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Completed

NCT Number: NCT02212314

Response Inhibition Training for Children With Williams Syndrome

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.

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Key information

Conditions

Williams Syndrome Aortic Stenosis, Supravalvular Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab

Milwaukee, Wisconsin, 53211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Response inhibition training

Behavioral

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

Primary outcomes

  1. Cognitive Inhibition Tasks

    Time frame: 5-7 weeks and 3 months

    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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. Treatment Acceptability Questionnaire

    Time frame: 5-7 weeks

    Questionnaire about study acceptability will be administered at post test after the 5-7 week training.

  2. Treatment Evaluation Inventory

    Time frame: 5-7 weeks

    Questionnaire evaluating treatment will be administered at post test after the 5-7 week training.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Registry information

Official study title

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

Acronym: WSRIT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2014
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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