<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/NCT03282500</url>
  </required_header>
  <id_info>
    <org_study_id>R-858-14</org_study_id>
    <nct_id>NCT03282500</nct_id>
  </id_info>
  <brief_title>Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.</brief_title>
  <official_title>Advances in Treatment: Examining the Effectiveness of a Behavioral Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kessler Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to investigate the influence a mindfulness based cognitive&#xD;
      therapy (MBCT) intervention will have on internalizing and externalizing problems in children&#xD;
      and adolescents that have suffered a Traumatic Brain Injury (TBI). MBCT is a manualized&#xD;
      intervention developed to increase social-emotional resiliency through mindful attention.&#xD;
      Internalizing problems refer to a set of symptoms in which a person over-controls their&#xD;
      emotions and results in social withdrawal, feelings of worthlessness, depression, and anxiety&#xD;
      (Bloom et al., 2001). In contrast, externalizing problems refer to an under-control of&#xD;
      emotions which results in conduct problems, impulsive behavior, and aggression. Social and&#xD;
      emotional difficulties are prominent consequences of childhood TBI. Left untreated or&#xD;
      undertreated, these problems often persist into adulthood, producing a wide range of&#xD;
      challenges adapting in personal and vocational domains. At present, there are minimal&#xD;
      non-pharmacological therapeutic approaches that effectively treat psychosocial deficits&#xD;
      unique to TBI. Developing innovative, evidence based methods is essential in helping children&#xD;
      recover from the injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic Brain Injury (TBI) represents a significant, adverse life event. Among the&#xD;
      estimated 634,000 pediatric TBI cases occurring annually in the United States (Langlois,&#xD;
      Rutlan-Brown, &amp; Thomas, 2006), some reports suggest that approximately 50% of these children&#xD;
      and adolescents will develop emotional and behavioral problems. For example, pediatric TBI is&#xD;
      associated with negative psychosocial health outcomes including symptoms of internalizing&#xD;
      such as depression, (Bloom et al., 2001; Fann, Hart, &amp; Schomer, 2009), withdrawal, and&#xD;
      anxiety, and symptoms of externalizing such as impulsivity and aggression (Iversion, 2005;&#xD;
      Cole et al., 2008). These maladaptive symptoms are typically correlated with problems in&#xD;
      interpersonal relationships and overall social adjustment, contributing to further detriment&#xD;
      to social and emotional development (Ganesalingam et al., 2011).&#xD;
&#xD;
      Despite these statistics, our understanding of how to best treat problematic psychosocial&#xD;
      sequelae that follow pediatric TBI is largely uncertain and remains an understudied area in&#xD;
      the literature. Indeed, relatively few empirically rigorous studies have been conducted&#xD;
      examining effective treatment methods targeting internalizing and externalizing symptoms&#xD;
      among youth with a TBI; yet, this is an essential area of study that needs to be a priority&#xD;
      in research efforts (Semrud-Clikeman, 2010).&#xD;
&#xD;
      Given the beneficial outcomes found with other pediatric populations, it is expected that the&#xD;
      MBCT intervention would have a similar, positive impact on adjustment among children and&#xD;
      adolescents post TBI. Problems in impulsivity, emotional lability, and anxiety are&#xD;
      experienced by many children and adolescents with a TBI, suggesting that a MBCT intervention,&#xD;
      which focuses on improving attention, regulatory processes, and reducing stress, would be&#xD;
      particularly advantageous for this population.&#xD;
&#xD;
      Youth that meet the inclusion / exclusion criteria will be randomly assigned to either the&#xD;
      control group (arts and crafts activities group) or the MBCT experimental condition. The&#xD;
      treatments will be 75 minute, weekly sessions for 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>
    <intervention_model_description>Participants are randomly assigned to either the experimental condition or the active control condition.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The participants and outcomes assessor are blind to the assigned condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Internalizing Symptoms</measure>
    <time_frame>8 weeks</time_frame>
    <description>We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Internalizing symptoms (i.e., over-controlling emotions resulting in symptoms of depression and anxiety).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Externalizing Symptoms</measure>
    <time_frame>8 weeks</time_frame>
    <description>We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Externalizing symptoms (i.e., under-controlling emotions resulting in symptoms of impulsivity, hyperactivity, and aggression).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adaptive Functioning</measure>
    <time_frame>8 weeks</time_frame>
    <description>We will examine the extent to which participants that have completed the experimental condition demonstrate an increase in adaptive functioning (i.e., resilience, social skills, leadership, activities of daily living, and functional communication).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attention</measure>
    <time_frame>8 weeks</time_frame>
    <description>We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in attention problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Psychosocial Problems</condition>
  <arm_group>
    <arm_group_label>Mindfulness Based Cognitive Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation on brain injury and treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Based Cognitive Therapy</intervention_name>
    <description>The Mindfulness Based Cognitive Therapy (MBCT) intervention promotes self-regulation of emotions and behaviors within an accepting and non-judgmental therapeutic environment. During this interactive, multisensory program, participants will learn strategies to help manage their emotions and thoughts and help them to develop greater insight into the influence these experiences have on their behaviors. Participants will engage in brief at home exercises to enhance their learning of these new skills.</description>
    <arm_group_label>Mindfulness Based Cognitive Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate or severe Traumatic Brain Injury (TBI)&#xD;
&#xD;
          -  TBI occurred at least 6 months prior&#xD;
&#xD;
          -  Age at enrollment: 9 to 17 years.&#xD;
&#xD;
          -  Elevated internalizing or externalizing symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substantial impairment in language ability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cherylynn Marino, Ph.D.</last_name>
    <phone>(973) 324-8431</phone>
    <email>cmarino@kesslerfoundation.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kessler Foundation</name>
      <address>
        <city>East Hanover</city>
        <state>New Jersey</state>
        <zip>07936</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cherylynn Marino, Ph.D.</last_name>
      <phone>973-324-8431</phone>
      <email>cmarino@kesslerfoundation.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bloom DR, Levin HS, Ewing-Cobbs L, Saunders AE, Song J, Fletcher JM, Kowatch RA. Lifetime and novel psychiatric disorders after pediatric traumatic brain injury. J Am Acad Child Adolesc Psychiatry. 2001 May;40(5):572-9. doi: 10.1097/00004583-200105000-00017.</citation>
    <PMID>11349702</PMID>
  </reference>
  <reference>
    <citation>Fann JR, Hart T, Schomer KG. Treatment for depression after traumatic brain injury: a systematic review. J Neurotrauma. 2009 Dec;26(12):2383-402. doi: 10.1089/neu.2009.1091.</citation>
    <PMID>19698070</PMID>
  </reference>
  <reference>
    <citation>Cole WR, Gerring JP, Gray RM, Vasa RA, Salorio CF, Grados M, Christensen JR, Slomine BS. Prevalence of aggressive behaviour after severe paediatric traumatic brain injury. Brain Inj. 2008 Nov;22(12):932-9. doi: 10.1080/02699050802454808.</citation>
    <PMID>19005885</PMID>
  </reference>
  <reference>
    <citation>Ganesalingam K, Yeates KO, Taylor HG, Walz NC, Stancin T, Wade S. Executive functions and social competence in young children 6 months following traumatic brain injury. Neuropsychology. 2011 Jul;25(4):466-76. doi: 10.1037/a0022768.</citation>
    <PMID>21463038</PMID>
  </reference>
  <reference>
    <citation>Langlois J, Rutland-Brown W, Thomas K. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2006.</citation>
  </reference>
  <reference>
    <citation>Semrud-Clikeman M. Pediatric traumatic brain injury: rehabilitation and transition to home and school. Appl Neuropsychol. 2010 Apr;17(2):116-22. doi: 10.1080/09084281003708985.</citation>
    <PMID>20467952</PMID>
  </reference>
  <reference>
    <citation>Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. doi: 10.1097/01.yco.0000165601.29047.ae.</citation>
    <PMID>16639155</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03282500
org study id: R-858-14
nct id: NCT03282500
lead sponsor: 
has dmc: No
The purpose of this research is to investigate the influence a mindfulness based cognitive
      therapy (MBCT) intervention will have on internalizing and externalizing problems in children
      and adolescents that have suffered a Traumatic Brain Injury (TBI). MBCT is a manualized
      intervention developed to increase social-emotional resiliency through mindful attention.
      Internalizing problems refer to a set of symptoms in which a person over-controls their
      emotions and results in social withdrawal, feelings of worthlessness, depression, and anxiety
      (Bloom et al., 2001). In contrast, externalizing problems refer to an under-control of
      emotions which results in conduct problems, impulsive behavior, and aggression. Social and
      emotional difficulties are prominent consequences of childhood TBI. Left untreated or
      undertreated, these problems often persist into adulthood, producing a wide range of
      challenges adapting in personal and vocational domains. At present, there are minimal
      non-pharmacological therapeutic approaches that effectively treat psychosocial deficits
      unique to TBI. Developing innovative, evidence based methods is essential in helping children
      recover from the injury.
Traumatic Brain Injury (TBI) represents a significant, adverse life event. Among the
      estimated 634,000 pediatric TBI cases occurring annually in the United States (Langlois,
      Rutlan-Brown, & Thomas, 2006), some reports suggest that approximately 50% of these children
      and adolescents will develop emotional and behavioral problems. For example, pediatric TBI is
      associated with negative psychosocial health outcomes including symptoms of internalizing
      such as depression, (Bloom et al., 2001; Fann, Hart, & Schomer, 2009), withdrawal, and
      anxiety, and symptoms of externalizing such as impulsivity and aggression (Iversion, 2005;
      Cole et al., 2008). These maladaptive symptoms are typically correlated with problems in
      interpersonal relationships and overall social adjustment, contributing to further detriment
      to social and emotional development (Ganesalingam et al., 2011).

      Despite these statistics, our understanding of how to best treat problematic psychosocial
      sequelae that follow pediatric TBI is largely uncertain and remains an understudied area in
      the literature. Indeed, relatively few empirically rigorous studies have been conducted
      examining effective treatment methods targeting internalizing and externalizing symptoms
      among youth with a TBI; yet, this is an essential area of study that needs to be a priority
      in research efforts (Semrud-Clikeman, 2010).

      Given the beneficial outcomes found with other pediatric populations, it is expected that the
      MBCT intervention would have a similar, positive impact on adjustment among children and
      adolescents post TBI. Problems in impulsivity, emotional lability, and anxiety are
      experienced by many children and adolescents with a TBI, suggesting that a MBCT intervention,
      which focuses on improving attention, regulatory processes, and reducing stress, would be
      particularly advantageous for this population.

      Youth that meet the inclusion / exclusion criteria will be randomly assigned to either the
      control group (arts and crafts activities group) or the MBCT experimental condition. The
      treatments will be 75 minute, weekly sessions for 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to either the experimental condition or the active control condition.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The participants and outcomes assessor are blind to the assigned condition.
measure: Internalizing Symptoms
time frame: 8 weeks
description: We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Internalizing symptoms (i.e., over-controlling emotions resulting in symptoms of depression and anxiety).
measure: Externalizing Symptoms
time frame: 8 weeks
description: We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Externalizing symptoms (i.e., under-controlling emotions resulting in symptoms of impulsivity, hyperactivity, and aggression).
measure: Adaptive Functioning
time frame: 8 weeks
description: We will examine the extent to which participants that have completed the experimental condition demonstrate an increase in adaptive functioning (i.e., resilience, social skills, leadership, activities of daily living, and functional communication).
measure: Attention
time frame: 8 weeks
description: We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in attention problems.
arm group label: Mindfulness Based Cognitive Therapy
arm group type: Experimental
description: In the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy.
arm group label: Psychoeducation on brain injury and treatment
arm group type: No Intervention
description: In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support.
intervention type: Behavioral
intervention name: Mindfulness Based Cognitive Therapy
description: The Mindfulness Based Cognitive Therapy (MBCT) intervention promotes self-regulation of emotions and behaviors within an accepting and non-judgmental therapeutic environment. During this interactive, multisensory program, participants will learn strategies to help manage their emotions and thoughts and help them to develop greater insight into the influence these experiences have on their behaviors. Participants will engage in brief at home exercises to enhance their learning of these new skills.
arm group label: Mindfulness Based Cognitive Therapy
criteria: 
gender: All
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: No
last name: Cherylynn Marino, Ph.D.
phone: (973) 324-8431
email: cmarino@kesslerfoundation.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Bloom DR, Levin HS, Ewing-Cobbs L, Saunders AE, Song J, Fletcher JM, Kowatch RA. Lifetime and novel psychiatric disorders after pediatric traumatic brain injury. J Am Acad Child Adolesc Psychiatry. 2001 May;40(5):572-9. doi: 10.1097/00004583-200105000-00017.
PMID: 11349702
citation: Fann JR, Hart T, Schomer KG. Treatment for depression after traumatic brain injury: a systematic review. J Neurotrauma. 2009 Dec;26(12):2383-402. doi: 10.1089/neu.2009.1091.
PMID: 19698070
citation: Cole WR, Gerring JP, Gray RM, Vasa RA, Salorio CF, Grados M, Christensen JR, Slomine BS. Prevalence of aggressive behaviour after severe paediatric traumatic brain injury. Brain Inj. 2008 Nov;22(12):932-9. doi: 10.1080/02699050802454808.
PMID: 19005885
citation: Ganesalingam K, Yeates KO, Taylor HG, Walz NC, Stancin T, Wade S. Executive functions and social competence in young children 6 months following traumatic brain injury. Neuropsychology. 2011 Jul;25(4):466-76. doi: 10.1037/a0022768.
PMID: 21463038
citation: Langlois J, Rutland-Brown W, Thomas K. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2006.
citation: Semrud-Clikeman M. Pediatric traumatic brain injury: rehabilitation and transition to home and school. Appl Neuropsychol. 2010 Apr;17(2):116-22. doi: 10.1080/09084281003708985.
PMID: 20467952
citation: Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. doi: 10.1097/01.yco.0000165601.29047.ae.
PMID: 16639155
responsible party type: Sponsor