Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anger Aggression |
Behavioral: ACT Behavioral: ACT with RAGE-Control |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger |
- State Trait Anger Expression Inventory - Child and Adolescent [ Time Frame: Baseline and two weeks Post treatment ] [ Designated as safety issue: No ]This is a 35 item self-report measure of patients' subjective feelings of anger and aggression administered at the baseline assessment prior to the first session and again two weeks post treatment.
- Disruptive Behavior Disorder Rating Scale (DBDRS) [ Time Frame: Baseline and two weeks post treatment ] [ Designated as safety issue: No ]This is an interview conducted by an investigator who is blinded to the patient's treatment assignment. The investigator conducts this interview with the patient's parent/ guardian at baseline prior to the first session and again two weeks post treatment.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Anger Control Therapy
10 session manualized cognitive behavioral anger control therapy
|
Behavioral: ACT
10 session manualized cognitive behavioral anger control therapy
Other Name: CBT
|
|
Experimental: ACT with RAGE-Control
10 session manualized cognitive behavioral anger control therapy augmented with an interactive biofeedback videogame.
|
Behavioral: ACT with RAGE-Control
10 session manualized cognitive behavioral anger control therapy augmented with interactive biofeedback videogame.
Other Name: CBT and biofeedback
|
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| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Peter W Ducharme, MSW | 617-355-6680 | peter.ducharme@childrens.harvard.edu |
| Contact: Grace logan, BA | 617-355-6680 | grace.logan@childrens.harvard.edu |
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Peter W Ducharme, MSW 617-355-6680 peter.ducharme@childrens.harvard.edu | |
| Principal Investigator: Peter W Ducharme, MSW | |
| Sub-Investigator: Joseph Gonzalez-Heydrich, MD | |
| Principal Investigator: | Peter W Ducharme, MSW | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | Gonzalez-Heydrich, Joseph, M.D. |
| ClinicalTrials.gov Identifier: | NCT01551732 History of Changes |
| Other Study ID Numbers: | P00000440 |
| Study First Received: | August 31, 2011 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Gonzalez-Heydrich, Joseph, M.D.:
|
Anger Aggression Biofeedback Videogame |
Additional relevant MeSH terms:
|
Aggression Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013