Clinical trial NCT03270813: RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
Official title: RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anger
Aggression
Keywords: Child
Adolescent
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Child Adolescent Psychiatry.
name: Harvard University
First posted: 2017-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impressions Global Rating of Improvement (CGI-I)
timeFrame: Up to 3 months post-intervention
Secondary outcomes:
measure: Clinical Global Impressions Severity of Illness (CGI-S)
timeFrame: Up to 3 months post intervention
measure: State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)
timeFrame: Baseline, 2 weeks post treatment, 3 months post treatment
measure: Multidimensional Adolescent Satisfaction Scale (MASS)
timeFrame: 2 weeks post treatment, 3 months post treatment
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: Baseline, 2 weeks post treatment, 3 months post treatment
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, 2 weeks post treatment, 3 months post treatment
measure: Difficulties in Emotion Regulation Scale - impulse control difficulties
timeFrame: Up to 3 months post intervention
measure: Child Behavior Checklist (CBCL) 6-18
timeFrame: Baseline, 2 weeks post treatment, 3 months post treatment
measure: Heart rate
timeFrame: Weekly for 6 weeks
measure: Emotion Regulation Checklist (ERC)
timeFrame: Up to 3 months post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Carrie Vaudreuil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.
citation: 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.