Reducing Aggression in Children and Adolescent on an Inpatient Unit

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anger, Aggression

Intervention / Treatment
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* Behavioral: ACT with RAGE-Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ACT with RAGE-Control<br>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<br>* 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.<br>* Other names: Cognitive Behavioral Therapy (CBT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in State Trait Anger Expression Inventory - Child and Adolescent |  | change from baseline to just after 5th daily session of the study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of time playing videogame with heart rate under preset threshold |  | During videogame play at end of each of the 5 daily sessions of the study treatment | 
| 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. | after session number 5 of the 5 daily study treatment sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anger, Aggression, CBT, Videogame, biofeedback