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. 2015 Dec 21;2015(12):CD012013. doi: 10.1002/14651858.CD012013

Linehan 2014.

Study name Collaborative Adolescent Research on Emotions and Suicide (CARES).
Trial Registration Number: NCT01528020.
Methods Allocation: single‐blind randomisation.
Design: multi‐centre (community clinics).
Setting: community outpatient clinics.
Location: Seattle, WA and Los Angeles, CA, USA.
Participants Males and females, between 12 and 18 years of age, diagnosed with emotional dysregulation, who made a suicide attempt and/or engaged in self‐harm within 6 months prior to randomisation will be eligible for inclusion in this study.
Interventions Individuals randomised to the experimental group will receive dialectical behavior therapy and individual and group supportive therapy.
Outcomes Primary outcomes: repetition of any suicidal behaviour, defined as a suicide attempt, suicide, or self‐injury with suicide intent or ambivalent intent as measured by the SASII, admission to the emergency department or inpatient psychiatric facilities for suicidality as measured by the Columbia Classification Algorithm of Suicide Assessment, days successfully retained in treatment, and quality of family relationships as measured by the child bipolar questionnaire.
Secondary outcomes: number of episodes of non‐suicidal self‐injury as measured by the SASII, the highest medical risk and risk/rescue score as measured by the SASII, number of suicidal threats made measured by the Suicide Behaviors Questionnaire‐Revised, and the level of suicidal ideation as measured by the Suicide Ideation Questionnaire‐Junior, number who drop‐out of treatment prematurely, number of treatment sessions attended, number of times late to treatment sessions, number of times treatment sessions left early, scores on the adolescent global functioning scale of the Children's Global Assessment Scale, scores on the depression scale of the Children's Depression Inventory, scores on the anger control, bullying, emotional self‐control, aggression, emotion regulation, and resiliency scales of the Behavior Assessment System for Children, Second Edition, Buss Perry Aggression Questionnaire, and Difficulties in Emotion Regulation Scale, scores on the impulsiveness and substance abuse scales of the Barratt Impulsiveness Scale, and the Daily Drinking Questionnaire, scores on the social adjustment scale of the Social Adjustment Scale–Self‐Report, and school attendance as measured by school records.
Starting date January, 2012.
Proposed End Date: January, 2016.
Contact information Name: Prof. Marsha M. Linehan (PI).
Affiliation: Behavioural Research and Therapy Clinics, University of Washington.
email:linehan@uw.edu
Notes Ms. Elaine Franks, personal assistant to Marsha Linehan, very kindly provided unpublished information relating to this trial. Ms. Franks also provided the following note about this trial:
"...insufficient males have been enrolled and will be removed from the final data set and later presented as a sub‐study."

NSSI: non‐suicidal self injury
SASII: Suicide Attempt Self Injury Interview