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Response Inhibition Training for Children With Williams Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02212314
Acronym
WSRIT
Enrollment
25
Registered
2014-08-08
Start date
2014-05-31
Completion date
2016-05-31
Last updated
2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Williams Syndrome

Keywords

Response Inhibition, 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.

Interventions

Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.

Sponsors

University of Wisconsin, Milwaukee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive Inhibition Tasks5-7 weeks and 3 monthsThree 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

MeasureTime frameDescription
Conners-35-7 weeks and 3 monthsThe Conners-3 will be administered to parents at post-intervention and again at follow-up to assess changes in attention and impulsivity.
Emotion Regulation Checklist5-7 weeks and 3 monthsThe 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 Scale5-7 weeks and 3 monthsThe PANAS will be administered to parents at post-intervention and follow-up to assess changes in child positive and negative affect.
Spence Children's Anxiety Scale5-7 weeks, 3 monthsThe SCAS will be administered to parents at post-intervention and follow-up to assess changes in child anxieties.
MINI Kid 6.0 Parent Version5-7 weeks and 3 monthsThe 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.
Question-Asking Questionnaire5-7 weeks and 3 monthsThe QAQ will be administered to parents at post-intervention and follow-up to assess changes in amount and frequency of child anticipatory question asking.

Other

MeasureTime frameDescription
Treatment Acceptability Questionnaire5-7 weeksQuestionnaire about study acceptability will be administered at post test after the 5-7 week training.
Treatment Evaluation Inventory5-7 weeksQuestionnaire evaluating treatment will be administered at post test after the 5-7 week training.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026