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FAST for Children with Conduct Problems

N/A

Recruiting

Led By Bradley A White, PhD

Research Sponsored by University of Alabama, Tuscaloosa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial is testing a new intervention for children with elevated callous-unemotional traits. These traits are common in children who have conduct problems and can lead to poorer outcomes, even with well-established treatments. The new intervention, called FAST, is designed to improve facial affect recognition, which is thought to be linked to callous-unemotional traits. The goal is to see if FAST can reduce callous-unemotional traits and improve behavioral outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a behavioral intervention focusing on emotion recognition training rather than medication or invasive procedures, traditional physical side effects are not expected. However, the impact on mood and behavior will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Callous-Unemotional Traits (R33 phase )

Change in Eye Gaze (R61 phase primary milestone measure)

Change in Facial Emotion Recognition (R61 phase primary milestone measure)

Secondary outcome measures

Change in "I Love You" Task

Change in Clinical Global Impression (CGI) score

Change in Event Related Potential (ERP) signal

+1 more

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama, TuscaloosaLead Sponsor

44 Previous Clinical Trials

19,348 Total Patients Enrolled

Bradley A White, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Facial Affect Sensitivity Training (FAST) Clinical Trial Eligibility Overview. Trial Name: NCT04159168 — N/A

Mood Symptoms Research Study Groups: Arm 3: R33 FAST, Arm 1: R61 FAST, Arm 2: R61 No-Treatment Control, Arm 4: R33 Active Control

Mood Symptoms Clinical Trial 2023: Facial Affect Sensitivity Training (FAST) Highlights & Side Effects. Trial Name: NCT04159168 — N/A

Facial Affect Sensitivity Training (FAST) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04159168 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic objectives are being sought by this clinical trial?

"The primary goal of this trial is to evaluate the modification in Callous-Unemotional Traits over a five week period. Pre-treatment, post-treatment and 3 month follow up observations will be conducted, as well as periodic assessments during intervention. Other objectives include alteration in Clinical Global Impression score, reciprocal eye contact between parent and child (I Love You Task) and Event Related Potential signal via electroencephalography for early emotion processing of facial expressions."

Answered by AI

Does the study include seniors aged 75 and above?

"To meet the prerequisites for inclusion in this research, participants must be between 6 and 11 years old."

Answered by AI

Are there any opportunities to enroll in this clinical trial at present?

"Current information on clinicaltrials.gov indicates that this trial is actively searching for suitable candidates, since it was posted on February 15th 2021 and last revised a day later."

Answered by AI

How many participants are involved in this clinical trial?

"Indeed, clinicaltrials.gov clearly states that this medical trial is presently recruiting patients to participate. The initial posting was made on February 15th 2021 and the details were last updated one day after on February 16th 2021. A total of 168 individuals need to be enlisted from a single site."

Answered by AI

Is it possible for me to become involved in this clinical investigation?

"Eligibility requirements for this clinical trial stipulate that persons with alexithymia, aged 6-11 years old may apply. At present, 168 individuals are being recruited to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits

Bradley A. White 2021. "Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04159168.