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

Collaborative Adolescent Research on Emotions and Suicide (CARES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Seattle Children's Hospital
University of California, Los Angeles
Information provided by (Responsible Party):
Marsha Linehan, University of Washington
ClinicalTrials.gov Identifier:
NCT01528020
First received: February 2, 2012
Last updated: November 6, 2014
Last verified: November 2014

February 2, 2012
November 6, 2014
January 2012
June 2015   (final data collection date for primary outcome measure)
Suicide Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01528020 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collaborative Adolescent Research on Emotions and Suicide
Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation

Suicide is the third leading cause of death among adolescents in the US yet there is a paucity of research on effective treatments for this population. The primary aim of the research described in this application is to evaluate the efficacy of dialectical behavior therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal adults of reducing the incidence, frequency and medical risk of suicide attempts and non-suicidal self-injuries among individuals meeting criteria for borderline personality disorder (BPD). While DBT is widely used in the community with suicidal adolescents, particularly those with difficulties characteristic of BPD such as poor emotion regulation and impulse control, no randomized trial of DBT with suicidal adolescents has ever been conducted. And, while non-randomized trials indicate that the intervention is both safe and effective, without a randomized trial the investigators simply do not know whether DBT for suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of alternative treatments for high risk adolescents, addressing this question is of great importance. The second aim of the research is to analyze mediators of reduced suicidal and self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both treatments include 6 months of individual and group treatment and adolescents and a parent complete 5 assessments over a 1-year period.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Suicidal and Self-injurious Behaviour
  • Behavioral: Dialectical Behavior Therapy
    DBT is a cognitive behavioral approach to treatment that synthesizes change based strategies characteristic of behavior therapy and validation strategies consistent with acceptance based treatments through application of dialectical principles and techniques. Based on a combined capability deficit and motivational model which states that 1) adolescents with suicidal behaviors and borderline features lack important interpersonal, self-regulation and distress tolerance skills, and 2) personal and environmental factors often both block and/or inhibit use of behavioral skills that adolescents do have, and at times reinforce dysfunctional behaviors. The primary adaptation for adolescents is the inclusion of family in the DBT skills training portion of therapy as well as a much greater inclusion of parents in the management of high suicide risk.
  • Behavioral: Individual and Group Supportive Therapy
    The aim of IGST is relief or reduction of symptoms, the promotion of personal growth including enhancement of adolescents' strengths/coping skills and capacity to use environmental supports and to help suicidal adolescents increase their sense of self-esteem. Treatment aims to reduce suicidal behavior and emotion dysregulation by helping the adolescent learn to trust and validate themselves. The overarching assumption in IGST is that adolescents become suicidal for a variety of reasons, but they often report feeling isolated, misunderstood, unloved and unwanted. IGST Interventions include providing a strong therapeutic alliance where the therapist provides an environment that is completely trusting and validating to counter the experience of the depressed/suicidal youth.
  • Experimental: Dialectical Behavior Therapy
    Intervention: Behavioral: Dialectical Behavior Therapy
  • Active Comparator: Inidividual and Group Supportive Therapy
    Intervention: Behavioral: Individual and Group Supportive Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
May 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Current suicide ideation;
  2. More than one intentional self-injury or suicide attempt;
  3. Has difficulties with emotion and impulsive behavior or has characteristics similar to borderline personality disorder;
  4. 13-17 years of age;
  5. At least one family member or responsible adult available to participate in assessments and treatment.

Exclusion Criteria:

  • Has significant developmental delays
  • Has significant current mania, psychosis or life threatening anorexia
  • Has a court order for treatment
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01528020
41565-C, R01MH090159-01A1
Yes
Marsha Linehan, University of Washington
University of Washington
  • Seattle Children's Hospital
  • University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
Principal Investigator: Marsha M Linehan, Ph.D. University of Washington
Principal Investigator: Elizabeth A McCauley, Ph.D. Seattle Children's Hospital
Principal Investigator: Joan Asarnow University of California, Los Angeles
Principal Investigator: Michele Berk, Ph.D. Harbor UCLA
University of Washington
November 2014

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