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临床试验/NCT02947308
NCT02947308
已完成
不适用

A Longitudinal Study Examining Three RDoC Constructs in Adolescents With Non-Suicidal Self-Injury

University of Minnesota3 个研究点 分布在 1 个国家目标入组 168 人2016年8月1日

概览

阶段
不适用
干预措施
Adolescents with NSSI
疾病 / 适应症
Self-Injurious Behavior
发起方
University of Minnesota
入组人数
168
试验地点
3
主要终点
Self-Injurious Thoughts and Behaviors Interview (SITBI) - Lifetime Episodes
状态
已完成
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2016年8月1日
结束日期
2023年7月11日
最后更新
上个月
研究类型
Observational
性别
Female

研究者

责任方
Sponsor

入排标准

入选标准

  • 12-16 years old
  • 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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

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

时间窗: Baseline

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.

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

时间窗: Baseline

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.

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

时间窗: Baseline

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.

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

时间窗: Month 12

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.

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

时间窗: Month 12

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.

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

时间窗: Month 12

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.

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

时间窗: Month 24

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.

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

时间窗: Month 24

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.

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

时间窗: Month 24

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.

次要结局

  • 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)
  • Beck Scale for Suicidal Ideation (BSSI)(Month 24)
  • Beck Depression Inventory(Baseline)
  • Beck Depression Inventory(Month 12)
  • Beck Depression Inventory(Month 24)
  • Personality Assessment Inventory, Adolescent Form (PAI-A)(Baseline)
  • Personality Assessment Inventory, Adolescent Form (PAI-A)(Month 12)
  • Personality Assessment Inventory, Adolescent Form (PAI-A)(Month 24)
  • SPPA, Global Self-worth(Baseline)
  • SPPA, Global Self-worth(Month 12)
  • SPPA, Global Self-worth(Month 24)
  • Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P)(Baseline)
  • Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P)(Month 12)
  • Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P)(Month 24)
  • D-prime (d') Values Representing Response-inhibition Performance on the Emotional Go/NoGo Task(Baseline)
  • D-prime (d') Values Representing Response-inhibition Performance on the Emotional Go/NoGo Task.(Month 12)
  • D-prime (d') Values Representing Response-inhibition Performance on the Emotional Go/NoGo Task.(Month 24)
  • Self-Network Cortical Thickness (Structural MRI)(Baseline)
  • Self-Network Cortical Thickness (Structural MRI)(Month 12)
  • Self-Network Cortical Thickness (Structural MRI)(Month 24)
  • Cognitive Control Network Cortical Thickness and Subcortical Volume (Structural MRI)(Baseline)
  • Cognitive Control Network Cortical Thickness and Subcortical Volume (Structural MRI)(Month 12)
  • Cognitive Control Network Cortical Thickness and Subcortical Volume (Structural MRI)(Month 24)
  • Amygdala Volume (Structural MRI)(Baseline)
  • Amygdala Volume (Structural MRI)(Month 12)
  • Amygdala Volume (Structural MRI)(Month 24)
  • Bilateral Self-Network Task fMRI Activation During Negative vs Positive Evaluation Conditions of the Self vs Change Task(Baseline)
  • Bilateral Self-Network Task fMRI Activation During Negative vs Positive Evaluation Conditions of the Self vs Change Task(Month 12)
  • Bilateral Self-Network Task fMRI Activation During Negative vs Positive Evaluation Conditions of the Self vs Change Task(Month 24)
  • Bilateral Cognitive Control Network Task fMRI Activation During Inhibition in Negative Contexts Versus Scrambled Contexts in the Go/No-Go Task(Baseline)
  • Bilateral Cognitive Control Network Task fMRI Activation During Inhibition in Negative Contexts Versus Scrambled Contexts in the Go/No-Go Task(Month 12)
  • Bilateral Cognitive Control Network Task fMRI Activation During Inhibition in Negative Contexts Versus Scrambled Contexts in the Go/No-Go Task(Month 24)
  • Bilateral Amygdala Activation to the Negative Face vs Shape (Threat) Condition of the Emotional Face Matching Task(Baseline)
  • Bilateral Amygdala Activation to the Negative Face vs Shape (Threat) Condition of the Emotional Face Matching Task(Month 12)
  • Bilateral Amygdala Activation to the Negative Face vs Shape (Threat) Condition of the Emotional Face Matching Task(Month 24)
  • Resting-state Functional Connectivity Within Anterior and Posterior Nodes of the Self Network(Baseline)
  • Resting-state Functional Connectivity Within Anterior and Posterior Nodes of the Self Network(Month 12)
  • Resting-state Functional Connectivity Within Anterior and Posterior Nodes of the Self Network(Month 24)
  • Resting-state Functional Connectivity Within the Cognitive Control Network(Baseline)
  • Resting-state Functional Connectivity Within the Cognitive Control Network(Month 12)
  • Resting-state Functional Connectivity Within the Cognitive Control Network(Month 24)
  • Timeline Followback(Baseline)
  • Timeline Followback(Month 12)
  • Timeline Followback(Month 24)

研究点 (3)

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