Clinical trial NCT04159168: Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits
Official title: Facial Affect Sensitivity Training for Young Children With CU Traits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Affective Symptoms
Empathy
Keywords: Attention [F02.830.104.214]
Temperament [F01.752.898]
Problem Behavior [F01.145.179.750]
Social Behavior [F01.145.813]
Electroencephalography [E01.370.405.245]
Neuropsychological Tests [F04.711.513]
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 168
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study utilizes a randomized controlled trial design to test whether a new neurocognitive intervention (Facial Affect Sensitivity Training: FAST) can improve facial affect sensitivity (FAS) in children with elevated CU traits. In FAST, which uses exogenous incentives to train FAS, a series of emotional facial expressions are presented on a computer monitor. Child participants are instructed to look at the eyes of the emotional expressions they view, and must select from a list of emotions the one that matches the facial expression they saw on each trial, which results in reinforcement of correct responses via auditory reward tone. Correct responses also earn points toward incrementally "priced" small toys given at the end of each session. The objective is to make appropriate eye gaze more automatic during FER (thus improving facial affect sensitivity) by repeatedly pairing correct responses with a reward.
Primary purpose: TREATMENT

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.

Detailed description: This project will directly target affect sensitivity in high-CU youth. Per the National Institute of Mental Health (NIMH) Strategic Plan (Objective 3.1), 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 \[distress facial emotion recognition (FER) accuracy, heightened eye gaze\] and secondary (EEG event-related potential) neurocognitive and behavioral processes. The long-term goal is to apply this targeted intervention to the wider range of problems associated with CU traits. The R61 phase Specific Aims are as follows: Investigators will first demonstrate, in a preliminary randomized controlled trial (RCT; N=84 children), that a new neurocognitive intervention (Facial Affect Sensitivity Training: FAST) can improve FAS \[target engagement\] in children with elevated CU traits. FAS will be measured primarily by FER accuracy for distress expressions and/or heightened attention to the eye region (eye gaze), and secondarily by neural activity \[specifically, N170 and P200 event-related potential (ERP) components\]. Objective 1: Establish that distress FER accuracy and/or eye gaze can be altered in a reliable manner among young children with elevated CU traits. Objective 2: Determine whether FAST improves secondary neural indices of FAS (brain activity during processing of emotional faces). Objective 3: Refine FAST for subsequent evaluation by determining optimal dose parameters with regard to number of sessions for FER and/or eye gaze improvement via a nonlinear mixed model for small samples (e.g., timing of local bump or decay, amount of change, when maximal change occurs), and participant satisfaction with session frequency, length, and number. Objective 4: Deliver a computerized training program (FAST) capable of providing real-time automated feedback and reinforcement of accurate FER performance. Milestones (Go/No-Go Criteria): (1) FAST will engage the target (FAS), indexed by enhancing distress FER accuracy and/or eye gaze in high-CU youth. The investigators will examine individual growth rates and test slope differences between conditions (FAST v control). Target engagement will be defined as medium effect size (defined as Cohen's d value = .50) in the comparison of FAST vs. no-treatment control on the primary target (distress FER and/or eye gaze). The R33 phase Specific Aims are as follows: The investigators aim to replicate target engagement with a new, large high-CU sample and evaluate feasibility and preliminary efficacy of FAST, in the context of an RCT (N = 84) in which FAST is compared to an active control condition (ACC; implicit eye gaze training). In addition, this phase will validate the functional role of FAS by examining downstream change in CU as a result of FAST. FAST will produce reliable increases in FER accuracy for distress cues in others. Furthermore, FAST completers will show greater improvement in CU/empathic behaviors than ACC completers. Objective 5: Replicate target engagement of FAS. Objective 6: Determine if improved FAS leads to reduction in CU traits. The investigators will also consider in a preliminary fashion whether CU trait reductions are clinically significant (more than .5 pre-test standard deviation on 2 target CU indices or more than 1.0 standard deviation on one CU measure). If the FAST intervention improves FER and reduces CU traits, such training in early childhood could help interrupt the developmental cascade toward antisocial outcomes.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Facial Emotion Recognition (R61 phase primary milestone measure)
timeFrame: 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.
measure: Change in Eye Gaze (R61 phase primary milestone measure)
timeFrame: 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.
measure: Change in Callous-Unemotional Traits (R33 phase primary outcome)
timeFrame: 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:
measure: Change in Griffith Empathy Measure Score
timeFrame: 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.
measure: Change in "I Love You" Task
timeFrame: 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
measure: Change in Clinical Global Impression (CGI) score
timeFrame: CGI will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in the R33 phase.
measure: Change in Event Related Potential (ERP) signal
timeFrame: ERPs will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in both R61 and R33 phases.
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Center for Youth Development and Intervention (CYDI)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Bradley A White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.