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Response Inhibition Training for Children With Williams Syndrome (WSRIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212314
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Bonita P Klein-Tasman, University of Wisconsin, Milwaukee

Tracking Information
First Submitted Date  ICMJE August 6, 2014
First Posted Date  ICMJE August 8, 2014
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Cognitive Inhibition Tasks [ Time Frame: 5-7 weeks and 3 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • Conners-3 [ Time Frame: 5-7 weeks and 3 months ]
    The Conners-3 will be administered to parents at post-intervention and again at follow-up to assess changes in attention and impulsivity.
  • Emotion Regulation Checklist [ Time Frame: 5-7 weeks and 3 months ]
    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.
  • Positive and Negative Affect Scale [ Time Frame: 5-7 weeks and 3 months ]
    The PANAS will be administered to parents at post-intervention and follow-up to assess changes in child positive and negative affect.
  • Question-Asking Questionnaire [ Time Frame: 5-7 weeks and 3 months ]
    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.
  • Spence Children's Anxiety Scale [ Time Frame: 5-7 weeks, 3 months ]
    The SCAS will be administered to parents at post-intervention and follow-up to assess changes in child anxieties.
  • MINI Kid 6.0 Parent Version [ Time Frame: 5-7 weeks and 3 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2014)
  • Treatment Acceptability Questionnaire [ Time Frame: 5-7 weeks ]
    Questionnaire about study acceptability will be administered at post test after the 5-7 week training.
  • Treatment Evaluation Inventory [ Time Frame: 5-7 weeks ]
    Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Response Inhibition Training for Children With Williams Syndrome
Official Title  ICMJE Developing Treatments to Improve Psychosocial Functioning in Children With Williams Syndrome Part 1: Response Inhibition Training for Children With Williams Syndrome
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Williams Syndrome
Intervention  ICMJE Behavioral: Response Inhibition Training
Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
Study Arms  ICMJE
  • Experimental: Response Inhibition Training
    Treatment group will receive immediate treatment after pre-test.
    Intervention: Behavioral: Response Inhibition Training
  • No Intervention: Waitlist Crossover
    Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
20
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Williams syndrome (diagnosed with genetic testing)
  • Ages 10-17
  • First language and main language spoken in the home is English
  • Possess computer in the home that has internet access, and a second electronic device with access to Skype (e.g., smartphone, ipad, additional computer, ipod touch)

Exclusion Criteria:

  • First language and main language spoken in the home is NOT English (because study measures and instructions are all in English)
  • No computer in the home with internet access (because the study is being conducted via the internet)
  • Comorbid severe illnesses or major surgery within the past 6 months
  • Four or more previous sessions of inhibition training
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02212314
Other Study ID Numbers  ICMJE 14.351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bonita P Klein-Tasman, University of Wisconsin, Milwaukee
Study Sponsor  ICMJE University of Wisconsin, Milwaukee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bonita P Klein-Tasman, Ph.D. University of Wisconsin, Milwaukee
PRS Account University of Wisconsin, Milwaukee
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP