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OpenTrials
Completed

NCT Number: NCT01377948

Reducing Aggression in Children and Adolescent on an Inpatient 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.

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Key information

Conditions

Anger Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Social Behavior

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cognitive Behavioral Therapy (CBT)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Therapeutic Helpfulness Questionnaire

    Time frame: after session number 5 of the 5 daily study treatment sessions

    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.

Sponsors and collaborators

Lead sponsor

Gonzalez-Heydrich, Joseph, M.D.

Indiv

Collaborators

  • Boston Children's Hospital
  • Harvard University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2011
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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