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Collaborative Adolescent Research on Emotions and Suicide (CARES)

Primary Purpose

Suicidal and Self-injurious Behaviour

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
Individual and Group Supportive Therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal and Self-injurious Behaviour

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dialectical Behavior Therapy

Inidividual and Group Supportive Therapy

Arm Description

Outcomes

Primary Outcome Measures

Suicide Events

Secondary Outcome Measures

Full Information

First Posted
February 2, 2012
Last Updated
May 16, 2016
Sponsor
University of Washington
Collaborators
Seattle Children's Hospital, University of California, Los Angeles, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01528020
Brief Title
Collaborative Adolescent Research on Emotions and Suicide
Acronym
CARES
Official Title
Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Seattle Children's Hospital, University of California, Los Angeles, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal and Self-injurious Behaviour

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behavior Therapy
Arm Type
Experimental
Arm Title
Inidividual and Group Supportive Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual and Group Supportive Therapy
Intervention Description
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 Measure Information:
Title
Suicide Events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current suicide ideation; More than one intentional self-injury or suicide attempt; Has difficulties with emotion and impulsive behavior or has characteristics similar to borderline personality disorder; 13-17 years of age; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marsha M Linehan, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth A McCauley, Ph.D.
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Asarnow
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michele Berk, Ph.D.
Organizational Affiliation
Harbor UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98125
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35122952
Citation
Berk MS, Gallop R, Asarnow JR, Adrian M, Avina C, Hughes JL, Korslund KE, McCauley E. Trajectories of Treatment Response and Nonresponse in Youth at High Risk for Suicide. J Am Acad Child Adolesc Psychiatry. 2022 Sep;61(9):1119-1130. doi: 10.1016/j.jaac.2022.01.010. Epub 2022 Feb 2.
Results Reference
derived
PubMed Identifier
33677832
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
Results Reference
derived
PubMed Identifier
33539915
Citation
Asarnow JR, Berk MS, Bedics J, Adrian M, Gallop R, Cohen J, Korslund K, Hughes J, Avina C, Linehan MM, McCauley E. Dialectical Behavior Therapy for Suicidal Self-Harming Youth: Emotion Regulation, Mechanisms, and Mediators. J Am Acad Child Adolesc Psychiatry. 2021 Sep;60(9):1105-1115.e4. doi: 10.1016/j.jaac.2021.01.016. Epub 2021 Feb 1.
Results Reference
derived
PubMed Identifier
29926087
Citation
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.
Results Reference
derived
Links:
URL
http://depts.washington.edu/brtc/
Description
Related Info
URL
http://www.harboruclapsych.com
Description
Related Info

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Collaborative Adolescent Research on Emotions and Suicide

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