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

Primary Purpose

ADHD

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ADHD+
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group-based ADHD+ Treatment

wait-list control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
September 14, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05071066
Brief Title
New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity: A Randomized Waitlist-controlled
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-based ADHD+ Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
wait-list control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ADHD+
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of overall ADHD and related symptoms
Description
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
Time Frame
From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)
Title
The change of difficult behavior in service users
Description
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.
Time Frame
From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsz To Chan
Phone
62247175
Email
tszto@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YI Nam Suen, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Nam Suen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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