A Study Examining Adolescents With Non-Suicidal Self-Injury

N/AActive Not RecruitingNCT02947308

University of Minnesota168 enrolled

Overview

This study will examine longitudinal brain development in young adolescent girls with a history of Non-Suicidal Self-Injury (NSSI). Specifically, three constructs outlined by the the Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a cognitive battery.

This study is designed to study brain development in 12-14 year old females with a history of NSSI. Assessments will take place over the course of three years, with three visits per year - a total of nine visits. The first visit will take place at the Ambulatory Research Center (ARC) at the Fairview Riverside hospital complex. This visit will include a number of questionnaires designed to gather information about the participant's physical and psychological health. Additionally, measures of intelligence quotient (IQ) and demographics will be assessed. The second visit will again take place at the ARC. For this visit, participants will be asked to partake in the Trier Social Stress Test (TSST) in which they prepare a short, five-minute speech and deliver the speech to an audience with an additional task to follow. The TSST will be videotaped. Following the completion of this task, the participant will complete computer tests in order to measure things like attention and memory. During the second visit, five saliva samples will be collected to measure levels of the hormone Cortisol. The participant will need to collect additional saliva samples at home. The third visit will take place at the University of Minnesota Center for Magnetic Resonance Research (CMRR) and will involve a brain MRI. Before the MRI the participant will be asked to provide a urine sample and complete a drug and pregnancy test. During the MRI, the participant will be asked to lie quietly in the scanner. The participant will do activities such as resting, listening to music, and playing games using a button box while in the scanner. The participant will need to come in to complete these assessments twice more at one and two years following the completion of the first set of visits - a total of nine visits overall.

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Self-Injurious Behavior Deliberate Self-Harm

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 12-16 years old * Female * Has had first menstruation * Willingness to have de-identified data shared with RDoC database Inclusion Criteria - Adolescents with Non-Suicidal Self-Injury: * Any history of self harm Inclusion Criteria - Healthy Controls: * No history of self harm Exclusion Criteria: * Male * Pregnancy * MRI Incompatibility * IQ of less than 80 * Major Medical Illness * Diagnosis of any of the following: Primary Psychotic Disorder, Bipolar Spectrum Disorder, Autism Spectrum Disorder, Current or Past Substance Use Disorder

Locations (3)

Ambulatory Research Center (ARC)

Minneapolis, Minnesota, United States

Center for Magnetic Resonance Research

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Change in Self-Injurious Thoughts and Behaviors Interview (SITBI)

This scale will be used to assess NSSI frequency in the past month, past year, and lifetime; average age of onset; severity of injuries (number of injuries per episode, severity of tissue damage -- worst point and average), function (automatic versus social, negative versus positive) and other information.

Time frame: Baseline; 12 months; 24 months

Secondary Outcomes

Change in Saliva Cortisol Levels

As a measure of stress response, cortisol levels will be measured after administration of the Trier Social Stress Test. This test is designed to measure HPA axis functioning in the context of an interpersonal threat. Intra- and inter-assay coefficients of variability will be calculated. Summary indexes including slope and area under the curve estimates of cortisol in response to threat and resting conditions will be used in subsequent analyses.

Time frame: Baseline; 12 months; 24 months

Change in Beck Scale for Suicidal Ideation (BSSI)

A 19-item interview, assesses current suicidal ideation, with ratings for active suicidal desire, specific suicide plans, and passive suicidal desire. If the adolescent is assessed to be at risk, a member of the research team will work with the family and the adolescent to develop a safety plan.

Time frame: Baseline; 12 months; 24 months

Change in Inventory of Depression and Anxiety Symptoms (IDAS)

The IDAS is a 54-item assessment that provides a score for 11 domains; we will focus on general depression, suicidality, traumatic intrusion, panic, and social anxiety.

Time frame: Baseline; 12 months; 24 months

Change in Rejection Sensitivity Questionnaire

This assessment measures predicted interpersonal sensitivity and difficulties.

Data from ClinicalTrials.gov

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