A Study Examining Adolescents With Non-Suicidal Self-Injury

NCT02947308 | Completed Results

• 2 other identifiers: PSYCH-2016-247951R01MH107394-01A1
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 3

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 Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a cognitive battery.

Conditions

Self-Injurious Behavior; Deliberate Self-Harm

Keywords

Anxiety; Depression

Outcome Measures

Primary Outcomes (9)

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Lifetime Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on lifetime frequency -- the total number of episodes throughout the youth's life. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Baseline

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Past Year Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on past-year frequency, defined as the number of episodes occurring within the year leading up to the interview date. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Baseline

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Past Month Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on past-month frequency, defined as the number of episodes occurring within the month leading up to the interview date. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Baseline

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Lifetime Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on lifetime frequency -- the total number of episodes throughout the youth's life. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Month 12

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Past Year Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on past-year frequency, defined as the number of episodes occurring within the year leading up to the interview date. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Month 12

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Past Month Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on past-month frequency, defined as the number of episodes occurring within the month leading up to the interview date. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Month 12

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Lifetime Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on lifetime frequency -- the total number of episodes throughout the youth's life. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Month 24

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Past Year Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on past-year frequency, defined as the number of episodes occurring within the year leading up to the interview date. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Month 24

• Self-Injurious Thoughts and Behaviors Interview (SITBI) - Past Month Episodes

  The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a semi-structured clinical interview providing standardized, comprehensive measurement of self-injury. The interview is organized into modules, each starting with a screening question regarding lifetime presence. If a behavior is denied, the module is skipped; if endorsed, the SITBI assesses frequency (lifetime, past year, month, and week), onset, severity (injuries per episode and tissue damage), function, duration, and methods. Higher scores indicate greater severity of Non-Suicidal Self-Injury (NSSI). This specific outcome focuses solely on past-month frequency, defined as the number of episodes occurring within the month leading up to the interview date. Because the SITBI is an interview-based assessment rather than a rating scale, scores reflect the raw number of episodes; thus, while the minimum value is 0, the maximum value is not predetermined.

  Month 24

Secondary Outcomes (51)

• Salivary Cortisol Response to Stress

  Baseline

• Salivary Cortisol Response to Stress

  Month 12

• Salivary Cortisol Response to Stress

  Month 24

• Beck Scale for Suicidal Ideation (BSSI)

  Baseline

• Beck Scale for Suicidal Ideation (BSSI)

  Month 12

Study Arms (2)

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.

Healthy Controls

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

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Ambulatory Research Center (ARC)

Minneapolis, Minnesota, 55454, United States

Location

Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Nair et al. 2023, Clinical Trajectories in Adolescents with and without a History of Non-Suicidal Self-Injury: The BRIDGES Longitudinal Study
• Basgoze et al. 2021, Multimodal assessment of sustained threat in adolescents with nonsuicidal self-injury
• Basgoze et al. 2023, A Multilevel Examination of Cognitive Control in Adolescents With Nonsuicidal Self-injury
• Thai et al. 2024, A multi-modal assessment of self-knowledge in adolescents with non-suicidal self-injury: a research domains criteria (RDoC) study

Biospecimen

Retention: SAMPLES WITHOUT DNA

De-identified saliva samples will be retained until the completion of the study. At the time of the completion, samples will be destroyed.

MeSH Terms

Conditions

Self-Injurious Behavior; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

Dropout was likely influenced by the protocol's multiple visits which each included measures that were time consuming and, at times, emotionally taxing. The COVID-19 pandemic interrupted participant recruitment and data collection. The study only included adolescents who were assigned female at birth. The final sample had relatively low rates of racial and ethnic minorities.

Results Point of Contact

• Title: Kathryn Cullen
• Organization: University of Minnesota

rega0026@umn.edu

(612) 625-3403

Study Officials

• Kathryn Cullen

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 27, 2016
• Study Start: August 1, 2016
• Primary Completion: July 18, 2022
• Study Completion: July 11, 2023
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-03

Locations

US (3)