Response Inhibition Training for Children With Williams Syndrome (WSRIT)
Primary Purpose
Williams Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Response Inhibition Training
Sponsored by
About this trial
This is an interventional treatment trial for Williams Syndrome focused on measuring Response Inhibition, Williams Syndrome
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Response Inhibition Training
Waitlist Crossover
Arm Description
Treatment group will receive immediate treatment after pre-test.
Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed.
Outcomes
Primary Outcome Measures
Cognitive Inhibition Tasks
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.
Secondary Outcome Measures
Conners-3
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
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
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
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
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
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.
Full Information
NCT ID
NCT02212314
First Posted
August 6, 2014
Last Updated
May 30, 2017
Sponsor
University of Wisconsin, Milwaukee
1. Study Identification
Unique Protocol Identification Number
NCT02212314
Brief Title
Response Inhibition Training for Children With Williams Syndrome
Acronym
WSRIT
Official Title
Developing Treatments to Improve Psychosocial Functioning in Children With Williams Syndrome Part 1: Response Inhibition Training for Children With Williams Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Williams Syndrome
Keywords
Response Inhibition, Williams Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Response Inhibition Training
Arm Type
Experimental
Arm Description
Treatment group will receive immediate treatment after pre-test.
Arm Title
Waitlist Crossover
Arm Type
No Intervention
Arm 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(s)
Response Inhibition Training
Intervention Description
Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
Primary Outcome Measure Information:
Title
Cognitive Inhibition Tasks
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.
Time Frame
5-7 weeks and 3 months
Secondary Outcome Measure Information:
Title
Conners-3
Description
The Conners-3 will be administered to parents at post-intervention and again at follow-up to assess changes in attention and impulsivity.
Time Frame
5-7 weeks and 3 months
Title
Emotion Regulation Checklist
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.
Time Frame
5-7 weeks and 3 months
Title
Positive and Negative Affect Scale
Description
The PANAS will be administered to parents at post-intervention and follow-up to assess changes in child positive and negative affect.
Time Frame
5-7 weeks and 3 months
Title
Question-Asking Questionnaire
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.
Time Frame
5-7 weeks and 3 months
Title
Spence Children's Anxiety Scale
Description
The SCAS will be administered to parents at post-intervention and follow-up to assess changes in child anxieties.
Time Frame
5-7 weeks, 3 months
Title
MINI Kid 6.0 Parent Version
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.
Time Frame
5-7 weeks and 3 months
Other Pre-specified Outcome Measures:
Title
Treatment Acceptability Questionnaire
Description
Questionnaire about study acceptability will be administered at post test after the 5-7 week training.
Time Frame
5-7 weeks
Title
Treatment Evaluation Inventory
Description
Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.
Time Frame
5-7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonita P Klein-Tasman, Ph.D.
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Response Inhibition Training for Children With Williams Syndrome
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