Evaluation for the Pilot Scheme on New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity ("ADHD+"): A Randomized Waitlist-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The change of overall ADHD and related symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ADHD+ (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.
干预措施: ADHD+ (Other)
结局指标
主要结局
The change of overall ADHD and related symptoms
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Yi-Nam Suen
Research Assistant Professor
The University of Hong Kong