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

NCT03270813 | Unknown

• 1 other identifier: 2015P000901
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anger; Aggression

Keywords

Child; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 3 months post-intervention

Secondary Outcomes (9)

• Clinical Global Impressions Severity of Illness (CGI-S)

  Up to 3 months post intervention

• State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)

  Baseline, 2 weeks post treatment, 3 months post treatment

• Multidimensional Adolescent Satisfaction Scale (MASS)

  2 weeks post treatment, 3 months post treatment

• Modified Overt Aggression Scale (MOAS)

  Baseline, 2 weeks post treatment, 3 months post treatment

• Difficulties in Emotion Regulation Scale (DERS)

  Baseline, 2 weeks post treatment, 3 months post treatment

Study Arms (2)

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.

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.

Behavioral: Relaxation training plus Sham Videogame

Interventions

Relaxation training plus RAGE-Control 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.

Also known as: RAGE-Control

RAGE-Control

Relaxation training plus Sham Videogame 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.

Also known as: Sham Videogame

Sham videogame

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Problems with anger and/or aggression
• Score of at least 4/10 on phone screen with parents measuring anger and aggression

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard University: collaborator
• American Academy of Child Adolescent Psychiatry.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 26196556 BACKGROUND

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

  PMID: 19745492 BACKGROUND

• 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.

  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.

  PMID: 39441503 DERIVED

MeSH Terms

Conditions

Aggression

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carrie Vaudreuil, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychiatry

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: September 1, 2017
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)