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Concurrent Treatment for Depressed Parents and DepressedAdolescents

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ClinicalTrials.gov Identifier: NCT00951821
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony Spirito, Brown University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Depression Suicide Behavioral: Concurrent treatment Behavioral: Adolescent treatment only Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Concurrent Treatment for Parents and Adolescents Who Attempt Suicide
Study Start Date : July 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Concurrent treatment
Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
 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.
Other Name: CBT for adolescents and parents
Active Comparator: Adolescent treatment only
Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
 Behavioral: 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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Beck Depression Inventory - Adolescent Report, Change in Symptom Level [ Time Frame: 12 months ]
    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 :
  1. Beck Suicide Scale - Adolescent Response [ Time Frame: Measured at 12 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00951821


Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT00951821     History of Changes
Other Study ID Numbers: R34MH082211 ( U.S. NIH Grant/Contract )
DSIR 84 CTS
First Posted: August 4, 2009    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015
Last Verified: March 2015

Keywords provided by Anthony Spirito, Brown University:
Suicidal Ideation
Suicide Attempts

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms