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

Primary Purpose

Anger, Aggression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation training plus RAGE-Control
Relaxation training plus Sham Videogame
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anger focused on measuring Child, Adolescent

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RAGE-Control

Sham videogame

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
Multidimensional Adolescent Satisfaction Scale (MASS)
Measures patient satisfaction with the intervention
Modified Overt Aggression Scale (MOAS)
Records the severity of 4 types of aggression: verbal, against property, physical, and against self.
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.
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.
Child Behavior Checklist (CBCL) 6-18
Empirically based checklist of social competence and behavioral problems, filled out by parents based on recent behavior.
Heart rate
The computer will record each participant's heart rate while they play the videogame.
Emotion Regulation Checklist (ERC)
24 item parent-report questionnaire regarding a child's ability to assess emotion regulation in the past 1 week.

Full Information

First Posted
June 28, 2017
Last Updated
July 1, 2020
Sponsor
Massachusetts General Hospital
Collaborators
American Academy of Child Adolescent Psychiatry., Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT03270813
Brief Title
RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
Official Title
RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Academy of Child Adolescent Psychiatry., Harvard University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Aggression
Keywords
Child, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RAGE-Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham videogame
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation training plus RAGE-Control
Other Intervention Name(s)
RAGE-Control
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation training plus Sham Videogame
Other Intervention Name(s)
Sham Videogame
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Global Impressions Global Rating of Improvement (CGI-I)
Description
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
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Severity of Illness (CGI-S)
Description
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
Title
State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)
Description
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
Title
Multidimensional Adolescent Satisfaction Scale (MASS)
Description
Measures patient satisfaction with the intervention
Time Frame
2 weeks post treatment, 3 months post treatment
Title
Modified Overt Aggression Scale (MOAS)
Description
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
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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
Title
Difficulties in Emotion Regulation Scale - impulse control difficulties
Description
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
Title
Child Behavior Checklist (CBCL) 6-18
Description
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
Title
Heart rate
Description
The computer will record each participant's heart rate while they play the videogame.
Time Frame
Weekly for 6 weeks
Title
Emotion Regulation Checklist (ERC)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Vaudreuil, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26196556
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.
Results Reference
background
PubMed Identifier
19745492
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.
Results Reference
background
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.
Results Reference
background

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

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