Clinical trial NCT01528020: Collaborative Adolescent Research on Emotions and Suicide
Official title: Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal and Self-injurious Behaviour
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2012-02-07
Enrollment: 173
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Suicide Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Washington
name: Marsha M Linehan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Elizabeth A McCauley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Joan Asarnow
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbor UCLA
name: Michele Berk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.