Reducing Aggression in Children and Adolescent on an Inpatient Unit
Primary Purpose
Anger, Aggression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACT with RAGE-Control
Sponsored by
About this trial
This is an interventional treatment trial for Anger focused on measuring Anger, Aggression, CBT, Videogame, biofeedback
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ACT with RAGE-Control
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline in State Trait Anger Expression Inventory - Child and Adolescent
Secondary Outcome Measures
Change in Percentage of time playing videogame with heart rate under preset threshold
Therapeutic Helpfulness Questionnaire
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.
Full Information
NCT ID
NCT01377948
First Posted
June 15, 2011
Last Updated
March 8, 2012
Sponsor
Gonzalez-Heydrich, Joseph, M.D.
Collaborators
Boston Children's Hospital, Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT01377948
Brief Title
Reducing Aggression in Children and Adolescent on an Inpatient Unit
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gonzalez-Heydrich, Joseph, M.D.
Collaborators
Boston Children's Hospital, Harvard University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Aggression
Keywords
Anger, Aggression, CBT, Videogame, biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT with RAGE-Control
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
ACT with RAGE-Control
Other Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Therapeutic Helpfulness Questionnaire
Description
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.
Time Frame
after session number 5 of the 5 daily study treatment sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Wharff, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16228146
Citation
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. doi: 10.1007/s10578-005-3494-0.
Results Reference
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Reducing Aggression in Children and Adolescent on an Inpatient Unit
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