Reducing Aggression in Children and Adolescent on an Inpatient Unit

Aggression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377948
• Other study ID #: X10-06-0278
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2011
• Last updated: March 8, 2012
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Gonzalez-Heydrich, Joseph, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Anger

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Gonzalez-Heydrich, Joseph, M.D.	Children's Hospital Boston, Harvard University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No