Williams SyndromeWSRITNCT02212314
Response Inhibition Training for Children With Williams Syndrome
A study testing Response Inhibition Training in people with Williams Syndrome, run by University of Wisconsin, Milwaukee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Williams Syndrome
- What is being tested?
- Response Inhibition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab
Milwaukee, Wisconsin, 53211
About this study
Official title: Developing Treatments to Improve Psychosocial Functioning in Children With Williams Syndrome Part 1: 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.
Read the 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.
- Conditions
- Williams Syndrome
- Being tested
- Response Inhibition Training
- Keywords
- Response Inhibition, Williams Syndrome
- Medical subject headings
- Williams Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response Inhibition TrainingBehavioural
Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Response Inhibition Training | Experimental | Treatment group will receive immediate treatment after pre-test. Receives: Behavioral: Response Inhibition Training |
| Waitlist Crossover | No intervention | Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-7 weeks and 3 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5-7 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Williams SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonita P Klein-Tasman, University of Wisconsin, Milwaukee
- Investigators
- Bonita P Klein-Tasman, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212314
- Sponsor's protocol ID
- 14.351
- Acronym
- WSRIT
- Status last verified
- May 2017
- First submitted
- 6 Aug 2014
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Treatments to Improve Psychosocial Functioning in Children With Williams Syndrome Part 1: Response Inhibition Training for Children With Williams Syndrome
- ClinicalTrials.gov ID
- NCT02212314
- Acronym / sponsor ID
- WSRIT / 14.351
- Conditions
- Williams Syndrome
- Keywords
- Response Inhibition, Williams Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Response Inhibition Training | Experimental | Behavioral: Response Inhibition TrainingTreatment group will receive immediate treatment after pre-test. |
| Waitlist Crossover | No intervention | –Waitlist group will not receive intervention while treatment group is active, but waitlist group will be offered treatment after post-test is completed. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response Inhibition TrainingComputerized response inhibition training will be delivered via the Internet for 10 individual sessions. | Behavioural | Response Inhibition Training |
Primary outcome
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.
6 secondary outcomes
Conners-3
Time frame: 5-7 weeks and 3 months
Emotion Regulation Checklist
Time frame: 5-7 weeks and 3 months
Positive and Negative Affect Scale
Time frame: 5-7 weeks and 3 months
Question-Asking Questionnaire
Time frame: 5-7 weeks and 3 months
Spence Children's Anxiety Scale
Time frame: 5-7 weeks, 3 months
MINI Kid 6.0 Parent Version
Time frame: 5-7 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonita P Klein-Tasman, Ph.D. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response Inhibition Training in people with Williams Syndrome, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Inhibition Tasks (time frame: 5-7 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.