ADHDADHD+NCT05071066
New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity: A Randomized Waitlist-controlled
A study testing ADHD+ in people with ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The proposed study is to be carried out in 2021 - 2024 with youths aged 6 - 15 in Hong Kong. This is a randomized waitlist-controlled trial that aims to examine the effectiveness of the ADHD+ new service protocol. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- ADHD
- What is being tested?
- ADHD+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Dec 2021to 1 Dec 2023
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children, adolescent and young adults (Aged 6-15);
- have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;
- clinically significant mild to moderate ADHD syndromes requiring intervention;
- without learning disabilities and intelligence quotient (IQ) score not lower than 70;
- are "more likely to commit time in the projects" for reasons such as intention to treat and
- receiving the New ADHD+ service.
Who cannot join
- known diagnosis of intellectual disability;
- not reaching syndrome diagnostic threshold for ADHD;
- already receiving medical interventions / treatments at Hospital Authority (HA) and/or private sector;
- known psychiatric diagnosis (stabilized diagnosis and treatment);
- current or active suicidal ideation or attempts;
- have received structured psychosocial intervention for more than 3 contact hours (for waitlist group); and
- refusal to give consent.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
Yi Nam Suen
About this study
Official title: Evaluation for the Pilot Scheme on New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity ("ADHD+"): A Randomized Waitlist-controlled Trial
The proposed study is to be carried out in 2021 - 2024 with youths aged 6 - 15 in Hong Kong. This is a randomized waitlist-controlled trial that aims to examine the effectiveness of the ADHD+ new service protocol. This ADHD+ new service protocol intervention will be delivered for 6 months in the format of groups by frontline social workers trained by professional clinicians including clinical psychologists and psychiatrists. It is designed to reduce ADHD and related symptoms in individuals aged between 6 and 15 years.
Core treatment components include internet use/addiction intervention, cognitive training, emotion management, social skills training, occupational training, emotion support/befriending, parenting training, and career guidance. It is hypothesized that youths receiving the intervention will have reduced ADHD and related symptoms when compared with controls.
Findings will allow the investigators to better understand the effectiveness of the new ADHD+ service; and in the long run, the service model can be generalized to community based early interventions for other uncomplicated mental disorders.
- Conditions
- ADHD
- Being tested
- ADHD+
- 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.
ADHD+Other
The group-based intervention is designed to reduce participants' ADHD and related symptoms. The content of the treatment will follow an established manual which is developed by an expert group comprised of psychiatrists and clinical psychologists. Core treatment components include internet use/addiction intervention, cognitive training, emotion management, social skills training, occupational training, emotion support/befriending, parenting training, and career guidance.
The main intervention lasts for 3 months, and the booster intervention lasts for another 3 months. The post- intervention assessments (3-month [T1], and 6-month [T2]) will be administered to all participants. During the period of intervention, all participants shall be clean from other forms of interventions to reduce any other possible confounders.
| Study group | Role | What they receive |
|---|---|---|
| Group-based ADHD+ Treatment | Experimental | This randomized controlled trial (RCT) will run in multi-sites including 5 non-governmental organizations (NGOs) in Hong Kong. Core treatment components are developed by an expert group comprised of psychiatrists and clinical psychologists including internet use/addiction intervention, cognitive training, etc.
The main intervention lasts for 3 months, and the booster intervention lasts for another 3 months. Receives: Other: ADHD+ |
| wait-list control group | Other | For participants in the waiting list control group, they will receive 1-3 hours psychoeducation during the 3 months wait period. Appropriate intervention will be offered after the treatment group. Receives: Other: ADHD+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of overall ADHD and related symptoms
Measured by Strengths and Weaknesses of ADHD-symptoms and Normal-behaviors questionnaire (SWAN) (for service users under 18 years old) (parent report). The scale has 18 items, each rated from -3 to 3 following 7-point Likert scale. Higher scores indicate greater symptomology
Measured: From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)
The change of difficult behavior in service users
Measured by Strengths and Difficulties Questionnaires (SDQ) [children version]. The scale has 25 items, each rated from 0 - 2. Higher score indicate more difficult behaviors.
Measured: From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start20 Dec 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (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 The University of Hong KongThe 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yi-Nam Suen, The University of Hong Kong
- Investigators
- YI Nam Suen, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071066
- Sponsor's protocol ID
- ADHD+HK
- Acronym
- ADHD+
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2021
- Last updated
- 16 Sep 2022
- 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for the Pilot Scheme on New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity ("ADHD+"): A Randomized Waitlist-controlled Trial
- ClinicalTrials.gov ID
- NCT05071066
- Acronym / sponsor ID
- ADHD+ / ADHD+HK
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Oct 2021 (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.
The proposed study is to be carried out in 2021 - 2024 with youths aged 6 - 15 in Hong Kong. This is a randomized waitlist-controlled trial that aims to examine the effectiveness of the ADHD+ new service protocol. This ADHD+ new service protocol intervention will be delivered for 6 months in the format of groups by frontline social workers trained by professional clinicians including clinical psychologists and psychiatrists. It is designed to reduce ADHD and related symptoms in individuals aged between 6 and 15 years.
Core treatment components include internet use/addiction intervention, cognitive training, emotion management, social skills training, occupational training, emotion support/befriending, parenting training, and career guidance. It is hypothesized that youths receiving the intervention will have reduced ADHD and related symptoms when compared with controls.
Findings will allow the investigators to better understand the effectiveness of the new ADHD+ service; and in the long run, the service model can be generalized to community based early interventions for other uncomplicated mental disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based ADHD+ Treatment | Experimental | Other: ADHD+This randomized controlled trial (RCT) will run in multi-sites including 5 non-governmental organizations (NGOs) in Hong Kong. Core treatment components are developed by an expert group comprised of psychiatrists and clinical psychologists including internet use/addiction intervention, cognitive training, etc. The main intervention lasts for 3 months, and the booster intervention lasts for another 3 months. |
| wait-list control group | Other | Other: ADHD+For participants in the waiting list control group, they will receive 1-3 hours psychoeducation during the 3 months wait period. Appropriate intervention will be offered after the treatment group. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children, adolescent and young adults (Aged 6-15);
- have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;
- clinically significant mild to moderate ADHD syndromes requiring intervention;
- without learning disabilities and intelligence quotient (IQ) score not lower than 70;
- are "more likely to commit time in the projects" for reasons such as intention to treat and
Key exclusion criteria (7 listed)
- known diagnosis of intellectual disability;
- not reaching syndrome diagnostic threshold for ADHD;
- already receiving medical interventions / treatments at Hospital Authority (HA) and/or private sector;
- known psychiatric diagnosis (stabilized diagnosis and treatment);
- current or active suicidal ideation or attempts;
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 |
|---|---|---|
| ADHD+The group-based intervention is designed to reduce participants' ADHD and related symptoms. The content of the treatment will follow an established manual which is developed by an expert group comprised of psychiatrists and clinical psychologists. Core treatment components include internet use/addiction intervention, cognitive training, emotion management, social skills training, occupational training, emotion support/befriending, parenting training, and career guidance. The main intervention lasts for 3 months, and the booster intervention lasts for another 3 months. The post- intervention assessments (3-month [T1], and 6-month [T2]) will be administered to all participants. During the period of intervention, all participants shall be clean from other forms of interventions to reduce any other possible confounders. | Other | Group-based ADHD+ Treatment, wait-list control group |
Primary outcome
The change of overall ADHD and related symptoms
Time frame: From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)
Measured by Strengths and Weaknesses of ADHD-symptoms and Normal-behaviors questionnaire (SWAN) (for service users under 18 years old) (parent report). The scale has 18 items, each rated from -3 to 3 following 7-point Likert scale. Higher scores indicate greater symptomology
The change of difficult behavior in service users
Time frame: From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)
Measured by Strengths and Difficulties Questionnaires (SDQ) [children version]. The scale has 25 items, each rated from 0 - 2. Higher score indicate more difficult behaviors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- 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.
YI Nam Suen, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD+ in people with ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 16 Sep 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 Hong Kong. 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 Tsz To Chan (62247175, tszto@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of overall ADHD and related symptoms (time frame: From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)). The study lists 2 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 16 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.