A Study Examining Adolescents With Non-Suicidal Self-Injury

NCT ID: NCT02947308

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2025-07-18

Brief Summary

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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

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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.

Conditions

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Self-Injurious Behavior Deliberate Self-Harm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adolescents with NSSI

12-16 year old females who have a history of non-suicidal self-injury are included in this cohort. No interventions will be administered.

No interventions assigned to this group

Healthy Controls

12-16 year old females with no history of non-suicidal self-injury are included in this cohort.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 12-16 years old
* Female
* Has had first menstruation
* Willingness to have de-identified data shared with RDoC database


* Any history of self harm


* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Cullen

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Ambulatory Research Center (ARC)

Minneapolis, Minnesota, United States

Site Status

Center for Magnetic Resonance Research

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1R01MH107394-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSYCH-2016-24795

Identifier Type: -

Identifier Source: org_study_id

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