Clinical Trial: Response Inhibition Training for Children With Williams Syndrome

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: University of Wisconsin, Milwaukee

Current Primary Outcome: Cognitive Inhibition Tasks [ Time Frame: 5-7 weeks and 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: University of Wisconsin, Milwaukee

Dates:
Date Received: August 6, 2014
Date Started: May 2014
Date Completion: December 2015
Last Updated: May 26, 2015
Last Verified: May 2015