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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
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE February 2, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Suicide Events [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collaborative Adolescent Research on Emotions and Suicide
Official Title  ICMJE Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Suicidal and Self-injurious Behaviour
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Dialectical Behavior Therapy
    Intervention: Behavioral: Dialectical Behavior Therapy
  • Active Comparator: Inidividual and Group Supportive Therapy
    Intervention: Behavioral: Individual and Group Supportive Therapy
Publications * McCauley E, Berk MS, Asarnow JR, Adrian M, Cohen J, Korslund K, Avina C, Hughes J, Harned M, Gallop R, Linehan MM. Efficacy of Dialectical Behavior Therapy for Adolescents at High Risk for Suicide: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Aug 1;75(8):777-785. doi: 10.1001/jamapsychiatry.2018.1109. Erratum in: JAMA Psychiatry. 2018 Aug 1;75(8):867.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2016)
173
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
170
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528020
Other Study ID Numbers  ICMJE 41565-C
R01MH090159-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marsha Linehan, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • Seattle Children's Hospital
  • University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
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
PRS Account University of Washington
Verification Date May 2016

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