Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Concurrent Treatment for Depressed Parents and DepressedAdolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00951821
First received: August 3, 2009
Last updated: July 28, 2014
Last verified: July 2014

August 3, 2009
July 28, 2014
July 2009
December 2013   (final data collection date for primary outcome measure)
Depression [ Time Frame: Measured at baseline, post-treatment, and after 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00951821 on ClinicalTrials.gov Archive Site
Suicidal ideation and behavior [ Time Frame: Measured at baseline, post-treatment, and after 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Concurrent Treatment for Depressed Parents and DepressedAdolescents
Concurrent Treatment for Parents and Adolescents Who Attempt Suicide

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Suicide
  • Behavioral: Concurrent cognitive behavioral therapy (CBT)
    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
  • Behavioral: Adolescent only cognitive behavioral therapy (CBT)
    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
  • Experimental: Concurrent treatment
    Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
    Intervention: Behavioral: Concurrent cognitive behavioral therapy (CBT)
  • Active Comparator: Adolescent treatment only
    Only adolescent participants will receive cognitive behavioral therapy.
    Intervention: Behavioral: Adolescent only cognitive behavioral therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00951821
R34 MH082211, R34MH082211, DSIR 84 CTS
Yes
Anthony Spirito, National Institute of Mental Health (NIMH)
Brown University
National Institute of Mental Health (NIMH)
Principal Investigator: Anthony Spirito, PhD Brown University
Brown University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP