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

Conditions

• Affective Symptoms
• Empathy

Eligibility Criteria

Sex

ALL

Age

6 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Facial Affect Sensitivity Training (FAST) — BEHAVIORAL
  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.
• Implicit Gaze Training task (Active control condition) — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Feb 15, 2021

Status verified

Jun 2025

Primary completion

May 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

168 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: R61 FAST
  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.
• No Intervention: Arm 2: R61 No-Treatment Control
  Individuals in this Arm will not receive any intervention.
• Experimental: Arm 3: R33 FAST
  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).
• Active Comparator: Arm 4: R33 Active Control
  Individuals in this Arm will receive the active control component, which is an implicit gaze training intervention.

Primary Outcome Measure

Change in Facial Emotion Recognition (R61 phase primary milestone measure) [ Time Frame: 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. ]

Central Contacts

• Bradley A White, PhD
  (205) 348-0251
  [email protected]
• Susan W White, PhD
  (205) 348-1967
  [email protected]

Locations (1)

Find similar trials in Tuscaloosa, AL

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