Response Inhibition Training for Children With Williams Syndrome

NCT02212314 | Completed

• 1 other identifier: 14.351
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Williams Syndrome

Keywords

Response Inhibition, Williams Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Conners-3

  5-7 weeks and 3 months

• Emotion Regulation Checklist

  5-7 weeks and 3 months

• Positive and Negative Affect Scale

  5-7 weeks and 3 months

• Question-Asking Questionnaire

  5-7 weeks and 3 months

• Spence Children's Anxiety Scale

  5-7 weeks, 3 months

Other Outcomes (2)

• Treatment Acceptability Questionnaire

  5-7 weeks

• Treatment Evaluation Inventory

  5-7 weeks

Study Arms (2)

Response Inhibition Training

EXPERIMENTAL

Treatment group will receive immediate treatment after pre-test.

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.

Interventions

Response Inhibition Training BEHAVIORAL

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

Response Inhibition Training

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

University of Wisconsin-Milwaukee Child Neurodevelopment Research Lab

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Williams Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Bonita P Klein-Tasman, Ph.D.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

US (1)