Examining Mechanisms of Change in Adolescent Self-Inflicted Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Barriers to skill use as self-reported on ecological momentary assessment
研究概览
简要总结
The goal of this clinical trial is to compare two core intervention skills among adolescents with a history of engaging in at least 3 lifetime incidents of self-inflicted injury (SII), at least one of which was a suicide attempt of at least moderate lethality and moderate intent to die. The main questions it aims to answer are:
Whether and when youth use skills in daily life, how quickly skill use declines after teaching, and whether exposure to life stress influences skill learning and retention.
The Investigators also want to know whether brain-related, family-related, and physiology-related factors influence skills practice and any associated changes in self-harm/suicide risk and emotion dysregulation.
Participants will complete surveys 5 times a day on their phones at baseline, and following each skill learning session. All participants will learn and practice the two skills with a parent while discussing topics they often argue about. During these discussions, participants will be hooked up to psychophysiological equipment to measure their cardiovascular functioning and their palm sweat. Participants' discussions will be coded for skill use and also for indices of family functioning. Approximately half of the participants will undergo two sets of fMRI scans to assess potential neural underpinnings of skill use.
详细描述
Suicide marks an extreme along a continuum of self-inflicted injury (SII) and is a leading cause of death among adolescents. Although psychologists have evidence-supported interventions for youth SII, the biosocial mechanisms supporting change are underexplored. Lack of innovation in this area has led to statis, rather than decline, in population-level suicide rates. The field also lacks vital data on: if/when adolescents apply therapeutic skills in daily life, the neural and physiological factors influencing skill uptake, and whether such skills are effective in reducing SII and related risk and vulnerability factors.
When identifying key intervention targets, theoretical and empirical work implicate emotion dysregulation and interpersonal stressors in SII etiology and maintenance. Adaptive emotion regulation strategies and strong social ties each reduce the likelihood of suicidal ideation and SII among otherwise vulnerable individuals, and improvements in emotion regulation are associated with SII cessation. Yet, the specific skills and mechanisms promoting self-regulatory improvements are not well understood.
This study is designed to rigorously examine two competing SII intervention mechanisms. The research plan and aims are devoted to identifying youth who may benefit from a brief skill-building intervention and biosocial mechanisms supporting skill acquisition. The investigator use a within-subjects design to directly compare the effects of teaching an intra- vs. interpersonal skill from Dialectical Behavior Therapy (DBT; a widely-used intervention for SII). Adolescents with a history of repeated SII (n = 100) will participate in 4 laboratory visits with a primary caregiver. At Visit 1, participants will complete interviews and questionnaires assessing psychiatric diagnoses, SII, and life stress, and 50 will complete two functional MRI paradigms to tap neural processes underlying perspective taking and empathy, and approach/avoidance. Adolescents will then complete a 2-week EMA protocol (EMA1, Training Aim 2) to measure daily affect, perceived stressors, SII, and suicidal thoughts, pre-intervention. At Visit 2, dyads will be randomly assigned to learn and practice GIVE (interpersonal skills training) or opposite-to-emotion action (OA; intrapersonal skill). The investigator will assess behavioral, affective, and physiological regulatory processes (respiratory sinus arrythmia [RSA]) during two conflict discussions: (1) pre- skills training, and (2) post-training, while dyads use their assigned skill. This laboratory assessment will be followed by a second EMA period (EMA2) to assess skill use and EMA1 variables. Post EMA2, dyads will return for Visit 3 to repeat fMRI assessment before undergoing training in the alternate skill ⎯ followed by another 2-week EMA protocol (EMA3). Finally, participants will complete a remote follow-up visit 6 months post-EMA3, where the investigator will reassess SII, symptom severity, and life stressors as well as barriers to skill use. This study will assess and integrate multimodal responses to core intervention mechanisms in a high-risk sample.
Aim 1: Examine within-person mechanistic (brain, RSA) changes as a function of skills training in the laboratory (Training Aim 1).
H1a: Participants will show less RSA withdrawal during skill-practice relative to a pre-training conflict task. H1b: Such intervention changes will translate to increased left ventro-lateral prefrontal cortex engagement during an fMRI paradigm tapping OA; and increased medial pre-frontal cortex engagement during a task tapping perspective taking and empathy (corresponding to GIVE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Research assistants performing behavioral coding will be masked to participant condition.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3+ incidents of self-inflicted injury (SII). At least one SII episode must score a minimum of "3" on lethality (moderate; e.g., overdose on 11-50 pills; deep cuts anywhere but neck) and "4" on intent (somewhat serious [about dying]) - even if aborted or interrupted. Adolescents with 3+ SIIs may also enroll if they have been hospitalized for suicide preparatory behavior.
- •English language proficiency
- •Access to a smart phone
- •Parent/caregiver/legal guardian to participate with the adolescent
排除标准
- •Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis.
- •Those taking medications with well-documented effects on psychophysiological responding.
研究组 & 干预措施
Opposite action
Participants will be randomly assigned to this arm either first or second. All participants complete both arms.
干预措施: Opposite to emotion action (Behavioral)
GIVE
Participants will be randomly assigned to this arm either first or second. All participants complete both arms.
干预措施: GIVE (Behavioral)
结局指标
主要结局
Barriers to skill use as self-reported on ecological momentary assessment
时间窗: Across approximately 2 months
Participant reported barriers to skill use will be assessed via ecological momentary assessment items. This information will aid us in better optimizing how these skills are taught.
Rates of skill use in daily life as assessed via ecological momentary assessment mobile surveys
时间窗: Frequency of skills use reported over the course of two 10-day EMA periods immediately post skills training (EMAs are 5 x per day)
The investigators will assess the rate of self-reported skills use across post-skill training EMA periods to understand retention, generalization, and potential decay effects. We will also examine whether rates increase following a brief booster call intended to reiterate the skill to youth participants.
Self-injurious urges, behaviors, and suicidal ideation as reported on ecological momentary assessment items
时间窗: Changes will be assessed from pre-intervention baseline (Visit 1 and a ten day baseline EMA period [EMA1]) across EMA 2 and 3, and 6-month follow-up (post-intervention).
Change in self-reported rates and intensity of self-inflicted injury urges/behavior and suicidal ideation will be assessed from pre- to post-skills training. We will compare data from baseline interviews/surveys/EMA1 to post-skills training time points (EMA2 and EMA 3) and 6-month follow-up (assessed with the L-SASII). Frequency of self-reported skill use in daily life will be used as a key predictor variable.
Emotion regulation/dysregulation changes as assessed on the difficulties in emotion regulation scale- short form (DERS-SF)
时间窗: Patterns and changes in emotion regulation/dysregulation indices will be assessed from Visit 1 through 6-month follow-up (approximately 8 months).
The investigators will be examining change in self-reported emotion regulation/dysregulation from the pre-intervention discussion task to post-skills training via the difficulties in emotion regulation scale short form (DERS-SF). The answers are assessed using a 5-point Likert scale, from 1 (almost never) to 5 (almost always). It is possible to obtain the score of each of 6 subscales, and the total score of the DERS-SF (18-90), with higher values indicating greater difficulties in emotion regulation.
Neural patterns and changes from pre- to post-skills training on fMRI tasks (Opposite action paradigm and EmpaTom-Y)
时间窗: Visit 1 and post-intervention scan at Visit 3 (taken approximately 5-6 weeks apart.
Participants will learn skills in the laboratory environment and implement them in daily life. The investigators will observe change in neural activation in response to skill-targeted probes of empathy and perspective taking and opposite action from pre- to post-training (Visit 1 to Visit 3). Specifically, the investigators expect intervention changes will translate to (1) increased left ventro-lateral prefrontal cortex engagement during an fMRI paradigm tapping opposite action; and (2) increased medial pre-frontal cortex engagement during a task tapping perspective taking and empathy (EmpaTom-Y; corresponding to GIVE).
Impact of life stress (assessed with the Life Events and Difficulties Schedule; LEDS-II) on skill learning and retention as reported on ecological momentary assessment items
时间窗: A baseline life stress assessment will be completed at Visit 1 (Life Events and Difficulties Schedule; LEDS-II). Skill learning and retention will be assessed via ecological momentary assessment items assessing skill use for approximately 6 weeks.
The investigators will assess associations between experiences of life stress at baseline (assessed via the LEDS-II interview) and subsequent rates of skill use in daily life (EMA2 and EMA3).
次要结局
- Impact of skills use on life stress as assessed by the Life Events and Difficulties Schedule (LEDS-II)(Approximately 8 months)
- Changes in family functioning from pre-intervention to post-intervention discussion tasks as assessed via The System for Coding Interactions and Family Functioning (SCIFF)(Across approximately 4-5 weeks)
- Examine changes in emotion regulation/dysregulation from pre- to post-intervention discussion tasks via respiratory sinus arrhythmia (RSA)(Across approximately 1 month)
研究者
Erin Kaufman
Assistant Professor
University of Utah