An interventional study of Relaxation training plus RAGE-Control and Relaxation training plus Sham Videogame in Anger and Aggression, sponsored by Massachusetts General Hospital. Status unknown at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
248 studies on the registry are indexed under Aggression; 41 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 221 interventional studies indexed under Aggression.
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There are 6 research intervention sessions, which will involve Relaxation training plus RAGE-Control. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, introduction to the RAGE-Control videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.
Behavioral: Relaxation training plus RAGE-Control
There are 6 research intervention sessions, which will involve Relaxation training plus Sham videogame. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, an introduction to the Sham videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.
Behavioral: Relaxation training plus Sham Videogame
RAGE-Control is a biofeedback videogame in which players shoot at enemies while avoiding allies. The player's baseline heart rate is taken before the game and entered into the computer. During the game, the player wears a heart rate monitor, and if the player's heart rate rises above baseline, they are unable to shoot. The player must use relaxation skills to decrease their heart rate below the baseline before they can resume play. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the RAGE-Control videogame.
Also known as: RAGE-Control
The Sham videogame is a videogame in which players shoot at enemies while avoiding allies. The player wears a heart rate monitor during the game, but the heart rate does not affect the functioning of the game in any way. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the Sham videogame.
Also known as: Sham Videogame
Clinical Global Impressions Global Rating of Improvement (CGI-I)
Assesses improvement post treatment, with scores ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Up to 3 months post-intervention
Clinical Global Impressions Severity of Illness (CGI-S)
Assess overall burden of illness on a scale from 1 (normal, not ill) to 7 (very severely ill).
Time frame: Up to 3 months post intervention
State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)
35 item self-report scale that assesses state anger, trait anger and expression of anger.
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Multidimensional Adolescent Satisfaction Scale (MASS)
Measures patient satisfaction with the intervention
Time frame: 2 weeks post treatment, 3 months post treatment
Modified Overt Aggression Scale (MOAS)
Records the severity of 4 types of aggression: verbal, against property, physical, and against self.
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Difficulties in Emotion Regulation Scale (DERS)
36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. For patients age 10 and older only.
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Difficulties in Emotion Regulation Scale - impulse control difficulties
6 items of the DERS specifically designed to assess impulse control difficulties. For patients age 10 and older only.
Time frame: Up to 3 months post intervention
Child Behavior Checklist (CBCL) 6-18
Empirically based checklist of social competence and behavioral problems, filled out by parents based on recent behavior.
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Heart rate
The computer will record each participant's heart rate while they play the videogame.
Time frame: Weekly for 6 weeks
Emotion Regulation Checklist (ERC)
24 item parent-report questionnaire regarding a child's ability to assess emotion regulation in the past 1 week.
Time frame: Up to 3 months post intervention
Plan to share: Undecided
The record gives a start of Jun 2015, a primary completion of Mar 2017 and a completion of Dec 2020. It does not say whether these dates are actual or estimated.
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