Attention Deficit Hyperactivity DisorderPhase 1NCT02327585
Behavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)
A Phase 1 study of Attention Deficit Hyperactivity Disorder, run by Min Chen at 1 site in China.
Trial summary
ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- 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
- Jun 2013to Dec 2016
- Phase
- Phase 1
- 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
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of child ADHD
- full-scale intelligence quotient (FSIQ) ≥70
- stable on medication for ADHD children at least 3 months
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, 1 recruiting
- Recruiting
Peking University Sixth Hospital/Institute of Mental Health
Beijing, 100191
Li Yang, PHD, 13651220707, puh60346@bjmu.edu.cn
About this study
Official title: Study on the Psychological Behavior Intervention Technology of Attention Deficit Hyperactivity Disorder
ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- A randomized controlled study of Executive Function training for children with ADHD
- Keywords
- Executive function training, child
- 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.
A randomized controlled study of Executive Function training for children with ADHDBehavioural
Children diagnosis of ADHD are randomized to the experimental condition(Executive Function therapy) or waiting group experimental:participants will receive 12 sessions of executive function therapy weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison
| Study group | Role | What they receive |
|---|---|---|
| Executive function training | Experimental | Children diagnosis of ADHD are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of executive function training weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison Receives: Behavioral: A randomized controlled study of Executive Function training for children with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ADHD-rating scale
Measured: baseline,after the training (12week)
Secondary outcomes (3)
change in behavior rating scale of executive function
Measured: baseline,after the training (12week)
cambridge Neuropsychological Test Automatic Battery
Measured: baseline,after the training (12week)
Conners
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 posted30 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Chen, Peking University
- Investigators
- li yang, PHD MD, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327585
- Sponsor's protocol ID
- 2011-4024-04
- Status last verified
- Dec 2014
- First submitted
- 12 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.
PubMed 28639564
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Psychological Behavior Intervention Technology of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02327585
- Acronym / sponsor ID
- 2011-4024-04
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Executive function training, child
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Min ChenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Dec 2014 (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.
ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Executive function training | Experimental | Behavioral: A randomized controlled study of Executive Function training for children with ADHDChildren diagnosis of ADHD are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of executive function training weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinical diagnosis of child ADHD
- full-scale intelligence quotient (FSIQ) ≥70
- stable on medication for ADHD children at least 3 months
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 |
|---|---|---|
| A randomized controlled study of Executive Function training for children with ADHDChildren diagnosis of ADHD are randomized to the experimental condition(Executive Function therapy) or waiting group experimental:participants will receive 12 sessions of executive function therapy weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison | Behavioural | Executive function training |
Primary outcome
change in ADHD-rating scale
Time frame: baseline,after the training (12week)
3 secondary outcomes
change in behavior rating scale of executive function
Time frame: baseline,after the training (12week)
cambridge Neuropsychological Test Automatic Battery
Time frame: baseline,after the training (12week)
Conners
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 31 Dec 2014.
- Derived from this study: PubMed 28639564Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.
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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.
li yang, PHD MD study director
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Attention Deficit Hyperactivity Disorder, run by Min Chen 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 3 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 31 Dec 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact min chen, postgraduate (18813185425, 453560026@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in ADHD-rating scale (time frame: baseline,after the training (12week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327585, which also lists 1 linked publication.
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 31 Dec 2014.