Reducing Aggression in Children and Adolescent on an Inpatient Unit

Phase 1

Completed

• Conditions: Anger; Aggression
• Interventions: Behavioral: ACT with RAGE-Control

• Registration Number: NCT01377948
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-08
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACT with RAGE-Control	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States