ADHDNCT04454008
RCT of EF Family Training for P ADHD
A study testing executive function family training and treat as usual in people with ADHD, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To explore the effect of executive function family training for preschool children with ADHD, providing early social psychological intervention for aiming the core impairments of ADHD. Read more about this study
- Who is it for?
- Ages 48 to 71 months
- Conditions the study is for
- ADHD
- What is being tested?
- executive function family training and treat as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2020to 30 Oct 2025
- 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 48 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meet the diagnostic criteria for preschool ADHD, based on the the DSM-5 criteria by the attending physician or above;
- Age 4 months 0 to 5 years 11 months;
- Total IQ is above 80 assessed by WPPSI.
Who cannot join
- Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders;
- parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school;
- Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital
Shanghai, 200092
Lan Shuai, Ph.D
About this study
Official title: Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study
To explore the effect of executive function family training for preschool children with ADHD, providing early social psychological intervention for aiming the core impairments of ADHD.
Read the detailed description
100 preschool children with ADHD will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes executive function training for ADHD children and parenting guidance for parents by two therapists respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are psychiatrists with a background in child psychiatry and psychotherapists with training in ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was compared.
- Conditions
- ADHD
- Being tested
- executive function family training, treat as usual
- Keywords
- ADHD, executive function, preschool, intervention, RCT
- 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.
executive function family trainingBehavioural
Intervention programs include executive function training for children with ADHD and parenting guidance for parents
treat as usualBehavioural
Outpatient routine health education, behavioral guidance and family support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents. Receives: Behavioral: executive function family training |
| waiting | Active comparator | The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic. Receives: Behavioral: treat as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD core symptoms
ADHD core symptoms are assessed by Swanson, Nolan, and Pelham Rating Scale (SNAP), with the score ranged from 0-54 (the higher the socre, the worse the symptoms)
Measured: 12 weeks after baseline
Secondary outcomes (2)
Executive function-Inhibition
The executive function inhibition is assessed by NEPSY-II task Status (ST) with the higher the score is, the better the function.
Measured: 12 weeks after baseline
Executive function-working memory
The executive function working memory is assessed by NEPSY-II task memory design (MD) with the higher the score is, the better the function.
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start6 Dec 2020
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2025 (estimated)
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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinsong Zhang, Doctor, Study director, Director of department of psychology, xinhua hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454008
- Sponsor's protocol ID
- XH-20-012
- Status last verified
- May 2020
- First submitted
- 27 Jun 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04454008
- Acronym / sponsor ID
- XH-20-012
- Conditions
- ADHD
- Keywords
- ADHD, executive function, preschool, intervention, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 1 Jul 2020 (actual)
- 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.
To explore the effect of executive function family training for preschool children with ADHD, providing early social psychological intervention for aiming the core impairments of ADHD.
Detailed description
100 preschool children with ADHD will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes executive function training for ADHD children and parenting guidance for parents by two therapists respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are psychiatrists with a background in child psychiatry and psychotherapists with training in ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: executive function family trainingThe intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents. |
| waiting | Active comparator | Behavioral: treat as usualThe waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic. |
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Meet the diagnostic criteria for preschool ADHD, based on the the DSM-5 criteria by the attending physician or above;
- Age 4 months 0 to 5 years 11 months;
- Total IQ is above 80 assessed by WPPSI.
Key exclusion criteria (3 listed)
- Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders;
- parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school;
- Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).
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 |
|---|---|---|
| executive function family trainingIntervention programs include executive function training for children with ADHD and parenting guidance for parents | Behavioural | Intervention |
| treat as usualOutpatient routine health education, behavioral guidance and family support | Behavioural | waiting |
Primary outcome
ADHD core symptoms
Time frame: 12 weeks after baseline
ADHD core symptoms are assessed by Swanson, Nolan, and Pelham Rating Scale (SNAP), with the score ranged from 0-54 (the higher the socre, the worse the symptoms)
2 secondary outcomes
Executive function-Inhibition
Time frame: 12 weeks after baseline
Executive function-working memory
Time frame: 12 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Jinsong Zhang, Doctor study director
Director of department of psychology, xinhua hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing executive function family training and treat as usual in people with ADHD, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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?
Contact Jinsong Zhang, Doctor (008613651601596, zhangjinsong@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD core symptoms (time frame: 12 weeks after baseline). 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 22 Mar 2021.