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

ADHD Clinical Trial

— ADHD+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071066
• Other study ID #: ADHD+HK
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2022
• Source: The University of Hong Kong
• Contact: Tsz To Chan
• Phone: 62247175
• Email: tszto[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)
Primary	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.	From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)