NCT01528020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

February 2, 2012

Last Update Submit

May 16, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicide Events

    1 year

Study Arms (2)

Dialectical Behavior Therapy

EXPERIMENTAL
Behavioral: Dialectical Behavior Therapy

Inidividual and Group Supportive Therapy

ACTIVE COMPARATOR
Behavioral: Individual and Group Supportive Therapy

Interventions

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.

Dialectical Behavior 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.

Inidividual and Group Supportive Therapy

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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;
  • years of age;
  • At least one family member or responsible adult available to participate in assessments and treatment.

You may not qualify if:

  • Has significant developmental delays
  • Has significant current mania, psychosis or life threatening anorexia
  • Has a court order for treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98125, United States

Location

Related Publications (5)

  • Berk MS, Gallop R, Asarnow JR, Adrian MC, Hughes JL, McCauley E. Remission, Recovery, Relapse, and Recurrence Rates for Suicide Attempts and Nonsuicidal Self-Injury for Suicidal Youth Treated With Dialectical Behavior Therapy or Supportive Therapy. J Am Acad Child Adolesc Psychiatry. 2024 Sep;63(9):888-897. doi: 10.1016/j.jaac.2024.01.012. Epub 2024 Feb 5.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 7, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2015

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations