Collaborative Adolescent Research on Emotions and Suicide

NCT ID: NCT01528020

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Suicidal and Self-injurious Behaviour

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dialectical Behavior Therapy

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy

Intervention Type: 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.

Inidividual and Group Supportive Therapy

Group Type: ACTIVE_COMPARATOR

Individual and Group Supportive Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Marsha Linehan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marsha M Linehan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Elizabeth A McCauley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Joan Asarnow

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Michele Berk, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Harbor UCLA

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38325518 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35122952 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33677832 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33539915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29926087 (View on PubMed)

Related Links

http://depts.washington.edu/brtc/

Related Info

http://www.harboruclapsych.com

Related Info

Other Identifiers

R01MH090159-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

41565-C

Identifier Type: -

Identifier Source: org_study_id