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Concurrent Treatment for Depressed Parents and DepressedAdolescents

Primary Purpose

Depression, Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Concurrent treatment
Adolescent treatment only
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Suicidal Ideation, Suicide Attempts

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent treatment

Adolescent treatment only

Arm Description

Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.

Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2009
Last Updated
August 4, 2015
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00951821
Brief Title
Concurrent Treatment for Depressed Parents and DepressedAdolescents
Official Title
Concurrent Treatment for Parents and Adolescents Who Attempt Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicide
Keywords
Suicidal Ideation, Suicide Attempts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concurrent treatment
Arm Type
Experimental
Arm Description
Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Arm Title
Adolescent treatment only
Arm Type
Active Comparator
Arm Description
Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Concurrent treatment
Other Intervention Name(s)
CBT for adolescents and parents
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adolescent treatment only
Intervention Description
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
Primary Outcome Measure Information:
Title
Beck Depression Inventory - Adolescent Report, Change in Symptom Level
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Beck Suicide Scale - Adolescent Response
Description
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.
Time Frame
Measured at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Concurrent Treatment for Depressed Parents and DepressedAdolescents

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