Clinical trial NCT02947308: A Study Examining Adolescents With Non-Suicidal Self-Injury
Official title: A Longitudinal Study Examining Three RDoC Constructs in Adolescents With Non-Suicidal Self-Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Self-Injurious Behavior
Deliberate Self-Harm
Keywords: Anxiety
Depression
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-10-27
Enrollment: 168
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with a history of NSSI will be recruited from community outlets such as flyers, as well as through social media (e.g., Facebook and Pandora). Additionally, these adolescents will be recruited through local clinicians who treat adolescent mood disorders. Healthy controls will be recruited through community outlets and social media.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Self-Injurious Thoughts and Behaviors Interview (SITBI)
timeFrame: Baseline; 12 months; 24 months
Secondary outcomes:
measure: Change in Saliva Cortisol Levels
timeFrame: Baseline; 12 months; 24 months
measure: Change in Beck Scale for Suicidal Ideation (BSSI)
timeFrame: Baseline; 12 months; 24 months
measure: Change in Inventory of Depression and Anxiety Symptoms (IDAS)
timeFrame: Baseline; 12 months; 24 months
measure: Change in Rejection Sensitivity Questionnaire
timeFrame: Baseline; 12 months; 24 months
measure: Change in Personality Assessment Inventory, Adolescent Form (PAI-A)
timeFrame: Baseline; 12 months; 24 months
measure: Change in the Dot-Probe Task
timeFrame: Baseline; 12 months; 24 months
measure: Change in Self Perception Profile for Adolescents
timeFrame: Baseline; 12 months; 24 months
measure: Change in Barratt Impulsiveness Scale (BIS)
timeFrame: Baseline; 12 months; 24 months
measure: Change in UPPS-P
timeFrame: Baseline; 12 months; 24 months
measure: Change in the Emotional Go/NoGo task
timeFrame: Baseline; 12 months; 24 months
measure: Change in MRI Data
timeFrame: Baseline; 12 months; 24 months
measure: Change in Timeline Followback Method (TLFB) for NSSI
timeFrame: Baseline; 12 months; 24 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Ambulatory Research Center (ARC)
state: Minnesota
city: Minneapolis
country: United States
facility: Center for Magnetic Resonance Research
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kathryn Cullen
role: PRINCIPAL_INVESTIGATOR
References: