Reducing Aggression in Children and Adolescent on an Inpatient Unit

NCT ID: NCT01377948

Last Updated: 2012-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Anger Aggression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

ACT with RAGE-Control

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Gonzalez-Heydrich, Joseph, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Wharff, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16228146 (View on PubMed)

Other Identifiers

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X10-06-0278

Identifier Type: -

Identifier Source: org_study_id

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