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Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome

Primary Purpose

Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Targeted Cognitive Training (TCT)

Youth Appropriate Online Games

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome, Working Memory Training

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The investigators will limit inclusion to youth between the ages of 7-13 who carry current diagnoses of ADHD+TS and who have a treating physician at a Partners affiliated hospital or clinic.
The investigators will include youth who have undergone neuropsychological testing in the prior 3 years.

Exclusion Criteria:

The investigators will exclude patients with intellectual disability in order to more directly extend the prior literature to the ADHD+TS population.
The investigators will exclude patients with severe tics as evidenced by a score of > 30 on the clinician administered Yale Global Tic Severity Scale (YGTSS).
The investigators will exclude patients with moderate to severe Obsessive Compulsive Disorder (OCD) symptoms, as evidenced by a score of >30 on the clinician administered Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS).
The investigators will exclude patients treated with neuroleptics, given that these medications can be cognitively dulling and sedating and potentially lead to secondary working memory impairments.
The investigators will exclude families who do not have a computer with an internet connection in their homes, and in which neither a parent nor the child has an email address to receive study related communications.
The investigators will exclude families who anticipate or are likely to have a change in therapeutic treatments (i.e., psychotherapy or psychopharmacology) during the time frame of the trial.

NOTE: Patients treated with ADHD medications will not be excluded, but medications will be recorded for covariate analysis.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive Training

Youth Appropriate Online Games

Arm Description

Targeted Cognitive Training (TCT)

Engaging games not designed to improve cognition

Outcomes

Primary Outcome Measures

Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

The SWM subtest assesses working memory.

Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

The SSP subtest assesses working memory.

The Working Memory Index from the Behavior Rating Inventory of Executive Function (BRIEF)

Parent and teacher ratings on the Working Memory Index of the BRIEF assess working memory.

The Behavioral Regulation Index from the Behavior Rating Inventory of Executive Function (BRIEF)

Parent and teacher ratings on the Behavioral Regulation Index of the BRIEF assess working memory.

Secondary Outcome Measures

Full Information

NCT ID

NCT02732496

First Posted

March 3, 2016

Last Updated

August 2, 2018

Sponsor

Massachusetts General Hospital

Collaborators

Louis V. Gerstner III Research Scholar Award

1. Study Identification

Unique Protocol Identification Number

NCT02732496

Brief Title

Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome

Official Title

Computerized Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder and Comorbid Tourette Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

November 3, 2017 (Actual)

Study Completion Date

November 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Louis V. Gerstner III Research Scholar Award

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting working memory in 30 children with comorbid Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).

Detailed Description

Because impairments in executive functions (EFs), such as working memory, are associated with functional impairments in youth with neurodevelopmental and neuropsychiatric disorders, strategies that target EFs are critical. Neuroplasticity-based cognitive training has been found to improve cognition in youth with ADHD and in adults with schizophrenia. In this trial, the investigators seek to extend the relevance of computerized cognitive training to youth with comorbid ADHD and Tourette Syndrome. Given the literature, the investigators hypothesize that computerized working memory training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with ADHD+TS. The investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity-based cognitive training or enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be assessed again after 30 training sessions over 6 weeks and then again at a one-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome

Keywords

Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome, Working Memory Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Training

Arm Type

Experimental

Arm Description

Targeted Cognitive Training (TCT)

Arm Title

Youth Appropriate Online Games

Arm Type

Placebo Comparator

Arm Description

Engaging games not designed to improve cognition

Intervention Type

Behavioral

Intervention Name(s)

Targeted Cognitive Training (TCT)

Intervention Description

The instructors have selected a set of computer exercises designed to specifically target working memory, which is a cognitive construct relevant to ADHD and Tourette Syndrome. The tasks were designed to benefit subjects through principles of learning-dependent plasticity.

Intervention Type

Other

Intervention Name(s)

Youth Appropriate Online Games

Intervention Description

Engaging games not designed to improve cognition.

Primary Outcome Measure Information:

Title

Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

Description

The SWM subtest assesses working memory.

Time Frame

3 months

Title

Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

Description

The SSP subtest assesses working memory.

Time Frame

3 months

Title

The Working Memory Index from the Behavior Rating Inventory of Executive Function (BRIEF)

Description

Parent and teacher ratings on the Working Memory Index of the BRIEF assess working memory.

Time Frame

3 months

Title

The Behavioral Regulation Index from the Behavior Rating Inventory of Executive Function (BRIEF)

Description

Parent and teacher ratings on the Behavioral Regulation Index of the BRIEF assess working memory.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The investigators will limit inclusion to youth between the ages of 7-13 who carry current diagnoses of ADHD+TS and who have a treating physician at a Partners affiliated hospital or clinic. The investigators will include youth who have undergone neuropsychological testing in the prior 3 years. Exclusion Criteria: The investigators will exclude patients with intellectual disability in order to more directly extend the prior literature to the ADHD+TS population. The investigators will exclude patients with severe tics as evidenced by a score of > 30 on the clinician administered Yale Global Tic Severity Scale (YGTSS). The investigators will exclude patients with moderate to severe Obsessive Compulsive Disorder (OCD) symptoms, as evidenced by a score of >30 on the clinician administered Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS). The investigators will exclude patients treated with neuroleptics, given that these medications can be cognitively dulling and sedating and potentially lead to secondary working memory impairments. The investigators will exclude families who do not have a computer with an internet connection in their homes, and in which neither a parent nor the child has an email address to receive study related communications. The investigators will exclude families who anticipate or are likely to have a change in therapeutic treatments (i.e., psychotherapy or psychopharmacology) during the time frame of the trial. NOTE: Patients treated with ADHD medications will not be excluded, but medications will be recorded for covariate analysis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M. Zelime Elibol, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome

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