RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play

Conditions
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Anger, Aggression

Intervention / Treatment
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* Behavioral: Relaxation training plus RAGE-Control
* Behavioral: Relaxation training plus Sham Videogame


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Problems with anger and/or aggression Score of at least 4/10 on phone screen with parents measuring anger and aggression Exclusion Criteria: Changes in dosing of psychotropic medications within the 8 weeks prior to the start of the study, or anticipated medication changes during the study. Starting therapy within the 8 weeks prior to starting the study, or anticipated new therapy beginning during the study. Actively participating in any type of Cognitive Behavioral Therapy for less than 12 weeks and/or attending Cognitive Behavioral Therapy weekly or more. Intellectual disability (IQ < 80) Suicidal ideation Homicidal ideation Psychosis/meets criteria for psychotic disorder

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAGE-Control<br>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<br>* 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.<br>* Other names: RAGE-Control;|
| Sham Comparator: Sham videogame<br>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<br>* 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.<br>* Other names: Sham Videogame;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline, 2 weeks post treatment, 3 months post treatment | 
| Multidimensional Adolescent Satisfaction Scale (MASS) | Measures patient satisfaction with the intervention | 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. | 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. | 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. | 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. | 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. | 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. | Up to 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Adolescent