RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Facial Affect Sensitivity Training for Young Children With CU Traits

Quick Facts

Study Start:2021-02-15
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04159168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Composite intelligence quotient (IQ) score of at least 80 on the Wechsler Abbreviated Scale of Intelligence, Second Edition.
  3. * Any psychotropic medications must be on stable dosing schedule for 2 weeks prior to entry.
  4. * 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).
  1. * Bipolar disorder.
  2. * Current risk for suicide or harm to others.
  3. * Autism spectrum disorder (ASD).
  4. * Currently participating in therapy for CU traits or facial emotion recognition deficits.

Contacts and Locations

Study Contact

Bradley A White, PhD
CONTACT
(205) 348-0251
whiteba@ua.edu
Susan W White, PhD
CONTACT
(205) 348-1967
swwhite1@ua.edu

Principal Investigator

Bradley A White, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

Center for Youth Development and Intervention (CYDI)
Tuscaloosa, Alabama, 35487
United States

Collaborators and Investigators

Sponsor: University of Alabama, Tuscaloosa

  • Bradley A White, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-15
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-02-15
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • 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]

Additional Relevant MeSH Terms

  • Affective Symptoms
  • Empathy