Collaborative Adolescent Research on Emotions and Suicide

Suicidal and Self-injurious Behaviour Clinical Trial

— CARES  

Official title:

Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528020
• Other study ID #: 41565-C
• Secondary ID: R01MH090159-01A1
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: May 16, 2016
• Start date: January 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: May 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicidal and Self-injurious Behaviour

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), Seattle Children's Hospital, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Events		1 year	Yes

External Links

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