ADHDNCT02562469
ACTIVATE: A Computerized Training Program for Children With ADHD
A study testing ACTIVATE in people with ADHD, run by New York University at 1 site in United States.
Trial summary
A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- ACTIVATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Aug 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 7-11 with a diagnosis of ADHD
- Parent and child must be fluent English speakers
- Family has access to desktop/laptop computer at home with internet access (in order to implement the ACTIVATE intervention component, which is an online-based computer program)
Who cannot join
- Developmental delay or psychosis that impacts the child's ability to function and engage in the computerized intervention
- If the youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within a preventive intervention format (e.g. hospitalization, specialized placement outside the home)
- If the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Intelligence Scale for Children - Fourth Edition
Trial locations and contacts
1 site in 1 country.
About this study
A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking).
Read the detailed description
In an open clinical trial, ACTIVATE, a computer-based neurocognitive intervention will be evaluated to determine its effectiveness in improving symptoms of attention-deficit/hyperactivity disorder (ADHD) and related impairments. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). Youth between the ages of 7-11 will be recruited and assessed for ADHD and assigned to the ACTIVATE intervention. Assessment of outcomes will occur before, weekly during treatment, and immediately post-treatment.
- Conditions
- ADHD
- Being tested
- ACTIVATE
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVATEOther
A home-based computerized brain training intervention for youth.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVATE | Experimental | ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). ACTIVATE Is completed at home via computer with parent support. ACTIVATE intervention is conducted 3-5 times per week for between 20-30 minutes over the course or 3-4 months. Receives: Other: ACTIVATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms on the Disruptive Behavior Rating Scale
Change in ADHD symptoms over the course of treatment
Measured: Change in ADHD symptoms at postreatment, which is expected to occur betwen 12-18 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562469
- Sponsor's protocol ID
- ACTIVATE
- Status last verified
- Sep 2018
- First submitted
- 3 Jun 2015
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVATE: A Computerized Training Program for Children With ADHD
- ClinicalTrials.gov ID
- NCT02562469
- Acronym / sponsor ID
- ACTIVATE
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Sep 2015 (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.
A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking).
Detailed description
In an open clinical trial, ACTIVATE, a computer-based neurocognitive intervention will be evaluated to determine its effectiveness in improving symptoms of attention-deficit/hyperactivity disorder (ADHD) and related impairments. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). Youth between the ages of 7-11 will be recruited and assessed for ADHD and assigned to the ACTIVATE intervention. Assessment of outcomes will occur before, weekly during treatment, and immediately post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTIVATE | Experimental | Other: ACTIVATEACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). ACTIVATE Is completed at home via computer with parent support. ACTIVATE intervention is conducted 3-5 times per week for between 20-30 minutes over the course or 3-4 months. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 7-11 with a diagnosis of ADHD
- Parent and child must be fluent English speakers
- Family has access to desktop/laptop computer at home with internet access (in order to implement the ACTIVATE intervention component, which is an online-based computer program)
Key exclusion criteria (3 listed)
- Developmental delay or psychosis that impacts the child's ability to function and engage in the computerized intervention
- If the youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within a preventive intervention format (e.g. hospitalization, specialized placement outside the home)
- If the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Intelligence Scale for Children - Fourth Edition
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 |
|---|---|---|
| ACTIVATEA home-based computerized brain training intervention for youth. | Other | ACTIVATE |
Primary outcome
ADHD symptoms on the Disruptive Behavior Rating Scale
Time frame: Change in ADHD symptoms at postreatment, which is expected to occur betwen 12-18 weeks from start of treatment
Change in ADHD symptoms over the course of treatment
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 2 Nov 2022.
- Families and Children Experiencing Success (FACES) LabLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVATE in people with ADHD, run by New York University 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 3 inclusion and 3 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 2 Nov 2022. 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?
ADHD symptoms on the Disruptive Behavior Rating Scale (time frame: Change in ADHD symptoms at postreatment, which is expected to occur betwen 12-18 weeks from start of treatment). 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 2 Nov 2022.