Clinical Trial: Reducing Aggression in Children and Adolescent on an Inpatient Unit

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric Unit

Brief Summary: The purpose of this study is to determine whether Anger Control Therapy (ACT) with Regulate and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a pediatric inpatient psychiatric unit.

Detailed Summary: Aggression and disruptive behavior are the most common reasons for child and adolescent inpatient psychiatric hospitalization. Aggressive children and adolescents who merit admission to inpatient psychiatric hospitals for treatment typically display dramatic problems with self-regulation that interfere with global adaptive functioning. The goal of this study is to teach self-regulation techniques by combining Cognitive Behavioral Therapy with a biofeedback video game in effort to motivate patients to learn and practice these coping skills, which will translate to decreased feelings of anger and aggression while hospitalized.
Sponsor: Gonzalez-Heydrich, Joseph, M.D.

Current Primary Outcome: Change from baseline in State Trait Anger Expression Inventory - Child and Adolescent [ Time Frame: change from baseline to just after 5th daily session of the study treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Percentage of time playing videogame with heart rate under preset threshold [ Time Frame: During videogame play at end of each of the 5 daily sessions of the study treatment ]
• Therapeutic Helpfulness Questionnaire [ Time Frame: after session number 5 of the 5 daily study treatment sessions ]
  To provide information about feasibility, ratings of perceived helpfulness were collected using the Therapeutic Helpfulness Questionnaire5, which elicits both quantitative and qualitative data in three dimensions: 1) the degree to which it is helpful versus hurtful 2) the degree to which the focus of the treatment was helpful 3) overall satisfaction with the treatment. Participants rated each item from 1 = very unhappy or unhelpful to 7 = very happy or helpful.

Original Secondary Outcome: Same as current

Information By: Gonzalez-Heydrich, Joseph, M.D.

Dates:
Date Received: June 15, 2011
Date Started: June 2010
Date Completion:
Last Updated: March 8, 2012
Last Verified: March 2012