Affective SymptomsNCT04159168
Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits
A study testing Facial Affect Sensitivity Training (FAST) in people with Affective Symptoms and Empathy, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Affective Symptoms, Empathy
- What is being tested?
- Facial Affect Sensitivity Training (FAST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A standard score less than or equal to 9 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 72 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 a total score of at least 2 on the 4 CU items of the Antisocial Process Screening Device (APSD), Parent Version, with caregiver-endorsed distress or impairment required for scores of exactly 2.
Who cannot join
- Bipolar disorder. Current risk for suicide or harm to others. Autism spectrum disorder (ASD) diagnosis. Currently participating in therapy for CU traits or facial emotion recognition deficits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Youth Development and Intervention (CYDI)
Tuscaloosa, Alabama, 35487
About this study
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.
Read the 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.
- Conditions
- Affective Symptoms, Empathy
- Being tested
- Facial Affect Sensitivity Training (FAST), Implicit Gaze Training task (Active control condition)
- 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]
- Medical subject headings
- Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Affect Sensitivity Training (FAST)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Arm 1: R61 FAST | Experimental | 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. Receives: Behavioral: Facial Affect Sensitivity Training (FAST) |
| Arm 2: R61 No-Treatment Control | No intervention | Individuals in this Arm will not receive any intervention. |
| Arm 3: R33 FAST | Experimental | 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). Receives: Behavioral: Facial Affect Sensitivity Training (FAST) |
| Arm 4: R33 Active Control | Active comparator | Individuals in this Arm will receive the active control component, which is an implicit gaze training intervention. Receives: Behavioral: Implicit Gaze Training task (Active control condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: ERPs will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in both R61 and R33 phases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start15 Feb 2021
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Affective SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley A. White, University of Alabama, Tuscaloosa
- Investigators
- Bradley A White, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159168
- Sponsor's protocol ID
- MH117192
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 35486474
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Affect Sensitivity Training for Young Children With CU Traits
- ClinicalTrials.gov ID
- NCT04159168
- Acronym / sponsor ID
- MH117192
- 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]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: R61 FAST | Experimental | Behavioral: Facial Affect Sensitivity Training (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. |
| Arm 2: R61 No-Treatment Control | No intervention | –Individuals in this Arm will not receive any intervention. |
| Arm 3: R33 FAST | Experimental | Behavioral: Facial Affect Sensitivity Training (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). |
| Arm 4: R33 Active Control | Active comparator | Behavioral: Implicit Gaze Training task (Active control condition)Individuals in this Arm will receive the active control component, which is an implicit gaze training intervention. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A standard score less than or equal to 9 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 72 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 a total score of at least 2 on the 4 CU items of the Antisocial Process Screening Device (APSD), Parent Version, with caregiver-endorsed distress or impairment required for scores of exactly 2.
Key exclusion criteria (1 listed)
- Bipolar disorder. Current risk for suicide or harm to others. Autism spectrum disorder (ASD) diagnosis. Currently participating in therapy for CU traits or facial emotion recognition deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Arm 1: R61 FAST, Arm 3: R33 FAST |
| 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. | Behavioural | Arm 4: R33 Active Control |
Primary outcome
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.
Recognition of facial emotional expressions will be indexed based on accuracy of matching emotion expressions on the FACES and Dynamic FER tasks.
Change in Eye Gaze (R61 phase primary milestone measure)
Time frame: 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.
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.
Change in Callous-Unemotional Traits (R33 phase primary outcome)
Time frame: 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.
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.
4 secondary outcomes
Change in Griffith Empathy Measure Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: ERPs will be assessed at eligibility, post-treatment (end of 5 weeks), and 3-month follow-up in both R61 and R33 phases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 35486474White 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.
- University of Alabama Center for Youth Development and Intervention (CYDI) Website (Study location)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley A White, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Affect Sensitivity Training (FAST) in people with Affective Symptoms and Empathy, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.