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Reducing Aggression in Children and Adolescent on an Inpatient Unit

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01377948
Enrollment
20
Registered
2011-06-22
Start date
2010-06-30
Completion date
2011-10-31
Last updated
2012-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression, Anger

Keywords

Anger, Aggression, CBT, Videogame, biofeedback

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.

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.

Interventions

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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in State Trait Anger Expression Inventory - Child and Adolescentchange from baseline to just after 5th daily session of the study treatment

Secondary

MeasureTime frameDescription
Change in Percentage of time playing videogame with heart rate under preset thresholdDuring videogame play at end of each of the 5 daily sessions of the study treatment
Therapeutic Helpfulness Questionnaireafter session number 5 of the 5 daily study treatment sessionsTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026