Response Inhibition Training for Children With Williams Syndrome

Williams Syndrome Clinical Trial

— WSRIT  

Official title:

Developing Treatments to Improve Psychosocial Functioning in Children With Williams Syndrome Part 1: Response Inhibition Training for Children With Williams Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212314
• Other study ID #: 14.351
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: May 30, 2017
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Williams Syndrome

Intervention

Behavioral:
• Response Inhibition Training
Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.

Locations

Country	Name	City	State
United States	University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Acceptability Questionnaire	Questionnaire about study acceptability will be administered at post test after the 5-7 week training.	5-7 weeks
Other	Treatment Evaluation Inventory	Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.	5-7 weeks
Primary	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.	5-7 weeks and 3 months
Secondary	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.	5-7 weeks and 3 months
Secondary	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.	5-7 weeks and 3 months
Secondary	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.	5-7 weeks and 3 months
Secondary	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.	5-7 weeks and 3 months
Secondary	Spence Children's Anxiety Scale	The SCAS will be administered to parents at post-intervention and follow-up to assess changes in child anxieties.	5-7 weeks, 3 months
Secondary	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.	5-7 weeks and 3 months