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Completed

NCT Number: NCT01528020

Collaborative Adolescent Research on Emotions and Suicide

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98125, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical behavior therapy

Behavioral

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

Behavioral

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 outcomes

  1. Suicide Events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation

Acronym: CARES

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 7, 2012
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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