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

NCT ID: NCT03270813

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2020-12-31

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.

Conditions

Anger; Aggression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Relaxation training plus RAGE-Control

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Relaxation training plus Sham Videogame

Intervention Type: BEHAVIORAL

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.

Interventions

Relaxation training plus 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.

Intervention Type: BEHAVIORAL

Relaxation training plus 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

RAGE-Control; Sham Videogame

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Child Adolescent Psychiatry.

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carrie Vaudreuil

Assistant in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carrie Vaudreuil, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26196556 (View on PubMed)

Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.

Reference Type: BACKGROUND

PMID: 19745492 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 39441503 (View on PubMed)

Other Identifiers

2015P000901

Identifier Type: -

Identifier Source: org_study_id