Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits
1 other identifier
interventional
168
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
June 15, 2025
June 1, 2025
5.3 years
October 28, 2019
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Facial Emotion Recognition (R61 phase primary milestone measure)
Recognition of facial emotional expressions will be indexed based on accuracy of matching emotion expressions on the FACES and Dynamic FER tasks.
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.
Change in Eye Gaze (R61 phase primary milestone measure)
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.
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.
Change in Callous-Unemotional Traits (R33 phase primary outcome)
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.
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.
Secondary Outcomes (4)
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 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 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.
Study Arms (4)
Arm 1: R61 FAST
EXPERIMENTALIndividuals 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.
Arm 2: R61 No-Treatment Control
NO INTERVENTIONIndividuals in this Arm will not receive any intervention.
Arm 3: R33 FAST
EXPERIMENTALIndividuals 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).
Arm 4: R33 Active Control
ACTIVE COMPARATORIndividuals in this Arm will receive the active control component, which is an implicit gaze training intervention.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- A standard score less than or equal to 8 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 80 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 in prior studies as score of "2" on at least 2 of the 4 CU items on the Antisocial Process Screening Device (APSD).
You may not qualify if:
- Bipolar disorder.
- Current risk for suicide or harm to others.
- Autism spectrum disorder (ASD).
- Currently participating in therapy for CU traits or facial emotion recognition deficits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Youth Development and Intervention (CYDI)
Tuscaloosa, Alabama, 35487, United States
Related Publications (1)
White BA, Dede B, Heilman M, Revilla R, Lochman J, Hudac CM, Bui C, White SW. Facial Affect Sensitivity Training for Young Children with Emerging CU Traits: An Experimental Therapeutics Approach. J Clin Child Adolesc Psychol. 2022 May-Jun;51(3):264-276. doi: 10.1080/15374416.2022.2056895. Epub 2022 Apr 29.
PMID: 35486474BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley A White, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- An assessment-naïve independent evaluator not involved in intervention implementation will function will provide Clinical Global Impression (CGI) evaluations.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 28, 2019
First Posted
November 12, 2019
Study Start
February 15, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
June 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The investigators will make de-identified data generated through this project available for research purposes to qualified individuals within the scientific community no later than the time of publication of the main findings from the final data set. Additionally, data will be shared with the NIMH Data Archive (NDA) that includes the National Database for Clinical Trials related to Mental Illness (NDCT). The investigators will abide by the data submission schedule given us in the NDA. Data will be provided within the recommended data structures of the NDA. In addition, the study will be registered with ClinicalTrials.gov and will share results with ClinicalTrials.gov within one year of the completion of data collection of the primary outcome measures. Sharing of the data generated by this project will be in accordance with all applicable regulations and guidelines of NIH.
- Access Criteria
- Requests for individual participant data (IPD) or other study information will be reviewed by the PI (B. White). He will make determination as to legitimacy of the request and qualifications of the requestor.
Per the Dissemination Plan, the investigators will follow the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information and University of Alabama's Office for Sponsored Research policy of compliance monitoring (Sponsored Projects Agreements for Human Subjects Research and Human Research Protections).