<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03270813</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000901</org_study_id>
    <nct_id>NCT03270813</nct_id>
  </id_info>
  <brief_title>RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play</brief_title>
  <official_title>RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Academy of Child Adolescent Psychiatry.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control&#xD;
      (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation&#xD;
      skills as an intervention for symptoms of anger and aggression in children and adolescents.&#xD;
      Half of the research participants will learn relaxation techniques and practice them using&#xD;
      the RAGE-Control videogame. The other half of the participants will learn relaxation&#xD;
      techniques and play a similar videogame without the biofeedback component. The investigators&#xD;
      hypothesize that participants in the RAGE-Control group will show a greater reduction in&#xD;
      symptoms of anger and aggression than those in the non-RAGE-Control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experiencing mild anger and aggression in frustrating situations is typical in childhood;&#xD;
      however, over time most children develop the capacity to regulate their anger in emotionally&#xD;
      provoking situations. Those who continue to struggle with emotional and behavioral regulation&#xD;
      are at heightened risk for social isolation, delinquency, substance abuse, and academic&#xD;
      problems later in life. Moreover, adults who were aggressive as children experience poor&#xD;
      physical and mental health, and may find limited career opportunities.&#xD;
&#xD;
      Although anger regulation is a common and clinically significant psychiatric concern for&#xD;
      children and adolescents, effective treatment options are limited. As a result, clinicians&#xD;
      increasingly rely on psychotropic medications to blunt anger. Psychotropic medications can&#xD;
      reduce anger and aggression in the short term, but they fail in the long-term goal of&#xD;
      teaching self-regulation, and carry the risk of serious side-effects, including obesity,&#xD;
      metabolic syndrome, and type II diabetes. However, engaging youth with anger issues in&#xD;
      therapeutic treatments can be difficult, with high rates of attrition. These difficulties&#xD;
      underline the need for innovative treatments that can effectively engage patients and enhance&#xD;
      their ability to control their emotions and behaviors.&#xD;
&#xD;
      In response to this need, clinicians at Boston Children's Hospital developed Regulate and&#xD;
      Gain Emotional Control (RAGE-Control), a therapeutic videogame that requires players to&#xD;
      maintain low levels of physiologic arousal while rapidly reacting to incoming stimuli and&#xD;
      inhibiting erroneous responses. It was initially designed for use with Cognitive Behavioral&#xD;
      Therapy (CBT) to motivate children to remain engaged in therapy, and to foster the learning,&#xD;
      practice, and generalization of self-regulation skills in the midst of frustrating or anger&#xD;
      provoking situations. Pilot data from an open label trial of RAGE-Control on a pediatric&#xD;
      psychiatric inpatient unit demonstrated improvement in patient self-reported anger and&#xD;
      aggression after 5 sessions of CBT with RAGE-Control, when compared with a treatment as usual&#xD;
      group. A subsequent outpatient randomized controlled trial comparing CBT with RAGE-Control to&#xD;
      CBT with a sham videogame demonstrated that patients who participated in the RAGE-Control&#xD;
      intervention had significantly greater improvements in overt aggression and oppositionality,&#xD;
      parental stress, and family atmosphere. The participants in the RAGE-Control group also had&#xD;
      fewer drop outs, and twice as many treatment responders as the participants in the control&#xD;
      arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Global Impressions Global Rating of Improvement (CGI-I)</measure>
    <time_frame>Up to 3 months post-intervention</time_frame>
    <description>Assesses improvement post treatment, with scores ranging from 1 (very much improved) to 7 (very much worse).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions Severity of Illness (CGI-S)</measure>
    <time_frame>Up to 3 months post intervention</time_frame>
    <description>Assess overall burden of illness on a scale from 1 (normal, not ill) to 7 (very severely ill).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)</measure>
    <time_frame>Baseline, 2 weeks post treatment, 3 months post treatment</time_frame>
    <description>35 item self-report scale that assesses state anger, trait anger and expression of anger.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Adolescent Satisfaction Scale (MASS)</measure>
    <time_frame>2 weeks post treatment, 3 months post treatment</time_frame>
    <description>Measures patient satisfaction with the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Overt Aggression Scale (MOAS)</measure>
    <time_frame>Baseline, 2 weeks post treatment, 3 months post treatment</time_frame>
    <description>Records the severity of 4 types of aggression: verbal, against property, physical, and against self.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS)</measure>
    <time_frame>Baseline, 2 weeks post treatment, 3 months post treatment</time_frame>
    <description>36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. For patients age 10 and older only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale - impulse control difficulties</measure>
    <time_frame>Up to 3 months post intervention</time_frame>
    <description>6 items of the DERS specifically designed to assess impulse control difficulties. For patients age 10 and older only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Behavior Checklist (CBCL) 6-18</measure>
    <time_frame>Baseline, 2 weeks post treatment, 3 months post treatment</time_frame>
    <description>Empirically based checklist of social competence and behavioral problems, filled out by parents based on recent behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Weekly for 6 weeks</time_frame>
    <description>The computer will record each participant's heart rate while they play the videogame.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion Regulation Checklist (ERC)</measure>
    <time_frame>Up to 3 months post intervention</time_frame>
    <description>24 item parent-report questionnaire regarding a child's ability to assess emotion regulation in the past 1 week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Anger</condition>
  <condition>Aggression</condition>
  <arm_group>
    <arm_group_label>RAGE-Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There are 6 research intervention sessions, which will involve Relaxation training plus RAGE-Control. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, introduction to the RAGE-Control videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham videogame</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>There are 6 research intervention sessions, which will involve Relaxation training plus Sham videogame. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, an introduction to the Sham videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation training plus RAGE-Control</intervention_name>
    <description>RAGE-Control is a biofeedback videogame in which players shoot at enemies while avoiding allies. The player's baseline heart rate is taken before the game and entered into the computer. During the game, the player wears a heart rate monitor, and if the player's heart rate rises above baseline, they are unable to shoot. The player must use relaxation skills to decrease their heart rate below the baseline before they can resume play. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the RAGE-Control videogame.</description>
    <arm_group_label>RAGE-Control</arm_group_label>
    <other_name>RAGE-Control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation training plus Sham Videogame</intervention_name>
    <description>The Sham videogame is a videogame in which players shoot at enemies while avoiding allies. The player wears a heart rate monitor during the game, but the heart rate does not affect the functioning of the game in any way. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the Sham videogame.</description>
    <arm_group_label>Sham videogame</arm_group_label>
    <other_name>Sham Videogame</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Problems with anger and/or aggression&#xD;
&#xD;
          -  Score of at least 4/10 on phone screen with parents measuring anger and aggression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Changes in dosing of psychotropic medications within the 8 weeks prior to the start of&#xD;
             the study, or anticipated medication changes during the study.&#xD;
&#xD;
          -  Starting therapy within the 8 weeks prior to starting the study, or anticipated new&#xD;
             therapy beginning during the study.&#xD;
&#xD;
          -  Actively participating in any type of Cognitive Behavioral Therapy for less than 12&#xD;
             weeks and/or attending Cognitive Behavioral Therapy weekly or more.&#xD;
&#xD;
          -  Intellectual disability (IQ &lt; 80)&#xD;
&#xD;
          -  Suicidal ideation&#xD;
&#xD;
          -  Homicidal ideation&#xD;
&#xD;
          -  Psychosis/meets criteria for psychotic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carrie Vaudreuil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kahn J, Ducharme P, Rotenberg A, Gonzalez-Heydrich J. &quot;RAGE-Control&quot;: A Game to Build Emotional Strength. Games Health J. 2013 Feb;2(1):53-7. doi: 10.1089/g4h.2013.0007.</citation>
    <PMID>26196556</PMID>
  </reference>
  <reference>
    <citation>Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.</citation>
    <PMID>19745492</PMID>
  </reference>
  <reference>
    <citation>Ducharme P., Wharff E., Kahn J., Hutchinson E., &amp; Logan G. Augmenting anger control therapy with a videogame requiring emotional control: A pilot study on an inpatient psychiatric unit. Adolescent Psychiatry, 2012; 2(4), 323-332.</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Carrie Vaudreuil</investigator_full_name>
    <investigator_title>Assistant in Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Child</keyword>
  <keyword>Adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 10, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03270813
org study id: 2015P000901
nct id: NCT03270813
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control
      (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation
      skills as an intervention for symptoms of anger and aggression in children and adolescents.
      Half of the research participants will learn relaxation techniques and practice them using
      the RAGE-Control videogame. The other half of the participants will learn relaxation
      techniques and play a similar videogame without the biofeedback component. The investigators
      hypothesize that participants in the RAGE-Control group will show a greater reduction in
      symptoms of anger and aggression than those in the non-RAGE-Control group.
Experiencing mild anger and aggression in frustrating situations is typical in childhood;
      however, over time most children develop the capacity to regulate their anger in emotionally
      provoking situations. Those who continue to struggle with emotional and behavioral regulation
      are at heightened risk for social isolation, delinquency, substance abuse, and academic
      problems later in life. Moreover, adults who were aggressive as children experience poor
      physical and mental health, and may find limited career opportunities.

      Although anger regulation is a common and clinically significant psychiatric concern for
      children and adolescents, effective treatment options are limited. As a result, clinicians
      increasingly rely on psychotropic medications to blunt anger. Psychotropic medications can
      reduce anger and aggression in the short term, but they fail in the long-term goal of
      teaching self-regulation, and carry the risk of serious side-effects, including obesity,
      metabolic syndrome, and type II diabetes. However, engaging youth with anger issues in
      therapeutic treatments can be difficult, with high rates of attrition. These difficulties
      underline the need for innovative treatments that can effectively engage patients and enhance
      their ability to control their emotions and behaviors.

      In response to this need, clinicians at Boston Children's Hospital developed Regulate and
      Gain Emotional Control (RAGE-Control), a therapeutic videogame that requires players to
      maintain low levels of physiologic arousal while rapidly reacting to incoming stimuli and
      inhibiting erroneous responses. It was initially designed for use with Cognitive Behavioral
      Therapy (CBT) to motivate children to remain engaged in therapy, and to foster the learning,
      practice, and generalization of self-regulation skills in the midst of frustrating or anger
      provoking situations. Pilot data from an open label trial of RAGE-Control on a pediatric
      psychiatric inpatient unit demonstrated improvement in patient self-reported anger and
      aggression after 5 sessions of CBT with RAGE-Control, when compared with a treatment as usual
      group. A subsequent outpatient randomized controlled trial comparing CBT with RAGE-Control to
      CBT with a sham videogame demonstrated that patients who participated in the RAGE-Control
      intervention had significantly greater improvements in overt aggression and oppositionality,
      parental stress, and family atmosphere. The participants in the RAGE-Control group also had
      fewer drop outs, and twice as many treatment responders as the participants in the control
      arm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Clinical Global Impressions Global Rating of Improvement (CGI-I)
time frame: Up to 3 months post-intervention
description: Assesses improvement post treatment, with scores ranging from 1 (very much improved) to 7 (very much worse).
measure: Clinical Global Impressions Severity of Illness (CGI-S)
time frame: Up to 3 months post intervention
description: Assess overall burden of illness on a scale from 1 (normal, not ill) to 7 (very severely ill).
measure: State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)
time frame: Baseline, 2 weeks post treatment, 3 months post treatment
description: 35 item self-report scale that assesses state anger, trait anger and expression of anger.
measure: Multidimensional Adolescent Satisfaction Scale (MASS)
time frame: 2 weeks post treatment, 3 months post treatment
description: Measures patient satisfaction with the intervention
measure: Modified Overt Aggression Scale (MOAS)
time frame: Baseline, 2 weeks post treatment, 3 months post treatment
description: Records the severity of 4 types of aggression: verbal, against property, physical, and against self.
measure: Difficulties in Emotion Regulation Scale (DERS)
time frame: Baseline, 2 weeks post treatment, 3 months post treatment
description: 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. For patients age 10 and older only.
measure: Difficulties in Emotion Regulation Scale - impulse control difficulties
time frame: Up to 3 months post intervention
description: 6 items of the DERS specifically designed to assess impulse control difficulties. For patients age 10 and older only.
measure: Child Behavior Checklist (CBCL) 6-18
time frame: Baseline, 2 weeks post treatment, 3 months post treatment
description: Empirically based checklist of social competence and behavioral problems, filled out by parents based on recent behavior.
measure: Heart rate
time frame: Weekly for 6 weeks
description: The computer will record each participant's heart rate while they play the videogame.
measure: Emotion Regulation Checklist (ERC)
time frame: Up to 3 months post intervention
description: 24 item parent-report questionnaire regarding a child's ability to assess emotion regulation in the past 1 week.
arm group label: RAGE-Control
arm group type: Experimental
description: There are 6 research intervention sessions, which will involve Relaxation training plus RAGE-Control. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, introduction to the RAGE-Control videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.
arm group label: Sham videogame
arm group type: Sham Comparator
description: There are 6 research intervention sessions, which will involve Relaxation training plus Sham videogame. The first session includes a 30-minute lesson on the relationship between physiological arousal and anger, an introduction to the Sham videogame and 15 minutes of videogame play. The next 5 sessions include a 10-minute check in about symptoms and functioning, a brief presentation of a relaxation skill, and 15 minutes of videogame play.
intervention type: Behavioral
intervention name: Relaxation training plus RAGE-Control
description: RAGE-Control is a biofeedback videogame in which players shoot at enemies while avoiding allies. The player's baseline heart rate is taken before the game and entered into the computer. During the game, the player wears a heart rate monitor, and if the player's heart rate rises above baseline, they are unable to shoot. The player must use relaxation skills to decrease their heart rate below the baseline before they can resume play. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the RAGE-Control videogame.
arm group label: RAGE-Control
other name: RAGE-Control
intervention type: Behavioral
intervention name: Relaxation training plus Sham Videogame
description: The Sham videogame is a videogame in which players shoot at enemies while avoiding allies. The player wears a heart rate monitor during the game, but the heart rate does not affect the functioning of the game in any way. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the Sham videogame.
arm group label: Sham videogame
other name: Sham Videogame
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Carrie Vaudreuil, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
citation: Kahn J, Ducharme P, Rotenberg A, Gonzalez-Heydrich J. "RAGE-Control": A Game to Build Emotional Strength. Games Health J. 2013 Feb;2(1):53-7. doi: 10.1089/g4h.2013.0007.
PMID: 26196556
citation: Kahn J, Ducharme P, Travers B, Gonzalez-Heydrich J. RAGE Control: Regulate and Gain Emotional Control. Stud Health Technol Inform. 2009;149:335-43.
PMID: 19745492
citation: Ducharme P., Wharff E., Kahn J., Hutchinson E., & Logan G. Augmenting anger control therapy with a videogame requiring emotional control: A pilot study on an inpatient psychiatric unit. Adolescent Psychiatry, 2012; 2(4), 323-332.
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Carrie Vaudreuil
investigator title: Assistant in Psychiatry
mesh term: Aggression
sharing ipd: Undecided
submitted: June 10, 2023