Attention Deficit Hyperactivity DisorderNCT02656758
Intensive Executive Function Training
A study testing intensive Executive function training in people with Attention Deficit Hyperactivity Disorder, run by ZIli Fan at 1 site in China.
Trial summary
The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- intensive Executive function training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2018
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- clinical diagnosis of child attention deficit hyperactivity disorder
- full-scale intelligence quotient (FSIQ) ≥70
- stable on medication for attention deficit hyperactivity disorder children at least 3 months
- participation in the early implementation of functional training one year before
Who cannot join
- individuals with major neurological disorders
- a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Sixth Hospital/Institute of Mental Health
Beijing, Beijing Municipality, 100191
About this study
Official title: A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder
The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- intensive Executive function training
- 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.
intensive Executive function trainingBehavioural
Children diagnosis of attention deficit hyperactivity disorder are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of intensive executive function training weekly no intervention :waiting participants will not be treated with intensive executive function training and keep waiting for 12 weeks for comparison
| Study group | Role | What they receive |
|---|---|---|
| Executive function training | Experimental | the experimental group will receive 12 sessions of intensive Executive function training weekly immediately Receives: Behavioral: intensive Executive function training |
| the waitlist group | Other | the waitlist group will wait 12 weeks before receiving intensive executive function training for comparison. Receives: Behavioral: intensive Executive function training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention deficit hyperactivity disorder-rating scale
Measured: baseline, after the training (12 weeks)
Secondary outcomes (3)
Change in behavior rating scale of executive function
Measured: baseline, after the training (12 weeks)
Cambridge Neuropsychological Test Automatic Battery
Measured: baseline, after the training (12 weeks)
Behavior Rating Inventory of Executive Function
Measured: baseline, after the training (12week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
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.
- 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, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZIli Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZIli Fan, Peking University
- Investigators
- Ying Qian, Principal investigator, Peking University Sixth Hospital/Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656758
- Sponsor's protocol ID
- Z151100004015103
- Status last verified
- Oct 2016
- First submitted
- 11 Jan 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02656758
- Acronym / sponsor ID
- Z151100004015103
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ZIli FanUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jan 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 intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive function training | Experimental | Behavioral: intensive Executive function trainingthe experimental group will receive 12 sessions of intensive Executive function training weekly immediately |
| the waitlist group | Other | Behavioral: intensive Executive function trainingthe waitlist group will wait 12 weeks before receiving intensive executive function training for comparison. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- clinical diagnosis of child attention deficit hyperactivity disorder
- full-scale intelligence quotient (FSIQ) ≥70
- stable on medication for attention deficit hyperactivity disorder children at least 3 months
- participation in the early implementation of functional training one year before
Key exclusion criteria (2 listed)
- individuals with major neurological disorders
- a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
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 |
|---|---|---|
| intensive Executive function trainingChildren diagnosis of attention deficit hyperactivity disorder are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of intensive executive function training weekly no intervention :waiting participants will not be treated with intensive executive function training and keep waiting for 12 weeks for comparison | Behavioural | Executive function training, the waitlist group |
Primary outcome
Change in attention deficit hyperactivity disorder-rating scale
Time frame: baseline, after the training (12 weeks)
3 secondary outcomes
Change in behavior rating scale of executive function
Time frame: baseline, after the training (12 weeks)
Cambridge Neuropsychological Test Automatic Battery
Time frame: baseline, after the training (12 weeks)
Behavior Rating Inventory of Executive Function
Time frame: baseline, after the training (12week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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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.
Ying Qian principal investigator
Peking University Sixth Hospital/Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive Executive function training in people with Attention Deficit Hyperactivity Disorder, run by ZIli Fan at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2016. 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 China. 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?
Results are not available in the source record.
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?
Change in attention deficit hyperactivity disorder-rating scale (time frame: baseline, after the training (12 weeks)). 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 11 Oct 2016.