Collaborative Adolescent Research on Emotions and Suicide (CARES)

• ClinicalTrials.gov Identifier: NCT01528020
• Recruitment Status: Completed
• First Posted: February 7, 2012
• Last Update Posted: May 17, 2016
• Sponsor: University of Washington
• Collaborators: Seattle Children's Hospital; University of California, Los Angeles; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Marsha Linehan, University of Washington

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: January 2012
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: May 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.

Outcome Measures

Primary Outcome Measures :

1. Suicide Events [ Time Frame: 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Washington

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

More Information

Additional Information:

Related Info 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: JAMA Psychiatry. 2018 Aug 1;75(8):867.

• Responsible Party: Marsha Linehan, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01528020
• Other Study ID Numbers: 41565-C; R01MH090159-01A1 ( U.S. NIH Grant/Contract )
• First Posted: February 7, 2012
• Last Update Posted: May 17, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Self-Injurious Behavior; Behavioral Symptoms