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
  Purpose

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 Intervention Phase
Depression
Suicide
Behavioral: Concurrent cognitive behavioral therapy (CBT)
Behavioral: Adolescent only cognitive behavioral therapy (CBT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Concurrent Treatment for Parents and Adolescents Who Attempt Suicide

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured at baseline, post-treatment, and after 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Suicidal ideation and behavior [ Time Frame: Measured at baseline, post-treatment, and after 12 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concurrent treatment
Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
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
Active Comparator: Adolescent treatment only
Only adolescent participants will receive cognitive behavioral therapy.
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951821

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
  More Information

No publications provided

Responsible Party: Anthony Spirito, Professor, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00951821     History of Changes
Other Study ID Numbers: R34 MH082211, R34MH082211, DSIR 84 CTS
Study First Received: August 3, 2009
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Brown University:
Suicidal Ideation
Suicide Attempts

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

ClinicalTrials.gov processed this record on October 19, 2014