- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270813
RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RAGE-Control
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.
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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.
Other Names:
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Sham Comparator: Sham videogame
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impressions Global Rating of Improvement (CGI-I)
Time Frame: Up to 3 months post-intervention
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Assesses improvement post treatment, with scores ranging from 1 (very much improved) to 7 (very much worse).
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Up to 3 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impressions Severity of Illness (CGI-S)
Time Frame: Up to 3 months post intervention
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Assess overall burden of illness on a scale from 1 (normal, not ill) to 7 (very severely ill).
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Up to 3 months post intervention
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State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)
Time Frame: Baseline, 2 weeks post treatment, 3 months post treatment
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35 item self-report scale that assesses state anger, trait anger and expression of anger.
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Baseline, 2 weeks post treatment, 3 months post treatment
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Multidimensional Adolescent Satisfaction Scale (MASS)
Time Frame: 2 weeks post treatment, 3 months post treatment
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Measures patient satisfaction with the intervention
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2 weeks post treatment, 3 months post treatment
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Modified Overt Aggression Scale (MOAS)
Time Frame: Baseline, 2 weeks post treatment, 3 months post treatment
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Records the severity of 4 types of aggression: verbal, against property, physical, and against self.
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Baseline, 2 weeks post treatment, 3 months post treatment
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Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Baseline, 2 weeks post treatment, 3 months post treatment
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36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation.
For patients age 10 and older only.
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Baseline, 2 weeks post treatment, 3 months post treatment
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Difficulties in Emotion Regulation Scale - impulse control difficulties
Time Frame: Up to 3 months post intervention
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6 items of the DERS specifically designed to assess impulse control difficulties.
For patients age 10 and older only.
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Up to 3 months post intervention
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Child Behavior Checklist (CBCL) 6-18
Time Frame: Baseline, 2 weeks post treatment, 3 months post treatment
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Empirically based checklist of social competence and behavioral problems, filled out by parents based on recent behavior.
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Baseline, 2 weeks post treatment, 3 months post treatment
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Heart rate
Time Frame: Weekly for 6 weeks
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The computer will record each participant's heart rate while they play the videogame.
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Weekly for 6 weeks
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Emotion Regulation Checklist (ERC)
Time Frame: Up to 3 months post intervention
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24 item parent-report questionnaire regarding a child's ability to assess emotion regulation in the past 1 week.
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Up to 3 months post intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carrie Vaudreuil, MD, Massachusetts General Hospital
Publications and helpful links
General Publications
- Kahn J, Ducharme P, Rotenberg A, Gonzalez-Heydrich J. "RAGE-Control": A Game to Build Emotional Strength. Games Health J. 2013 Feb;2(1):53-7. doi: 10.1089/g4h.2013.0007.
- Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.
- Ducharme P., Wharff E., Kahn J., Hutchinson E., & Logan G. Augmenting anger control therapy with a videogame requiring emotional control: A pilot study on an inpatient psychiatric unit. Adolescent Psychiatry, 2012; 2(4), 323-332.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P000901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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