We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Collaborative Adolescent Research on Emotions and Suicide (CARES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01528020
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : May 17, 2016
Seattle Children's Hospital
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Marsha Linehan, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Suicidal and Self-injurious Behaviour Behavioral: Dialectical Behavior Therapy Behavioral: Individual and Group Supportive Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation
Study Start Date : January 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

Arm Intervention/treatment
Experimental: Dialectical Behavior Therapy 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.

Active Comparator: Inidividual and Group Supportive Therapy 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.

Primary Outcome Measures :
  1. Suicide Events [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01528020

Layout table for location information
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98125
Sponsors and Collaborators
University of Washington
Seattle Children's Hospital
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Layout table for investigator information
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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marsha Linehan, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01528020    
Other Study ID Numbers: 41565-C
R01MH090159-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Self-Injurious Behavior
Behavioral Symptoms