Reducing Aggression in Children and Adolescent on an Inpatient Unit

NCT01377948 | Completed Phase 1

• 1 other identifier: X10-06-0278
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anger; Aggression

Keywords

Anger; Aggression; CBT; Videogame; biofeedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

ACT with RAGE-Control

OTHER

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

Interventions

ACT with RAGE-Control BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy (CBT)

ACT with RAGE-Control

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gonzalez-Heydrich, Joseph, M.D.: lead
• Boston Children's Hospital: collaborator
• Harvard University: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

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

  PMID: 16228146 BACKGROUND

MeSH Terms

Conditions

Aggression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elizabeth Wharff, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

US (1)