Facial Affect Sensitivity Training for Young Children with Emerging CU Traits: An Experimental Therapeutics Approach

ABSTRACT

Objective

This article delineates best practices in the application of the experimental therapeutics framework for evaluating interventions within the context of randomized controlled trials (RCTs), offering a methodological primer and guiding framework for this approach. We illustrate these practices using an ongoing clinical trial conducted within the framework of a National Institute of Mental Health exploratory phased-innovation award for the development of psychosocial therapeutic interventions for mental disorders (R61/R33), describing the implementation of a novel “Facial Affect Sensitivity Training” (FAST) intervention for children with callous-unemotional (CU) traits. CU traits (e.g., lack of guilt or remorse, low empathy, shallow affect) are an established risk factor for persistent and severe youth misconduct, which reflect impairment in identified neurocognitive mechanisms that interfere with child socialization, and predict poor treatment outcomes, even with well-established treatments for disruptive behavior.

Method

We outline the stages, goals, and best practices for an experimental therapeutics framework. 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, and that by targeting sensitivity to facial affect directly via a computerized automated feedback and incentive system, we can exert downstream effects on CU traits.

Results

In the context of an open pilot trial, we found preliminary support for feasibility and mechanism engagement using FAST.

Conclusions

We summarize pilot study limitations and how they are being addressed in the R61/R33 RCTs, as well as challenges and future directions for psychosocial experimental therapeutics.

Acknowledgments

Special thanks to Kirby Deater Deckard, Robin Panneton, and Thomas Ollendick for their invaluable input and support during the early stages of development of the FAST proposal.

Disclosure Statement

No potential conflict of interest was reported by the authors.

Ethics Approval

This study was approved by the Institutional Review Board of The University of Alabama IRB# 19-10-2933/

Additional information

Funding

Pilot data collection was supported through grants to B. White from the Virginia Tech Institute for Society, Culture and Environment and the Center for Peace Studies and Violence Prevention. The R61/R33 clinical trial described herein is supported by the National Institute of Mental Health [grant number 5R61MH117192-02].