Facial Affect Sensitivity Training (FAST) for Mood Symptoms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Center for Youth Development and Intervention (CYDI), Tuscaloosa, ALMood Symptoms+1 MoreFacial Affect Sensitivity Training (FAST) - Behavioral
Eligibility
6 - 11
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Mood Symptoms
  • Empathy

Treatment Effectiveness

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 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.

Week 5
Change in Clinical Global Impression (CGI) score
Week 5
Change in Callous-Unemotional Traits (R33 phase )
Week 5
Change in Event Related Potential (ERP) signal
Week 5
Change in Eye Gaze (R61 phase primary milestone measure)
Week 5
Change in Facial Emotion Recognition (R61 phase primary milestone measure)
Week 5
Change in Griffith Empathy Measure Score
Week 5
Change in "I Love You" Task

Trial Safety

Trial Design

4 Treatment Groups

Arm 2: R61 No-Treatment Control
1 of 4
Arm 4: R33 Active Control
1 of 4
Arm 1: R61 FAST
1 of 4
Arm 3: R33 FAST
1 of 4

Active Control

Experimental Treatment

168 Total Participants · 4 Treatment Groups

Primary Treatment: Facial Affect Sensitivity Training (FAST) · No Placebo Group · N/A

Arm 1: R61 FAST
Behavioral
Experimental Group · 1 Intervention: Facial Affect Sensitivity Training (FAST) · Intervention Types: Behavioral
Arm 3: R33 FAST
Behavioral
Experimental Group · 1 Intervention: Facial Affect Sensitivity Training (FAST) · Intervention Types: Behavioral
Arm 2: R61 No-Treatment ControlNoIntervention Group · 1 Intervention: Arm 2: R61 No-Treatment Control · Intervention Types:
Arm 4: R33 Active Control
Behavioral
ActiveComparator Group · 1 Intervention: Implicit Gaze Training task (Active control condition) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

University of Alabama, TuscaloosaLead Sponsor
34 Previous Clinical Trials
17,756 Total Patients Enrolled
Bradley A White, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 6 - 11 · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.