Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gonzalez-Heydrich, Joseph, M.D.
ClinicalTrials.gov Identifier:
NCT01551732
First received: August 31, 2011
Last updated: September 3, 2013
Last verified: September 2013
  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

Further study details as provided by Gonzalez-Heydrich, Joseph, M.D.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 2013
Estimated Primary Completion Date: November 2013 (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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551732

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Gonzalez-Heydrich, Joseph, M.D.
Investigators
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: September 3, 2013
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 October 29, 2014