<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/NCT03284060</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A00881-52</org_study_id>
    <nct_id>NCT03284060</nct_id>
  </id_info>
  <brief_title>Social Cognition Training and Cognitive Remediation</brief_title>
  <acronym>RCKID</acronym>
  <official_title>Social Cognition Training and Cognitive Remediation : a New Tool for 22q11.2 Deletion Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital le Vinatier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital le Vinatier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Social cognition refers to mental operations that enable people to perceive, interpret&#xD;
      constantly changing social informations. These processes allow people to rapidly,&#xD;
      effortlessly and flexibly perceive and interpret rapidly-changing social information, and&#xD;
      respond appropriately to social stimuli. Besides, this ability gives meaning to the actions&#xD;
      of others. Impairments in this field may largely underlie social dysfunctions and reduce&#xD;
      adaptive skills. Moreover, social cognitive disabilities contribute more or less directly to&#xD;
      behavioral disturbances and psychiatric symptoms The &quot;RC KID&quot; program involves a variety of&#xD;
      exercises in a paper and/or pencil or a computerized format or role playing and a strategy&#xD;
      coaching approach. &quot;RC KID&quot; targets the emotion recognition and social interaction.&#xD;
&#xD;
      A little cartoon character (a pirate), is supposed to be very friendly and kind toward&#xD;
      children. The pirate will accompany them throughout the program for an effective and positive&#xD;
      reinforcement. The main goal of &quot;RC KID&quot; is to adjust to children's difficulties in daily&#xD;
      life.&#xD;
&#xD;
      Moreover, since the cognitive remediation benefit is complex to apply in daily life, the&#xD;
      program is based on a metacognitive strategy.&#xD;
&#xD;
      After a complete neuropsychological assessment and a psychoeducational session (with the&#xD;
      child and the parents), 16 1-h-sessions of cognitive remediation with the therapist are&#xD;
      proposed. Each session is composed of three parts: (1) computerized tasks focusing on&#xD;
      specific emotion recognition components (20 min). RC KID is composed of 2 modules : Emotion&#xD;
      recognition and social interaction. These tasks contain photo or video. (2) pen and paper or&#xD;
      role playing tasks focusing on the same processes (20 min) (3) a proposal of a home-based&#xD;
      task (during 20 min). Weekly, home tasks are proposed to the child and analyzed with the&#xD;
      parents and the therapist. Indeed, home exercises are useful to promote the transfer of&#xD;
      strategies to daily life and their subsequent automation. The heterogeneity of cognitive&#xD;
      deficits in 22q11.2 deletion necessitates an individualized cognitive remediation therapy. In&#xD;
      this regard, &quot;RC KID&quot; seems to be a promising tool.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The second objective is to evaluate the impact of RC KID on behavior disorders. Method : a&#xD;
      validation study using multiple single-case experimental designs. A thorough assessment,&#xD;
      including a complete evaluation of components of social cognition but also clinical and&#xD;
      neuropsychological assessments is proposed for each patient enrolled in the study.&#xD;
&#xD;
      Investigators collect three kinds of baselines before the beginning of the cognitive&#xD;
      remediation intervention: baselines specific of the targeted component (Emotion recognition&#xD;
      and Theory of Mind), non-specific baselines (such as measures of neurocognition processes&#xD;
      that should not be affected by the intervention), and intermediary baselines that is measures&#xD;
      of social cognitive function linked with targeted processes but not directly concerned by the&#xD;
      cognitive remediation program.&#xD;
&#xD;
      These measures and the complete assessment will be repeated at the end of the intervention to&#xD;
      highlight impacts of RC KID on social cognitive impairments, and 6 months later to&#xD;
      investigate the possible long-lasting effects of the benefits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    inclusion difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">May 21, 2019</completion_date>
  <primary_completion_date type="Actual">March 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>open Label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is the variation in sub-scores of specific baselines, obtained before and after cognitive remediation intervention:</measure>
    <time_frame>6 months</time_frame>
    <description>baselines specific of the targeted component (Emotion recognition and Theory of Mind), non-specific baselines (such as measures of neurocognition processes that should not be affected by the intervention), intermediary baselines that is measures of social cognitive function linked with targeted processes but not directly concerned by the cognitive remediation program.&#xD;
These measure is repeated at the end of the intervention to highlight the impact of the &quot; RCKID &quot; program, and 6 months later to investigate the possible long-lasting effects of the benefits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aberrant Behavior Checklist scale</measure>
    <time_frame>6 months</time_frame>
    <description>Change in sub-score &quot; hyperactivity / non compliance &quot; (scale &quot; Aberrant Behavior Checklist &quot;) (completed by parents or the educational team). This measure is repeated at the end of the intervention to highlight the impact of the &quot; RC KID &quot; program, and 6 months later to investigate the possible long-lasting effects of the benefits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MDI-C scale ( Multiscore Depression Inventory for Children scale)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KIDSCREEN-27 scale</measure>
    <time_frame>6 months</time_frame>
    <description>The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy &amp; Parents (7 items), Peers &amp; Social Support (4 items), and School Environment (4 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vineland 2 scale (Vineland Adaptive Behavior Scale)</measure>
    <time_frame>6 months</time_frame>
    <description>A measure of adaptive behavior from birth to adulthood</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>22q11.2 Deletion Syndrome</condition>
  <arm_group>
    <arm_group_label>Cognitive remediation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive remediation program</intervention_name>
    <description>Cognitive remediation program is a set of reeducation techniques and aims at restoring or compensating altered cognitive functions such as memory, attentional or executive functions, and social cognition. Therapists help individuals develop new information processing strategies designed to meet their needs and wishes. Specific therapeutic sessions are designed to generalize such strategies to everyday situations to reduce the impact of cognitive deficits on daily life. Thus, social cognitive training therapy helps the development of personal strategies specifically adapted to preserve skills and reduce the difficulties.&#xD;
16 sessions (45 min) of cognitive remediation with the therapist are proposed, each session is composed of three parts:&#xD;
pen and paper tasks focusing on specific emotion recognition component (20 min),&#xD;
computerized tasks focusing on the same process (20 min),&#xD;
a proposal of a home-based task (during 20 min).</description>
    <arm_group_label>Cognitive remediation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with diagnosis of 22q11.2 deletion syndrome (CGH-Array and FISH)&#xD;
&#xD;
          -  Native French speaker&#xD;
&#xD;
          -  Clinically stable&#xD;
&#xD;
          -  Parental and children consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of neurological illness or trauma&#xD;
&#xD;
          -  Taking of medicine with somatic aim having a cerebral or psychic impact&#xD;
&#xD;
          -  Simultaneous participation on another program of cognitive remediation&#xD;
&#xD;
          -  child or parents unlikely to cooperate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DEMILY CAROLINE, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier le Vinatier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Vinatier</name>
      <address>
        <city>Lyon</city>
        <state>Rhone Alpes</state>
        <zip>69678</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive remediation, 22q11.2 deletion syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>DiGeorge Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03284060
org study id: 2017-A00881-52
nct id: NCT03284060
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Social cognition refers to mental operations that enable people to perceive, interpret
      constantly changing social informations. These processes allow people to rapidly,
      effortlessly and flexibly perceive and interpret rapidly-changing social information, and
      respond appropriately to social stimuli. Besides, this ability gives meaning to the actions
      of others. Impairments in this field may largely underlie social dysfunctions and reduce
      adaptive skills. Moreover, social cognitive disabilities contribute more or less directly to
      behavioral disturbances and psychiatric symptoms The "RC KID" program involves a variety of
      exercises in a paper and/or pencil or a computerized format or role playing and a strategy
      coaching approach. "RC KID" targets the emotion recognition and social interaction.

      A little cartoon character (a pirate), is supposed to be very friendly and kind toward
      children. The pirate will accompany them throughout the program for an effective and positive
      reinforcement. The main goal of "RC KID" is to adjust to children's difficulties in daily
      life.

      Moreover, since the cognitive remediation benefit is complex to apply in daily life, the
      program is based on a metacognitive strategy.

      After a complete neuropsychological assessment and a psychoeducational session (with the
      child and the parents), 16 1-h-sessions of cognitive remediation with the therapist are
      proposed. Each session is composed of three parts: (1) computerized tasks focusing on
      specific emotion recognition components (20 min). RC KID is composed of 2 modules : Emotion
      recognition and social interaction. These tasks contain photo or video. (2) pen and paper or
      role playing tasks focusing on the same processes (20 min) (3) a proposal of a home-based
      task (during 20 min). Weekly, home tasks are proposed to the child and analyzed with the
      parents and the therapist. Indeed, home exercises are useful to promote the transfer of
      strategies to daily life and their subsequent automation. The heterogeneity of cognitive
      deficits in 22q11.2 deletion necessitates an individualized cognitive remediation therapy. In
      this regard, "RC KID" seems to be a promising tool.
The second objective is to evaluate the impact of RC KID on behavior disorders. Method : a
      validation study using multiple single-case experimental designs. A thorough assessment,
      including a complete evaluation of components of social cognition but also clinical and
      neuropsychological assessments is proposed for each patient enrolled in the study.

      Investigators collect three kinds of baselines before the beginning of the cognitive
      remediation intervention: baselines specific of the targeted component (Emotion recognition
      and Theory of Mind), non-specific baselines (such as measures of neurocognition processes
      that should not be affected by the intervention), and intermediary baselines that is measures
      of social cognitive function linked with targeted processes but not directly concerned by the
      cognitive remediation program.

      These measures and the complete assessment will be repeated at the end of the intervention to
      highlight impacts of RC KID on social cognitive impairments, and 6 months later to
      investigate the possible long-lasting effects of the benefits.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open Label
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint is the variation in sub-scores of specific baselines, obtained before and after cognitive remediation intervention:
time frame: 6 months
description: baselines specific of the targeted component (Emotion recognition and Theory of Mind), non-specific baselines (such as measures of neurocognition processes that should not be affected by the intervention), intermediary baselines that is measures of social cognitive function linked with targeted processes but not directly concerned by the cognitive remediation program.
These measure is repeated at the end of the intervention to highlight the impact of the " RCKID " program, and 6 months later to investigate the possible long-lasting effects of the benefits
measure: Aberrant Behavior Checklist scale
time frame: 6 months
description: Change in sub-score " hyperactivity / non compliance " (scale " Aberrant Behavior Checklist ") (completed by parents or the educational team). This measure is repeated at the end of the intervention to highlight the impact of the " RC KID " program, and 6 months later to investigate the possible long-lasting effects of the benefits.
measure: MDI-C scale ( Multiscore Depression Inventory for Children scale)
time frame: 6 months
measure: KIDSCREEN-27 scale
time frame: 6 months
description: The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items).
measure: Vineland 2 scale (Vineland Adaptive Behavior Scale)
time frame: 6 months
description: A measure of adaptive behavior from birth to adulthood
arm group label: Cognitive remediation program
arm group type: Experimental
intervention type: Behavioral
intervention name: Cognitive remediation program
description: Cognitive remediation program is a set of reeducation techniques and aims at restoring or compensating altered cognitive functions such as memory, attentional or executive functions, and social cognition. Therapists help individuals develop new information processing strategies designed to meet their needs and wishes. Specific therapeutic sessions are designed to generalize such strategies to everyday situations to reduce the impact of cognitive deficits on daily life. Thus, social cognitive training therapy helps the development of personal strategies specifically adapted to preserve skills and reduce the difficulties.
16 sessions (45 min) of cognitive remediation with the therapist are proposed, each session is composed of three parts:
pen and paper tasks focusing on specific emotion recognition component (20 min),
computerized tasks focusing on the same process (20 min),
a proposal of a home-based task (during 20 min).
arm group label: Cognitive remediation program
criteria: 
gender: All
minimum age: 5 Years
maximum age: 13 Years
healthy volunteers: No
last name: DEMILY CAROLINE, PH
role: Principal Investigator
affiliation: Centre Hospitalier le Vinatier
facility: 
country: France
responsible party type: Sponsor
mesh term: DiGeorge Syndrome
mesh term: Syndrome
sharing ipd: No