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临床试验/NCT04159168
NCT04159168已完成不适用

Facial Affect Sensitivity Training for Young Children With CU Traits

University of Alabama, Tuscaloosa2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2021年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
161
试验地点
2
主要终点
Change in Eye Gaze (R61 phase primary milestone measure)

研究概览

简要总结

The goal of this study is to test a novel intervention for children ages 6-11 with elevated callous-unemotional (CU) traits. Conduct problems are among the most prevalent and costly mental health conditions of childhood, and a common antecedent to adult psychiatric disorders. An established risk factor for early, persistent, and severe youth misconduct is the presence of CU traits. CU traits (e.g., lack of empathy or guilt, shallow affect) are analogous to the core affective features of adult psychopathy, interfere with child socialization, and predict poorer outcomes, even with well-established treatments for disruptive behavior disorders. Thus, novel intervention approaches are needed to target CU traits. Youth with elevated CU traits show deficits in facial emotion recognition (FER) for distress-related expressions, particularly fear or sadness. The central hypothesis is that impaired sensitivity for emotional distress cues (fear and/or sadness) is mechanistically linked to CU traits in children, and that, by targeting affect sensitivity directly, intervention can exert downstream effects on CU traits. A gap in the field regards how to remediate these neurocognitive deficits. This project will directly target affect sensitivity in high-CU youth. The investigators propose an experimental therapeutics approach to develop a novel neurocognitive intervention for CU traits, in which a clearly identified target, facial affect sensitivity (FAS), will be engaged and assessed via primary (distress FER accuracy and/or heightened eye gaze) and secondary (electroencephalograph event-related potential) neurocognitive and behavioral processes. If investigators can demonstrate engagement of the target (FAS) in the initial R61 phase, then in the R33 phase, this finding will be replicated with a new, larger sample, and feasibility and preliminary efficacy of FAST on CU traits will be examined. The long-term goal is to examine FAST impact on behavioral outcomes and to potentially apply this targeted intervention to the wider range of problems associated with CU traits.

详细描述

This project will directly target affect sensitivity in high-CU youth. Per the National Institute of Mental Health (NIMH) Strategic Plan (Objective 3.1), the investigators propose an experimental therapeutics approach to develop a novel neurocognitive intervention for CU traits, in which a clearly identified target, facial affect sensitivity (FAS), will be engaged and assessed via primary [distress facial emotion recognition (FER) accuracy, heightened eye gaze] and secondary (EEG event-related potential) neurocognitive and behavioral processes. The long-term goal is to apply this targeted intervention to the wider range of problems associated with CU traits. The R61 phase Specific Aims are as follows: Investigators will first demonstrate, in a preliminary randomized controlled trial (RCT; N=84 children), that a new neurocognitive intervention (Facial Affect Sensitivity Training: FAST) can improve FAS [target engagement] in children with elevated CU traits. FAS will be measured primarily by FER accuracy for distress expressions and/or heightened attention to the eye region (eye gaze), and secondarily by neural activity [specifically, N170 and P200 event-related potential (ERP) components]. Objective 1: Establish that distress FER accuracy and/or eye gaze can be altered in a reliable manner among young children with elevated CU traits. Objective 2: Determine whether FAST improves secondary neural indices of FAS (brain activity during processing of emotional faces). Objective 3: Refine FAST for subsequent evaluation by determining optimal dose parameters with regard to number of sessions for FER and/or eye gaze improvement via a nonlinear mixed model for small samples (e.g., timing of local bump or decay, amount of change, when maximal change occurs), and participant satisfaction with session frequency, length, and number. Objective 4: Deliver a computerized training program (FAST) capable of providing real-time automated feedback and reinforcement of accurate FER performance. Milestones (Go/No-Go Criteria): (1) FAST will engage the target (FAS), indexed by enhancing distress FER accuracy and/or eye gaze in high-CU youth. The investigators will examine individual growth rates and test slope differences between conditions (FAST v control). Target engagement will be defined as medium effect size (defined as Cohen's d value = .50) in the comparison of FAST vs. no-treatment control on the primary target (distress FER and/or eye gaze). The R33 phase Specific Aims are as follows: The investigators aim to replicate target engagement with a new, large high-CU sample and evaluate feasibility and preliminary efficacy of FAST, in the context of an RCT (N = 84) in which FAST is compared to an active control condition (ACC; implicit eye gaze training). In addition, this phase will validate the functional role of FAS by examining downstream change in CU as a result of FAST. FAST will produce reliable increases in FER accuracy for distress cues in others. Furthermore, FAST completers will show greater improvement in CU/empathic behaviors than ACC completers. Objective 5: Replicate target engagement of FAS. Objective 6: Determine if improved FAS leads to reduction in CU traits. The investigators will also consider in a preliminary fashion whether CU trait reductions are clinically significant (more than .5 pre-test standard deviation on 2 target CU indices or more than 1.0 standard deviation on one CU measure). If the FAST intervention improves FER and reduces CU traits, such training in early childhood could help interrupt the developmental cascade toward antisocial outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

An assessment-naïve independent evaluator not involved in intervention implementation will function will provide Clinical Global Impression (CGI) evaluations.

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A standard score less than or equal to 9 on the NEPSY (A Developmental NEuroPSYchological Assessment) Affect Recognition (AR) test, or less than or equal to 70% accuracy for distress-related emotions on a Dynamic FER measure.
  • Composite intelligence quotient (IQ) score of at least 72 on the Wechsler Abbreviated Scale of Intelligence, Second Edition.
  • Any psychotropic medications must be on stable dosing schedule for 2 weeks prior to entry.
  • Presence of elevated CU traits, defined as a total score of at least 2 on the 4 CU items of the Antisocial Process Screening Device (APSD), Parent Version, with caregiver-endorsed distress or impairment required for scores of exactly 2.

排除标准

  • Bipolar disorder. Current risk for suicide or harm to others. Autism spectrum disorder (ASD) diagnosis. Currently participating in therapy for CU traits or facial emotion recognition deficits.

研究组 & 干预措施

Arm 1: R61 FAST

Experimental

Individuals in this Arm will receive the FAST intervention, as described in the Intervention section of the Clinical Trials form below, with a focus on demonstrating target (facial affect sensitivity) engagement.

干预措施: Facial Affect Sensitivity Training (FAST) (Behavioral)

Arm 2: R61 No-Treatment Control

No Intervention

Individuals in this Arm will not receive any intervention.

Arm 3: R33 FAST

Experimental

Individuals randomized this Arm of the R33 phase will receive the FAST intervention, with the aim of replicating FAST target engagement (as demonstrated in the R61 phase) with a new high-CU sample, and to evaluate the FAST intervention in comparison to an active control condition (Arm 4, implicit eye gaze training).

干预措施: Facial Affect Sensitivity Training (FAST) (Behavioral)

Arm 4: R33 Active Control

Active Comparator

Individuals in this Arm will receive the active control component, which is an implicit gaze training intervention.

干预措施: Implicit Gaze Training task (Active control condition) (Behavioral)

结局指标

主要结局

Change in Eye Gaze (R61 phase primary milestone measure)

时间窗: Eye gaze will be assessed in each phase (R61 & R33) of the study at pre-treatment (session 1), post-treatment (end of 5 weeks), and 3-month follow-up as well as approximately every other week during the 5-week intervention.

Heightened attention to the eye region (eye gaze) will be indexed by primacy, dwell time, and frequency of fixation on the eye region of emotional faces, measured via eye tracking while participants complete the FER task.

Change in Facial Emotion Recognition (R61 phase primary milestone measure)

时间窗: FER will be assessed in each phase (R61 & R33) of the study at pre-treatment (session 1), post-treatment (end of 5 weeks), and 3-month follow-up as well as approximately every other week during the 5-week intervention.

Recognition of facial emotional expressions will be indexed based on accuracy of matching emotion expressions on the FACES and Dynamic FER tasks.

Change in Callous-Unemotional Traits (R33 phase primary outcome)

时间窗: CU Traits will be assessed during the the R33 phase at pre-treatment, post-treatment (end of 5 weeks), and 3-month follow-up as well as approximately every other week during the 5-week intervention.

CU traits will be assessed using the Inventory of Callous-Unemotional Traits. There are subscales for callousness, uncaring, and unemotional tendencies. Higher scores reflect higher reported CU traits.

次要结局

  • Change in Clinical Global Impression (CGI) score(CGI will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in the R33 phase.)
  • Change in Griffith Empathy Measure Score(GEM will be assessed during the R33 phase at pre-treatment, post-treatment (end of 5 weeks), and 3-month follow up, and approximately every other week during the 5-week intervention.)
  • Change in "I Love You" Task(The "I Love You" task will be administered during the R33 phase at pre-treatment, post-treatment (end of 5 weeks), and 3-month follow up)
  • Change in Event Related Potential (ERP) signal(ERPs will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in both R61 and R33 phases.)

研究者

发起方
University of Alabama, Tuscaloosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bradley A. White

Associate Professor

University of Alabama, Tuscaloosa

研究点 (2)

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