AngerNCT03270813
RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
A study of Anger and Aggression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anger, Aggression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Problems with anger and/or aggression
- Score of at least 4/10 on phone screen with parents measuring anger and aggression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Anger, Aggression
- Being tested
- Relaxation training plus RAGE-Control, Relaxation training plus Sham Videogame
- Keywords
- Child, Adolescent
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation training plus RAGE-ControlBehavioural
Also called RAGE-Control
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.
Relaxation training plus Sham VideogameBehavioural
Also called Sham Videogame
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.
| Study group | Role | What they receive |
|---|---|---|
| RAGE-Control | Experimental | 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. Receives: Behavioral: Relaxation training plus RAGE-Control |
| Sham videogame | Sham comparator | 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. Receives: Behavioral: Relaxation training plus Sham Videogame |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 3 months post-intervention
Secondary outcomes (9)
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).
Measured: 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.
Measured: Baseline, 2 weeks post treatment, 3 months post treatment
Multidimensional Adolescent Satisfaction Scale (MASS)
Measures patient satisfaction with the intervention
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study startJun 2015
- Primary completionMar 2017
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AngerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry., Harvard University
- Responsible party
- Principal investigator, Carrie Vaudreuil, Massachusetts General Hospital
- Investigators
- Carrie Vaudreuil, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270813
- Sponsor's protocol ID
- 2015P000901
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 26196556Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.
PubMed 19745492Ducharme 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.
Vaudreuil C, Abel MR, Barnett Y, DiSalvo M, Hirshfeld-Becker DR. A Pilot Controlled Trial of Relaxation Training Combined with a Video Game Reinforcing Emotional Regulation to Improve Anger Management in Children and Adolescents. Res Child Adolesc Psychopathol. 2024 Dec;52(12):1847-1859. doi: 10.1007/s10802-024-01259-w. Epub 2024 Oct 23.
PubMed 39441503
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play
- ClinicalTrials.gov ID
- NCT03270813
- Acronym / sponsor ID
- 2015P000901
- Conditions
- Anger, Aggression
- Keywords
- Child, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry., Harvard University
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAGE-Control | Experimental | Behavioral: Relaxation training plus RAGE-ControlThere 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. |
| Sham videogame | Sham comparator | Behavioral: Relaxation training plus Sham VideogameThere 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Problems with anger and/or aggression
- Score of at least 4/10 on phone screen with parents measuring anger and aggression
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation training plus RAGE-ControlAlso: RAGE-ControlRAGE-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. | Behavioural | RAGE-Control |
| Relaxation training plus Sham VideogameAlso: Sham VideogameThe 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. | Behavioural | Sham videogame |
Primary outcome
Clinical Global Impressions Global Rating of Improvement (CGI-I)
Time frame: Up to 3 months post-intervention
Assesses improvement post treatment, with scores ranging from 1 (very much improved) to 7 (very much worse).
9 secondary outcomes
Clinical Global Impressions Severity of Illness (CGI-S)
Time frame: Up to 3 months post intervention
State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Multidimensional Adolescent Satisfaction Scale (MASS)
Time frame: 2 weeks post treatment, 3 months post treatment
Modified Overt Aggression Scale (MOAS)
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Difficulties in Emotion Regulation Scale - impulse control difficulties
Time frame: Up to 3 months post intervention
Child Behavior Checklist (CBCL) 6-18
Time frame: Baseline, 2 weeks post treatment, 3 months post treatment
Heart rate
Time frame: Weekly for 6 weeks
Emotion Regulation Checklist (ERC)
Time frame: Up to 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 26196556Kahn 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.
- Background: PubMed 19745492Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.
- BackgroundDucharme 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.
- Derived from this study: PubMed 39441503Vaudreuil C, Abel MR, Barnett Y, DiSalvo M, Hirshfeld-Becker DR. A Pilot Controlled Trial of Relaxation Training Combined with a Video Game Reinforcing Emotional Regulation to Improve Anger Management in Children and Adolescents. Res Child Adolesc Psychopathol. 2024 Dec;52(12):1847-1859. doi: 10.1007/s10802-024-01259-w. Epub 2024 Oct 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Vaudreuil, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anger and Aggression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions Global Rating of Improvement (CGI-I) (time frame: Up to 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270813, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.