Clinical trial NCT01551732: Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
Official title: Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anger
Aggression
Keywords: Anger
Aggression
Biofeedback
Videogame
Lead sponsor: Gonzalez-Heydrich, Joseph, M.D.
Sponsor class: INDIV
First posted: 2012-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 10
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 determine whether adding an interactive biofeedback video game to anger control cognitive behavioral therapy is an effective and feasible treatment.

Detailed description: Current treatments for pathological anger and aggression in youth are lacking in their effectiveness to motivate and engage patients in treatment. As a result, mental health providers encounter challenges due to the limited generalizability of treatment effects to real-world situations outside of the therapist's office. When behavioral treatments fail to show lasting results, children and adolescents are often placed on antipsychotic medication to control their behaviors, which may result in significant toxicity levels and for which there is limited knowledge of the long-term effects on pediatric growth and development. This study tests an interactive biofeedback video game called RAGE-Control (for Regulate and Gain Emotional-Control) as a treatment for youth exhibiting anger and aggression. Treatment with RAGE-Control seeks to motivate children and adolescents to learn and practice coping skills taught in therapy within the environment of a fun and enjoyable video game. The game provides patients a venue to practice self-regulation techniques in response to the increasing stress of the game. Providing patients with the opportunity to refine their self-regulation skills in a fast-paced challenging game is hypothesized to result in greater generalization of therapeutic skills to situations outside of the therapist's office. The goal of the treatment is to decrease patients' feelings of anger, and to increase the patients' levels of control in their emotional and behavioral responses.

Eligibility criteria: Inclusion Criteria:

* Ages 10 to17 years old (inclusive).
* STAXI-CA score \>15 on the Trait Anger subscales.

Exclusion Criteria:

* Inability to consent, comprehend, or effectively participate in the study.
* Cognitive impairment, defined as IQ \< 75.
* Change in mood stabilizing and/or anti-psychotic medication dose within 4 weeks of beginning the study or anticipation of medication changes during the study period (10 weeks).

Primary outcomes:
measure: State Trait Anger Expression Inventory - Child and Adolescent
timeFrame: Baseline and two weeks Post treatment
Secondary outcomes:
measure: Disruptive Behavior Disorder Rating Scale (DBDRS)
timeFrame: Baseline and two weeks post treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joseph Gonzalez-Heydrich
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Joseph W Gonzalez-Heydrich, MD
role: STUDY_DIRECTOR
References:
citation: Ducharme P, Kahn J, Vaudreuil C, Gusman M, Waber D, Ross A, Rotenberg A, Rober A, Kimball K, Peechatka AL, Gonzalez-Heydrich J. A "Proof of Concept" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training. Front Psychiatry. 2021 Sep 1;12:591906. doi: 10.3389/fpsyt.2021.591906. eCollection 2021.