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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.

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.

Condition or disease Intervention/treatment Phase
Anger Aggression Behavioral: ACT with RAGE-Control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric Unit
Study Start Date : June 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
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.
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01377948

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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Gonzalez-Heydrich, Joseph, M.D.
Boston Children's Hospital
Harvard University
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Principal Investigator: Elizabeth Wharff, PhD Boston Children's Hospital
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Responsible Party: Gonzalez-Heydrich, Joseph, M.D. Identifier: NCT01377948    
Other Study ID Numbers: X10-06-0278
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012
Keywords provided by Gonzalez-Heydrich, Joseph, M.D.:
Additional relevant MeSH terms:
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Behavioral Symptoms