Attention-Deficit/Hyperactivity DisorderNCT02732496
Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome
A study testing Targeted Cognitive Training (TCT) and Youth Appropriate Online Games in people with Attention-Deficit/Hyperactivity Disorder and Tourette Syndrome, run by Massachusetts General Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome
- What is being tested?
- Targeted Cognitive Training (TCT) and Youth Appropriate Online Games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 3 Nov 2017
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Computerized Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder and Comorbid Tourette Syndrome
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).
Read the 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.
- Being tested
- Targeted Cognitive Training (TCT), Youth Appropriate Online Games
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome, Working Memory Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cognitive Training (TCT)Behavioural
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.
Youth Appropriate Online GamesOther
Engaging games not designed to improve cognition.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Targeted Cognitive Training (TCT) Receives: Behavioral: Targeted Cognitive Training (TCT) |
| Youth Appropriate Online Games | Placebo comparator | Engaging games not designed to improve cognition Receives: Other: Youth Appropriate Online Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
The SWM subtest assesses working memory.
Measured: 3 months
Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
The SSP subtest assesses working memory.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 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 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Louis V. Gerstner III Research Scholar Award
- Responsible party
- Principal investigator, Mary Zelime Elibol, Massachusetts General Hospital
- Investigators
- M. Zelime Elibol, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732496
- Sponsor's protocol ID
- 2015P002512
- Status last verified
- Aug 2018
- First submitted
- 3 Mar 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder and Comorbid Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02732496
- Acronym / sponsor ID
- 2015P002512
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Tourette Syndrome, Working Memory Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Louis V. Gerstner III Research Scholar Award
- Study start
- Jun 2016 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 8 Apr 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Targeted Cognitive Training (TCT)Targeted Cognitive Training (TCT) |
| Youth Appropriate Online Games | Placebo comparator | Other: Youth Appropriate Online GamesEngaging games not designed to improve cognition |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Targeted Cognitive Training (TCT)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. | Behavioural | Cognitive Training |
| Youth Appropriate Online GamesEngaging games not designed to improve cognition. | Other | Youth Appropriate Online Games |
Primary outcome
Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: 3 months
The SWM subtest assesses working memory.
Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: 3 months
The SSP subtest assesses working memory.
The Working Memory Index from the Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 3 months
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)
Time frame: 3 months
Parent and teacher ratings on the Behavioral Regulation Index of the BRIEF assess working memory.
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 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
M. Zelime Elibol, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Cognitive Training (TCT) and Youth Appropriate Online Games in people with Attention-Deficit/Hyperactivity Disorder and Tourette Syndrome, run by Massachusetts General Hospital.
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 2 inclusion and 7 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB) (time frame: 3 months). The study lists 4 primary outcomes in all. 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 3 Aug 2018.