168 Participants Needed

FAST for Children with Conduct Problems

BA
SW
Overseen BySusan W White, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama, Tuscaloosa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that any psychotropic medications (drugs that affect mood, perception, or behavior) must be on a stable dosing schedule for 2 weeks before joining. So, you won't have to stop taking them, but they need to be stable.

What data supports the effectiveness of the treatment Facial Affect Sensitivity Training (FAST) for children with conduct problems?

Research shows that training programs to improve the ability to read emotions in facial expressions can significantly enhance children's skills in this area, which may help address conduct problems linked to difficulties in recognizing emotions.12345

How is the FAST treatment different from other treatments for children with conduct problems?

FAST (Facial Affect Sensitivity Training) is unique because it focuses on improving the ability to recognize and respond to facial expressions, which is often impaired in children with conduct problems. This approach targets specific brain regions involved in emotion processing and social learning, making it different from other treatments that may not address these neural dysfunctions directly.678910

Research Team

BA

Bradley A White, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for children aged 6-11 with high callous-unemotional traits, which include a lack of empathy or guilt. They must have difficulty recognizing emotions on faces, an IQ score of at least 80, and stable psychotropic medication use if applicable. Children with bipolar disorder, autism, current therapy for CU traits or emotion recognition deficits are excluded.

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.
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).
My mental health medication doses have been stable for at least 2 weeks.
See 1 more

Exclusion Criteria

You are currently receiving treatment for facial emotion recognition deficits or traits of CU (callous-unemotional) behavior.
I have been diagnosed with bipolar disorder.
You have autism spectrum disorder (ASD).
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase Treatment

Participants receive the FAST intervention to improve facial affect sensitivity in children with elevated CU traits.

5 weeks
Approximately every other week

R33 Phase Treatment

Replication of FAST target engagement with a new high-CU sample and evaluation of FAST intervention compared to an active control condition.

5 weeks
Approximately every other week

Follow-up

Participants are monitored for changes in CU traits and empathy measures after treatment.

3 months
Post-treatment and 3-month follow-up

Treatment Details

Interventions

  • Facial Affect Sensitivity Training (FAST)
  • Implicit Gaze Training task (Active control condition)
Trial OverviewThe study tests Facial Affect Sensitivity Training (FAST) against an Implicit Gaze Training task to improve emotional distress cue recognition in children with CU traits. It aims to see if improving how these kids recognize and respond to fear and sadness can reduce their CU behaviors.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3: R33 FASTExperimental Treatment1 Intervention
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).
Group II: Arm 1: R61 FASTExperimental Treatment1 Intervention
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.
Group III: Arm 2: R61 No-Treatment ControlActive Control1 Intervention
Individuals in this Arm will not receive any intervention.
Group IV: Arm 4: R33 Active ControlActive Control1 Intervention
Individuals in this Arm will receive the active control component, which is an implicit gaze training intervention.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials
49
Recruited
17,900+

Findings from Research

A structured intervention program significantly improved children's ability to read emotions in facial expressions, with 30 participants completing 6 sessions over 4 weeks.
The improvement in reading facial expressions was linked to reduced social anxiety and increased self-worth in girls, while boys showed a negative relationship between self-concept and improvement, suggesting the need for tailored approaches in interventions.
Improving the ability of elementary school-age children to identify emotion in facial expression.Grinspan, D., Hemphill, A., Nowicki, S.[2022]
Research suggests that attachment and affect regulation play significant roles in the development of conduct disorder (CD) in adolescents, indicating that addressing these factors could enhance treatment outcomes.
An attachment- and affect regulation-based intervention has been developed for multiple-family groups, showing preliminary evidence of effectiveness in treating CD among parents and incarcerated adolescents.
Attachment and affect regulation: a framework for family treatment of conduct disorder.Keiley, MK.[2019]
A treatment package that included graduated exposure, modeling, and social attention effectively helped two children with autism learn to tolerate skin care products, reducing their fearful responses.
The study used changing criteria and multiple baseline designs to measure both avoidance and acceptance responses, demonstrating that the intervention improved the children's ability to accept skin care applications.
The effects of graduated exposure, modeling, and contingent social attention on tolerance to skin care products with two children with autism.Ellis, EM., Ala'i-Rosales, SS., Glenn, SS., et al.[2019]

References

Improving the ability of elementary school-age children to identify emotion in facial expression. [2022]
Attachment and affect regulation: a framework for family treatment of conduct disorder. [2019]
The effects of graduated exposure, modeling, and contingent social attention on tolerance to skin care products with two children with autism. [2019]
Addressing perceptual insensitivity to facial affect in violent offenders: first evidence for the efficacy of a novel implicit training approach. [2014]
Interpretation of emotion from facial expressions in children with and without learning disabilities. [2019]
Emotion processing in youths with conduct problems: an fMRI meta-analysis. [2023]
A randomized controlled trial on the digital socio-emotional competence training Zirkus Empathico for preschoolers. [2023]
Abnormal neural responses to emotional visual stimuli in adolescents with conduct disorder. [2022]
Recognition of facial affect in girls with conduct disorder. [2019]
Neural responses to fearful eyes in children with conduct problems and varying levels of callous-unemotional traits. [2019]