respondents. The outcome is a change score so range is from -38 to 38.	Measured at 12 months	No