CARES: Collaborative Adolescent Research on Emotions and Suicide

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT01528020

Collaborator

Seattle Children's Hospital (Other), University of California, Los Angeles (Other), National Institute of Mental Health (NIMH) (NIH)

173

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal and Self-injurious Behaviour	Behavioral: Dialectical Behavior Therapy Behavioral: Individual and Group Supportive Therapy	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Suicide Events [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Marsha Linehan, Professor, University of Washington

ClinicalTrials.gov Identifier:

NCT01528020

Other Study ID Numbers:

41565-C
R01MH090159-01A1

First Posted:

Feb 7, 2012

Last Update Posted:

May 17, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Self-Injurious Behavior

Study Results

No Results Posted as of May 17, 2016