AngerPhase 1NCT01377948
Reducing Aggression in Children and Adolescent on an Inpatient Unit
A Phase 1 study of Anger and Aggression, run by Gonzalez-Heydrich, Joseph, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anger, Aggression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric 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.
Read the 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.
- Conditions
- Anger, Aggression
- Being tested
- ACT with RAGE-Control
- Keywords
- Anger, Aggression, CBT, Videogame, biofeedback
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT with RAGE-ControlBehavioural
Also called Cognitive Behavioral Therapy (CBT)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ACT with RAGE-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in State Trait Anger Expression Inventory - Child and Adolescent
Measured: 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
Measured: During videogame play at end of each of the 5 daily sessions of the study treatment
Therapeutic Helpfulness Questionnaire
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.
Measured: after session number 5 of the 5 daily study treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AngerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonzalez-Heydrich, Joseph, M.D.
- Collaborators
- Boston Children's Hospital, Harvard University
- Responsible party
- Sponsor
- Investigators
- Elizabeth Wharff, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377948
- Sponsor's protocol ID
- X10-06-0278
- Status last verified
- Mar 2012
- First submitted
- 15 Jun 2011
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16228146
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric Unit
- ClinicalTrials.gov ID
- NCT01377948
- Acronym / sponsor ID
- X10-06-0278
- Conditions
- Anger, Aggression
- Keywords
- Anger, Aggression, CBT, Videogame, biofeedback
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gonzalez-Heydrich, Joseph, M.D.
- Collaborators
- Boston Children's Hospital, Harvard University
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT with RAGE-Control | Other | Behavioral: ACT with RAGE-Controlall 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT with RAGE-ControlAlso: Cognitive Behavioral Therapy (CBT)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. | Behavioural | ACT with RAGE-Control |
Primary outcome
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
2 secondary outcomes
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
Therapeutic Helpfulness Questionnaire
Time frame: after session number 5 of the 5 daily study treatment sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
- Background: PubMed 16228146Sukhodolsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Wharff, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Anger and Aggression, run by Gonzalez-Heydrich, Joseph, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01377948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.