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New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity: A Randomized Waitlist-controlled

Evaluation for the Pilot Scheme on New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity (ADHD+): A Randomized Waitlist-controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05071066
Acronym
ADHD+
Enrollment
200
Registered
2021-10-07
Start date
2021-12-20
Completion date
2023-12-01
Last updated
2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Brief 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. 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.

Interventions

OTHERADHD+

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The change of overall ADHD and related symptomsFrom 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 usersFrom 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.

Countries

Hong Kong

Contacts

Primary ContactTsz To Chan
tszto@hku.hk62247175

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026