FAST for Children with Conduct Problems

Overseen By Susan W White, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Bipolar, Suicide risk, ASD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help children with conduct problems and elevated callous-unemotional (CU) traits, such as lack of empathy or guilt. It focuses on improving how these children recognize emotions, especially fear and sadness, which could lead to better behavior outcomes. The trial involves a unique training called Facial Affect Sensitivity Training (FAST) to address these emotional recognition issues. Children who exhibit CU traits and struggle with recognizing emotions might be suitable candidates. As an unphased trial, this study offers a unique opportunity for children to potentially improve emotional recognition and behavior.

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 prior data suggests that this intervention is safe for children with conduct problems?

Research has shown that the Facial Affect Sensitivity Training (FAST) program is practical and addresses important issues in children with high callous-unemotional (CU) traits. A preliminary study indicated that children generally manage the program well, experiencing no major problems. While specific details about side effects aren't provided, the focus on practicality usually suggests that the program doesn't cause significant negative effects. As FAST continues to develop, ongoing studies will monitor its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAST intervention for children with conduct problems because it targets facial affect sensitivity, a unique approach compared to traditional behavioral therapies. While most current treatments focus on modifying external behaviors through therapy or medication, FAST aims to improve how children perceive and interpret facial emotions, which could lead to better social interactions and reduced conduct issues. Additionally, this approach could complement existing treatments by addressing an underlying cognitive factor, potentially leading to more comprehensive care and improved outcomes for children with conduct problems.

What evidence suggests that this trial's treatments could be effective for conduct problems in children?

Research has shown that Facial Affect Sensitivity Training (FAST), which participants in this trial may receive, could benefit children with high callous-unemotional (CU) traits. Studies have found that FAST helps these children better recognize emotions, especially distress-related ones like fear and sadness. This is crucial because kids with CU traits often struggle to understand these emotions, leading to behavior problems. Early findings suggest that by improving emotion recognition, FAST might also help reduce CU traits themselves. This method trains the brain to better notice emotional signals, potentially improving social interactions and behavior. Meanwhile, another group in this trial will receive an implicit gaze training intervention as an active control to compare the effectiveness of FAST. ^{1 2 3 6 7}

Who Is on the Research Team?

Bradley A White, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Facial Affect Sensitivity Training (FAST)
• Implicit Gaze Training task (Active control condition)

Trial Overview The 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.

How Is the Trial Designed?

Group I: Arm 3: R33 FAST Experimental Treatment 1 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 FAST Experimental Treatment 1 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 Control Active Control 1 Intervention

Individuals in this Arm will not receive any intervention.

Group IV: Arm 4: R33 Active Control Active Control 1 Intervention

Individuals in this Arm will receive the active control component, which is an implicit gaze training intervention.

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

Published Research Related to This Trial

A meta-analysis of 23 fMRI studies involving 606 youths with conduct problems revealed reduced brain activity in areas related to empathic responding and social learning, particularly when viewing angry and fearful facial expressions.

Youths with callous-unemotional traits showed even greater reductions in brain activation in regions associated with facial processing, suggesting that targeting these neural pathways could be important for developing interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion processing in youths with conduct problems: an fMRI meta-analysis. Berluti, K., Ploe, ML., Marsh, AA.[2023]

In a randomized controlled trial involving 74 preschool children, the digital training program Zirkus Empathico significantly improved empathy, emotion recognition, prosocial behavior, and reduced behavioral problems compared to a control group.

The training also enhanced children's neural sensitivity to facial expressions, as indicated by larger P3 amplitudes in response to happy faces, suggesting that Zirkus Empathico effectively boosts social-emotional skills in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on the digital socio-emotional competence training Zirkus Empathico for preschoolers. Naumann, S., Bayer, M., Kirst, S., et al.[2023]

Adolescents with conduct disorder (CD) show abnormal neural responses to negative emotional cues, specifically a pronounced deactivation in the right dorsal anterior cingulate cortex when viewing negative images, compared to healthy controls.

The study indicates that these neural impairments, particularly in the amygdala's responsiveness to negative stimuli, may contribute to difficulties in recognizing emotions and controlling aggressive behavior in individuals with CD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal neural responses to emotional visual stimuli in adolescents with conduct disorder. Sterzer, P., Stadler, C., Krebs, A., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attachment and affect regulation: a framework for family treatment of conduct disorder. Keiley, MK.[2019]

In a study comparing 35 adolescent girls with conduct disorder (CD) to 30 girls without psychiatric disorders, there was no significant difference in facial affect recognition, indicating that girls with CD do not have impairments in recognizing emotions from facial expressions.

However, girls with a history of trauma or neglect showed more errors in recognizing fearful faces, suggesting that trauma may impact emotional recognition abilities, which could be an important area for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognition of facial affect in girls with conduct disorder. Pajer, K., Leininger, L., Gardner, W.[2019]

Children with conduct problems and low callous-unemotional traits (CP/LCU) showed increased amygdala reactivity and slower reaction times when instructed to focus on the eye region of fearful faces, indicating a potential area for therapeutic intervention.

In contrast, children with high callous-unemotional traits (CP/HCU) did not exhibit changes in amygdala response or reaction times when focusing on the eyes, suggesting that their emotional processing may be less malleable compared to those with CP/LCU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural responses to fearful eyes in children with conduct problems and varying levels of callous-unemotional traits. Sebastian, CL., McCrory, EJ., Dadds, MR., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the ability of elementary school-age children to identify emotion in facial expression. Grinspan, D., Hemphill, A., Nowicki, S.[2022]

Children with learning disabilities were found to be less accurate in interpreting emotions from facial expressions and took longer to identify specific emotions compared to their peers without learning disabilities, based on a study involving 96 children.

Younger children, especially those with learning disabilities, struggled more with interpreting emotions like fear and anger, while older children with learning disabilities were quicker but often inaccurate in their interpretations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpretation of emotion from facial expressions in children with and without learning disabilities. Holder, HB., Kirkpatrick, SW.[2019]

The study involved 44 male incarcerated violent offenders and 43 matched controls, revealing that violent offenders had significant difficulties in recognizing facial emotions compared to controls.

Only the group of offenders who underwent sensitivity to emotional expressions training (SEE training) showed marked improvement in recognizing emotions, suggesting that targeted implicit training can enhance emotional recognition abilities in antisocial individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing perceptual insensitivity to facial affect in violent offenders: first evidence for the efficacy of a novel implicit training approach. Schönenberg, M., Christian, S., Gaußer, AK., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9531877/

Facial Affect Sensitivity Training for Young Children with ... We presented open-trial pilot data suggesting the FAST intervention is feasible for children with elevated CU traits and engages the target ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04159168?term=AREA%5BConditionSearch%5D(%22Affective%20Symptoms%22)&rank=1

Facial Affect Sensitivity Training for Young Children With ... 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 ...

3. withpower.com withpower.com/trial/phase-affective-symptoms-1-2021-b87d7

FAST for Children with Conduct Problems 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04159168/facial-affect-sensitivity-training-for-young-children-with-callous-unemotional-traits

Facial Affect Sensitivity Training for Young Children With ... The goal of this study is to test a novel intervention for children ages 6-11 with elevated callous-unemotional (CU) traits. Conduct problems ...

5. researchgate.net researchgate.net/publication/360282089_Facial_Affect_Sensitivity_Training_for_Young_Children_with_Emerging_CU_Traits_An_Experimental_Therapeutics_Approach

(PDF) Facial Affect Sensitivity Training for Young Children ... Relatively poor treatment outcomes have been reported for children with conduct problems and high levels of callous-unemotional (CU) traits ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35486474/

Facial Affect Sensitivity Training for Young Children with ... In the FAST trial, we assert that impaired sensitivity for emotional distress cues (fear and/or sadness) is mechanistically linked to CU traits in children, ...

7. researchgate.net researchgate.net/publication/393520191_Facial_Emotion_Recognition_Trainings_for_Children_and_Adolescents_A_Transdiagnostic_Systematic_Review_and_Meta-Analysis

(PDF) Facial Emotion Recognition Trainings for Children ... This study systematically reviewed and compared the efficacy of facial emotion recognition training programmes for autistic and nonautistic children and ...