<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/NCT02212314</url>
  </required_header>
  <id_info>
    <org_study_id>14.351</org_study_id>
    <nct_id>NCT02212314</nct_id>
  </id_info>
  <brief_title>Response Inhibition Training for Children With Williams Syndrome</brief_title>
  <acronym>WSRIT</acronym>
  <official_title>Developing Treatments to Improve Psychosocial Functioning in Children With Williams Syndrome Part 1: Response Inhibition Training for Children With Williams Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Milwaukee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Milwaukee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a pilot study investigating the effectiveness of a&#xD;
      computerized response inhibition training program at reducing the response inhibition&#xD;
      difficulties often seen in children with Williams syndrome ages 10-17. The investigators&#xD;
      hypothesize that after completing the training program, children with Williams syndrome will&#xD;
      show improvement on computerized measures of response inhibition and on parent measures of&#xD;
      impulsivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral characteristics of individuals with Williams syndrome include eagerness to&#xD;
      approach and interact with others (including strangers), repeated questions especially about&#xD;
      upcoming events, and difficulties with attention, impulsivity, and inhibition. There is very&#xD;
      little systematic research about the kinds of interventions that are most useful for children&#xD;
      with Williams syndrome to support optimal psychosocial functioning, and of the effectiveness&#xD;
      of such interventions. We will conduct a pilot study of a potential intervention to address&#xD;
      the response inhibition difficulties associated with Williams syndrome. The investigators&#xD;
      will examine the utility of an online, web-based computerized cognitive retraining program&#xD;
      aimed at addressing impulsivity and inhibition difficulties in 20 children, ages 10-17, with&#xD;
      WS. The engaging training program has shown some utility in other populations, including&#xD;
      children with tic disorders and trichotillomania. The investigators will examine the&#xD;
      acceptability and feasibility of the treatment approach, as well as its impact on performance&#xD;
      on experimental measures of impulsivity and on everyday psychosocial functioning as rated by&#xD;
      parents; this study will consist of a small-scale pilot Randomized Clinical Trial with wait&#xD;
      list. Through this novel work, we hope to develop and tune this approach for optimal outcomes&#xD;
      and to demonstrate the promise of this intervention to address common challenges of people&#xD;
      with Williams syndrome in the area of inhibition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Inhibition Tasks</measure>
    <time_frame>5-7 weeks and 3 months</time_frame>
    <description>Three measures of response inhibition that were administered to children at pre-test will be administered after the 5-7-week training and again at a 3-month follow-up. Measures include computer-administered Motor Stroop task, Stop Signal task, and Go/No-Go Task.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conners-3</measure>
    <time_frame>5-7 weeks and 3 months</time_frame>
    <description>The Conners-3 will be administered to parents at post-intervention and again at follow-up to assess changes in attention and impulsivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion Regulation Checklist</measure>
    <time_frame>5-7 weeks and 3 months</time_frame>
    <description>The Emotion Regulation Checklist will be administered to parents at post-intervention and follow-up to assess changes in the child's ability to regulate emotions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Scale</measure>
    <time_frame>5-7 weeks and 3 months</time_frame>
    <description>The PANAS will be administered to parents at post-intervention and follow-up to assess changes in child positive and negative affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question-Asking Questionnaire</measure>
    <time_frame>5-7 weeks and 3 months</time_frame>
    <description>The QAQ will be administered to parents at post-intervention and follow-up to assess changes in amount and frequency of child anticipatory question asking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spence Children's Anxiety Scale</measure>
    <time_frame>5-7 weeks, 3 months</time_frame>
    <description>The SCAS will be administered to parents at post-intervention and follow-up to assess changes in child anxieties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MINI Kid 6.0 Parent Version</measure>
    <time_frame>5-7 weeks and 3 months</time_frame>
    <description>The MINI Kid 6.0 Parent will be administered to parents at post-intervention and follow-up to assess changes in those areas endorsed at pre-intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Acceptability Questionnaire</measure>
    <time_frame>5-7 weeks</time_frame>
    <description>Questionnaire about study acceptability will be administered at post test after the 5-7 week training.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Evaluation Inventory</measure>
    <time_frame>5-7 weeks</time_frame>
    <description>Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Williams Syndrome</condition>
  <arm_group>
    <arm_group_label>Response Inhibition Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group will receive immediate treatment after pre-test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Crossover</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Response Inhibition Training</intervention_name>
    <description>Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.</description>
    <arm_group_label>Response Inhibition Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Williams syndrome (diagnosed with genetic testing)&#xD;
&#xD;
          -  Ages 10-17&#xD;
&#xD;
          -  First language and main language spoken in the home is English&#xD;
&#xD;
          -  Possess computer in the home that has internet access, and a second electronic device&#xD;
             with access to Skype (e.g., smartphone, ipad, additional computer, ipod touch)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  First language and main language spoken in the home is NOT English (because study&#xD;
             measures and instructions are all in English)&#xD;
&#xD;
          -  No computer in the home with internet access (because the study is being conducted via&#xD;
             the internet)&#xD;
&#xD;
          -  Comorbid severe illnesses or major surgery within the past 6 months&#xD;
&#xD;
          -  Four or more previous sessions of inhibition training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonita P Klein-Tasman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Milwaukee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Wisconsin, Milwaukee</investigator_affiliation>
    <investigator_full_name>Bonita P Klein-Tasman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Response Inhibition, Williams Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Williams Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02212314
org study id: 14.351
nct id: NCT02212314
lead sponsor: 
has dmc: No
The investigators will conduct a pilot study investigating the effectiveness of a
      computerized response inhibition training program at reducing the response inhibition
      difficulties often seen in children with Williams syndrome ages 10-17. The investigators
      hypothesize that after completing the training program, children with Williams syndrome will
      show improvement on computerized measures of response inhibition and on parent measures of
      impulsivity.
Behavioral characteristics of individuals with Williams syndrome include eagerness to
      approach and interact with others (including strangers), repeated questions especially about
      upcoming events, and difficulties with attention, impulsivity, and inhibition. There is very
      little systematic research about the kinds of interventions that are most useful for children
      with Williams syndrome to support optimal psychosocial functioning, and of the effectiveness
      of such interventions. We will conduct a pilot study of a potential intervention to address
      the response inhibition difficulties associated with Williams syndrome. The investigators
      will examine the utility of an online, web-based computerized cognitive retraining program
      aimed at addressing impulsivity and inhibition difficulties in 20 children, ages 10-17, with
      WS. The engaging training program has shown some utility in other populations, including
      children with tic disorders and trichotillomania. The investigators will examine the
      acceptability and feasibility of the treatment approach, as well as its impact on performance
      on experimental measures of impulsivity and on everyday psychosocial functioning as rated by
      parents; this study will consist of a small-scale pilot Randomized Clinical Trial with wait
      list. Through this novel work, we hope to develop and tune this approach for optimal outcomes
      and to demonstrate the promise of this intervention to address common challenges of people
      with Williams syndrome in the area of inhibition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Cognitive Inhibition Tasks
time frame: 5-7 weeks and 3 months
description: Three measures of response inhibition that were administered to children at pre-test will be administered after the 5-7-week training and again at a 3-month follow-up. Measures include computer-administered Motor Stroop task, Stop Signal task, and Go/No-Go Task.
measure: Conners-3
time frame: 5-7 weeks and 3 months
description: The Conners-3 will be administered to parents at post-intervention and again at follow-up to assess changes in attention and impulsivity.
measure: Emotion Regulation Checklist
time frame: 5-7 weeks and 3 months
description: The Emotion Regulation Checklist will be administered to parents at post-intervention and follow-up to assess changes in the child's ability to regulate emotions.
measure: Positive and Negative Affect Scale
time frame: 5-7 weeks and 3 months
description: The PANAS will be administered to parents at post-intervention and follow-up to assess changes in child positive and negative affect.
measure: Question-Asking Questionnaire
time frame: 5-7 weeks and 3 months
description: The QAQ will be administered to parents at post-intervention and follow-up to assess changes in amount and frequency of child anticipatory question asking.
measure: Spence Children's Anxiety Scale
time frame: 5-7 weeks, 3 months
description: The SCAS will be administered to parents at post-intervention and follow-up to assess changes in child anxieties.
measure: MINI Kid 6.0 Parent Version
time frame: 5-7 weeks and 3 months
description: The MINI Kid 6.0 Parent will be administered to parents at post-intervention and follow-up to assess changes in those areas endorsed at pre-intervention.
measure: Treatment Acceptability Questionnaire
time frame: 5-7 weeks
description: Questionnaire about study acceptability will be administered at post test after the 5-7 week training.
measure: Treatment Evaluation Inventory
time frame: 5-7 weeks
description: Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.
arm group label: Response Inhibition Training
arm group type: Experimental
description: Treatment group will receive immediate treatment after pre-test.
arm group label: Waitlist Crossover
arm group type: No Intervention
description: Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed.
intervention type: Behavioral
intervention name: Response Inhibition Training
description: Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
arm group label: Response Inhibition Training
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Bonita P Klein-Tasman, Ph.D.
role: Principal Investigator
affiliation: University of Wisconsin, Milwaukee
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Wisconsin, Milwaukee
investigator full name: Bonita P Klein-Tasman
investigator title: Professor
mesh term: Williams Syndrome
mesh term: Syndrome