Clinical trial NCT01377948: Reducing Aggression in Children and Adolescent on an Inpatient Unit
Official title: Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anger
Aggression
Keywords: Anger
Aggression
CBT
Videogame
biofeedback
Lead sponsor: Gonzalez-Heydrich, Joseph, M.D.
Sponsor class: INDIV
Collaborators: name: Boston Children's Hospital
name: Harvard University
First posted: 2011-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in State Trait Anger Expression Inventory - Child and Adolescent
timeFrame: change from baseline to just after 5th daily session of the study treatment
Secondary outcomes:
measure: Change in Percentage of time playing videogame with heart rate under preset threshold
timeFrame: During videogame play at end of each of the 5 daily sessions of the study treatment
measure: Therapeutic Helpfulness Questionnaire
timeFrame: after session number 5 of the 5 daily study treatment sessions
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Elizabeth Wharff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.