Reducing Aggression in Children and Adolescent on an Inpatient Unit

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

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.

Study Overview

• Status: Completed
• Conditions: Anger; Aggression
• Intervention / Treatment: Behavioral: ACT with RAGE-Control

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Cognitive Behavioral Therapy (CBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gonzalez-Heydrich, Joseph, M.D.
• Collaborators: Boston Children's Hospital; Harvard University
• Investigators: Principal Investigator: Elizabeth Wharff, PhD, Boston Children's Hospital

Publications and helpful links

General 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. doi: 10.1007/s10578-005-3494-0.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Estimate): March 12, 2012
• Last Update Submitted That Met QC Criteria: March 8, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: biofeedback; Anger; Aggression; CBT; Videogame
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: X10-06-0278