Self-Injurious Behavior Clinical Trial
— RDoCOfficial title:
A Longitudinal Study Examining Three RDoC Constructs in Adolescents With Non-Suicidal Self-Injury
Verified date | March 2024 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 168 |
Est. completion date | July 18, 2025 |
Est. primary completion date | July 18, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 12 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ambulatory Research Center (ARC) | Minneapolis | Minnesota |
United States | Center for Magnetic Resonance Research | Minneapolis | Minnesota |
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline; 12 months; 24 months | |
Secondary | 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. | Baseline; 12 months; 24 months | |
Secondary | 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. | Baseline; 12 months; 24 months | |
Secondary | 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. | Baseline; 12 months; 24 months | |
Secondary | Change in Rejection Sensitivity Questionnaire | This assessment measures predicted interpersonal sensitivity and difficulties. | Baseline; 12 months; 24 months | |
Secondary | Change in Personality Assessment Inventory, Adolescent Form (PAI-A) | A self-report personality indicator for adolescent populations based on 22 scales of psychological well-being. | Baseline; 12 months; 24 months | |
Secondary | Change in the Dot-Probe Task | A computerized assessment designed to assess attentional bias to threat, as well as provide a behavioral measure of "vigilance" to threat (reaction times for a spatial task influenced by the presence of emotion faces). | Baseline; 12 months; 24 months | |
Secondary | Change in Self Perception Profile for Adolescents | An assessment designed to evaluate and measure six self-concept domains: Scholastic Competence, Athletic Competence, Social Competence, Physical Appearance, and Behavioral Conduct and Global Self-Worth. | Baseline; 12 months; 24 months | |
Secondary | Change in Barratt Impulsiveness Scale (BIS) | This scale utilizes self-report measures of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). | Baseline; 12 months; 24 months | |
Secondary | Change in UPPS-P | This measure will be used to determine "Negative Urgency", or the tendency of an individual to act impulsively while they are in a state of negative affect. | Baseline; 12 months; 24 months | |
Secondary | Change in the Emotional Go/NoGo task | This measure will be used to assess response inhibition in the context of negative emotion contexts. | Baseline; 12 months; 24 months | |
Secondary | Change in MRI Data | Cortical thickness, brain activation, and functional connectivity several key networks (fronto-striatal, fronto-limbic, and medial cortical network) will be measured using structural and functional MRI. | Baseline; 12 months; 24 months | |
Secondary | Change in Timeline Followback Method (TLFB) for NSSI | A calendar format measure to retrospectively collect behavioral data that was adapted from an instrument for alcohol use will be used measure NSSI episodes that had occurred in the year between each visit. | Baseline; 12 months; 24 months |
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