Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits

NCT04159168 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-06-15

No results posted yet for this 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 apply this targeted intervention to the wider range of problems associated with CU traits.

Conditions

  • Affective Symptoms
  • Empathy

Interventions

BEHAVIORAL

Facial Affect Sensitivity Training (FAST)

The FAST intervention program represents a novel computerized intervention for high-risk youth that strategically targets implicated facial affect sensitivity deficits directly via a computerized real-time automated feedback and incentive system to remediate callous-unemotional tendencies associated with behavioral dysfunction.

BEHAVIORAL

Implicit Gaze Training task (Active control condition)

This computerized task was developed to target implicit training of eye gaze but not facial emotion recognition per se via real-time feedback and incentives. On each trial, a fixation cross is followed by an emotional face with eyes directed either left, straight ahead, or right (balanced across expressions), followed by a response key. The child's task is to say which direction the eyes are looking (e.g., "1" or "left"). Stimuli are black and white standardized photographs of men and women models from the Ekman Pictures of Facial Affect each displaying the 3 gaze directions for 6 emotion expressions.

Sponsors & Collaborators

  • University of Alabama, Tuscaloosa

    lead OTHER

Principal Investigators

  • Bradley A White, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159168 on ClinicalTrials.gov