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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05071066
Collaborator
(none)
200
1
2
23.4
8.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ADHD+
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation for the Pilot Scheme on New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity ("ADHD+"): A Randomized Waitlist-controlled Trial
Actual Study Start Date :
Dec 20, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group-based ADHD+ Treatment

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.

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.

Other: wait-list control group

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.

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.

Outcome Measures

Primary Outcome Measures

  1. The change of overall ADHD and related symptoms [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 and teacher-report). The scale has 18 items, each rated from -3 to 3 following 7-point Likert scale. Higher scores indicate greater symptomology

Secondary Outcome Measures

  1. The change of functioning for service users under 18 years old [From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)]

    Measured by Children's Global Assessment Scale (CGAS) (for service users under 18 years old). The observer rates from Min: 1 to max:100. Higher scores indicate greater functioning.

  2. The change of autism spectrum disorder (ASD) diagnosis and symptoms [From Time 0 (Baseline) to Time 1 (post-intervention 3-month) to Time 2 (post-intervention 6-month)]

    Measured by Autism-Spectrum Quotient (AQ). The scale has 50 items, each rated from 0 - 3. Higher scores indicate greater autism spectrum disorder ASD symptoms.

  3. The change of difficult behavior in service users [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 15 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: YI Nam Suen, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Yi-Nam Suen, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05071066
Other Study ID Numbers:
  • ADHD+HK
First Posted:
Oct 7, 2021
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022