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NCT04159168 · ClinicalTrials.gov registry record · NA
Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits
A NA study of Empathy and Affective Symptoms, sponsored by University of Alabama, Tuscaloo.
- Recruiting
- Registry status
- NA
- Development phase
- 168
- Enrollment target
- 1
- Study location
NCT04159168: Recruiting NA study of Empathy and Affective Symptoms, sponsored by University of Alabama, Tuscaloo.
NCT04159168 is a NA study of Empathy and Affective Symptoms that is actively recruiting participants, run by University of Alabama, Tuscaloo. The registered enrollment target is 168 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04159168, a NA study of Empathy and Affective Symptoms, is actively recruiting participants, sponsored by University of Alabama, Tuscaloo.
- RECRUITING
- Registry status
- NA
- Development phase
- 168 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Recognition of facial emotional expressions will be indexed based on accuracy of matching emotion expressions on the FACES and Dynamic FER tasks.
Conditions Studied
Interventions
- BEHAVIORAL Facial Affect Sensitivity Training (FAST)
- BEHAVIORAL Implicit Gaze Training task (Active control condition)
Study Locations (1)
Alabama
- Center for Youth Development and Intervention (CYDI) - Tuscaloosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT04159168 shows while recruiting
NCT04159168 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Empathy appearing as the primary indexed condition, and to 2 interventions - of which Facial Affect Sensitivity Training (FAST) is the first listed.
NCT04159168 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04159168 about?
NCT04159168 is a clinical study titled "Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits". 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 fac...
What is the current status of trial NCT04159168?
This trial is currently recruiting. It is a NA study. The enrollment target is 168 participants. The study started on 2021-02-15. Estimated completion is 2026-07-31.
What conditions does trial NCT04159168 study?
This clinical trial studies the following conditions: Empathy, Affective Symptoms.
What interventions are being tested in trial NCT04159168?
The interventions under investigation include: Facial Affect Sensitivity Training (FAST) (BEHAVIORAL), Implicit Gaze Training task (Active control condition) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04159168?
This trial is sponsored by University of Alabama, Tuscaloo, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04159168 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04159168's enrollment target sits among peer trials
168 619th of 2000 higher than 1,379 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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