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The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation skills as an intervention for symptoms of anger and aggression in children and adolescents. Half of the research participants will learn relaxation techniques and practice them using the RAGE-Control videogame. The other half of the participants will learn relaxation techniques and play a similar videogame without the biofeedback component. The investigators hypothesize that participants in the RAGE-Control group will show a greater reduction in symptoms of anger and aggression than those in the non-RAGE-Control group.
Experiencing mild anger and aggression in frustrating situations is typical in childhood; however, over time most children develop the capacity to regulate their anger in emotionally provoking situations. Those who continue to struggle with emotional and behavioral regulation are at heightened risk for social isolation, delinquency, substance abuse, and academic problems later in life. Moreover, adults who were aggressive as children experience poor physical and mental health, and may find limited career opportunities. Although anger regulation is a common and clinically significant psychiatric concern for children and adolescents, effective treatment options are limited. As a result, clinicians increasingly rely on psychotropic medications to blunt anger. Psychotropic medications can reduce anger and aggression in the short term, but they fail in the long-term goal of teaching self-regulation, and carry the risk of serious side-effects, including obesity, metabolic syndrome, and type II diabetes. However, engaging youth with anger issues in therapeutic treatments can be difficult, with high rates of attrition. These difficulties underline the need for innovative treatments that can effectively engage patients and enhance their ability to control their emotions and behaviors. In response to this need, clinicians at Boston Children's Hospital developed Regulate and Gain Emotional Control (RAGE-Control), a therapeutic videogame that requires players to maintain low levels of physiologic arousal while rapidly reacting to incoming stimuli and inhibiting erroneous responses. It was initially designed for use with Cognitive Behavioral Therapy (CBT) to motivate children to remain engaged in therapy, and to foster the learning, practice, and generalization of self-regulation skills in the midst of frustrating or anger provoking situations. Pilot data from an open label trial of RAGE-Control on a pediatric psychiatric inpatient unit demonstrated improvement in patient self-reported anger and aggression after 5 sessions of CBT with RAGE-Control, when compared with a treatment as usual group. A subsequent outpatient randomized controlled trial comparing CBT with RAGE-Control to CBT with a sham videogame demonstrated that patients who participated in the RAGE-Control intervention had significantly greater improvements in overt aggression and oppositionality, parental stress, and family atmosphere. The participants in the RAGE-Control group also had fewer drop outs, and twice as many treatment responders as the participants in the control arm.
Age
7 - 17 years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
June 1, 2015
Primary Completion Date
March 1, 2017
Completion Date
December 1, 2020
Last Updated
July 7, 2020
40
ESTIMATED participants
Relaxation training plus RAGE-Control
BEHAVIORAL
Relaxation training plus Sham Videogame
BEHAVIORAL
Lead Sponsor
Massachusetts General Hospital
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04079179