Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT05022550
Brief Summary:
The current proposal aims to evaluate a novel virtual-reality-based (VR-B) video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. 135 participants under the age of 17 will be enrolled and will be asked to complete up to 6 VR-B sessions.
Detailed Description:
The goal of this proposal is to determine the feasibility of a novel virtual-reality-based biofeedback (VR-B) treatment among youth highly vulnerable to difficulties in emotional regulation. Biofeedback, which involves the provision of real-time information about physiology, is a well-studied approach to enhancing self-regulatory ability, with potential promise for alleviating mental health problems. In children (as well as adults), biofeedback may be ideally facilitated through video game environments, which offer engaging, immersive, yet dynamic environments that can be changed in real-time. Video games are enormously popular with youth, and may represent an important avenue for treatment in adolescent populations. The current proposal aims to evaluate a novel virtual-reality-based video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. Exposure to risk factors known to promote impaired self-regulation, such as child mal-treatment, is nearly endemic in this population. Indeed, 'delinquent' youth (i.e., youth in contact with the justice system) are considerably more likely to meet diagnostic criteria for a range of disorders centrally involving dysregulation of affect or arousal, such as post-traumatic stress disorder, anxiety, depression, oppositional defiant disorder, and many others.
Specific Aims:
* AIM 1: Evaluate the feasibility of a virtual reality treatment for youth
* Hypothesis 1: Study youth receiving treatment with the virtual reality-based paradigm will qualitatively report the experience to be tolerable and positive with minimal discomfort.
* AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions
* Hypothesis 2: Youth receiving virtual reality biofeedback (VRB) treatment will exhibit physiological changes across sessions (e.g., increased heart rate variability or changes in skin conductance responses).
* AIM 3: Identify potential changes in symptom severity across treatment sessions
* Hypothesis 3: Youth receiving virtual reality biofeedback (VRB) treatment will show greater improvements in youth emotion regulation and reduced severity of PTSD mental health symptoms.
Study:
NCT05022550
Study Brief:
Protocol Section:
NCT05022550