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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
  Purpose

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 Intervention
Suicidal and Self-injurious Behaviour
Behavioral: Dialectical Behavior Therapy
Behavioral: Individual and Group Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Suicide Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: January 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01528020

Locations
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
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Marsha Linehan, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01528020     History of Changes
Other Study ID Numbers: 41565-C, R01MH090159-01A1
Study First Received: February 2, 2012
Last Updated: November 6, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 24, 2014