An interventional study of Response Inhibition Training in Williams Syndrome, sponsored by University of Wisconsin, Milwaukee. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-05-31.
Sponsored by University of Wisconsin, Milwaukee · Not applicable, Interventional, and Treatment
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.
29 studies on the registry are indexed under Williams Syndrome; 11 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 12 interventional studies indexed under Williams Syndrome.
Browse Williams Syndrome studies →University of Wisconsin, Milwaukee is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment group will receive immediate treatment after pre-test.
Behavioral: Response Inhibition Training
Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed.
Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
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.
Time frame: 5-7 weeks and 3 months
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.
Time frame: 5-7 weeks and 3 months
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.
Time frame: 5-7 weeks and 3 months
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.
Time frame: 5-7 weeks and 3 months
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.
Time frame: 5-7 weeks and 3 months
Spence Children's Anxiety Scale
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
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.
Time frame: 5-7 weeks and 3 months
Treatment Acceptability Questionnaire
Questionnaire about study acceptability will be administered at post test after the 5-7 week training.
Time frame: 5-7 weeks
Treatment Evaluation Inventory
Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.
Time frame: 5-7 weeks
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Milwaukee