Reducing Aggression in Children and Adolescent on an Inpatient Unit

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital Boston
Harvard University
Information provided by (Responsible Party):
Gonzalez-Heydrich, Joseph, M.D.
ClinicalTrials.gov Identifier:
NCT01377948
First received: June 15, 2011
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Anger
Aggression
Behavioral: ACT with RAGE-Control
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric Unit

Further study details as provided by Gonzalez-Heydrich, Joseph, M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Therapeutic Helpfulness Questionnaire [ Time Frame: after session number 5 of the 5 daily study treatment sessions ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cognitive Behavioral Therapy (CBT)

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377948

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Gonzalez-Heydrich, Joseph, M.D.
Children's Hospital Boston
Harvard University
Investigators
Principal Investigator: Elizabeth Wharff, PhD Children's Hospital Boston
  More Information

Publications:
Responsible Party: Gonzalez-Heydrich, Joseph, M.D.
ClinicalTrials.gov Identifier: NCT01377948     History of Changes
Other Study ID Numbers: X10-06-0278
Study First Received: June 15, 2011
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gonzalez-Heydrich, Joseph, M.D.:
Anger
Aggression
CBT
Videogame
biofeedback

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 23, 2014