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Reducing Aggression in Children and Adolescent on an Inpatient Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377948
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : March 12, 2012
Boston Children’s Hospital
Harvard University
Information provided by (Responsible Party):
Gonzalez-Heydrich, Joseph, M.D.

Tracking Information
First Submitted Date  ICMJE June 15, 2011
First Posted Date  ICMJE June 22, 2011
Last Update Posted Date March 12, 2012
Study Start Date  ICMJE June 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01377948 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Reducing Aggression in Children and Adolescent on an Inpatient Unit
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anger
  • Aggression
Intervention  ICMJE Behavioral: ACT with RAGE-Control
This is an open trial of ACT with RAGE-Control which is a behavioral intervention. The therapy involves five psychotherapy sessions taking place over five consecutive days.
Other Name: Cognitive Behavioral Therapy (CBT)
Study Arms  ICMJE ACT with RAGE-Control
all subjects are assigned to this arm. This is an open feasability proof of concept trail with a single experimental group with all subjects receiving the intervention being studied.
Intervention: Behavioral: ACT with RAGE-Control
Publications * Sukhodolsky DG, Cardona L, Martin A. Characterizing aggressive and noncompliant behaviors in a children's psychiatric inpatient setting. Child Psychiatry Hum Dev. 2005 Winter;36(2):177-93.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2011)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • consecutive admissions to the psychiatric inpatient unit between the ages of 9 and 17 years of age
  • who were not expected to begin or undergo a change >25% to their antipsychotic or mood stabilizing medications
  • elevated levels of anger as demonstrated by baseline score on the State Trait Anger Expression Inventory - Child and Adolescent (STAXI-CA) combined State-anger and Trait-anger score greater than 30.

Exclusion Criteria:

  • Inability to consent, comprehend, and effectively participate in the study.
  • Gross cognitive impairment due to mental retardation, dementia, or intoxication.
  • Started on an antipsychotic or mood stabilizing drug within 5 days of beginning the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01377948
Other Study ID Numbers  ICMJE X10-06-0278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gonzalez-Heydrich, Joseph, M.D.
Study Sponsor  ICMJE Gonzalez-Heydrich, Joseph, M.D.
Collaborators  ICMJE
  • Boston Children’s Hospital
  • Harvard University
Investigators  ICMJE
Principal Investigator: Elizabeth Wharff, PhD Boston Children’s Hospital
PRS Account Gonzalez-Heydrich, Joseph, M.D.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP