Empathy Clinical Trial
Official title:
Facial Affect Sensitivity Training for Young Children With CU 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 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.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Youth Development and Intervention (CYDI) | Tuscaloosa | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama, Tuscaloosa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Change in Griffith Empathy Measure Score | Griffith Empathy Measure (GEM ), is a 23-item parent-report measure of affective (shared emotional state) and cognitive (perspective taking) empathy. The maximum score is 92. Higher scores reflect higher reported empathy. | 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. | |
Secondary | Change in "I Love You" Task | The I Love You Task is a dyadic interactional task for young children utilizing a brief emotionally intense parent-child encounter for which reciprocated eye gaze and affection is fundamental. | 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 | |
Secondary | Change in Clinical Global Impression (CGI) score | The Clinical Global Impression (CGI) score will be determined as a common clinical trial index, with CGI-I improvement scores of 1 or 2 (very much/much improved, based on independent rater score) as being responsive to the intervention. | CGI will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in the R33 phase. | |
Secondary | Change in Event Related Potential (ERP) signal | Event related potentials that are previously identified neural correlates of early perceptual and emotional processing of facial expressions, specifically, N170 and P200 ERP components, assessed via electroencephalography. | ERPs will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in both R61 and R33 phases. |
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