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临床试验/NCT06170996
NCT06170996已完成不适用

Internet-Based Behavioural Parent Training Intervention for Children With Attention-Deficit/Hyperactivity Disorder

Wuhan Mental Health Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)

研究概览

简要总结

This study aims to investigate the effectiveness of an Internet-based behavioural parent training intervention on children's ADHD symptoms and children's and parents' mental health status.

详细描述

The study design was a 2-parallel-group experimental longitudinal study. Firstly, the children received a diagnostic interview by an experienced child and adolescent psychiatrist at Wuhan Mental Health Centre for confirmation of inclusion and exclusion criteria. Parents who were eligible for the inclusion criteria and interested in the internet-based behavioural Parent Training (I-BPT) program were recruited. After the assessments of ADHD symptoms and psychiatric comorbidity, participants were randomly assigned in a 1:1 ratio to either the routine clinical care (RCC) group or I-BPT+RCC group using computer-generated randomization numbers. Participants in the I-BPT+RCC group were offered 2 months (8 weeks) of internet-assisted parent training in addition to routine outpatient treatment. The RCC group initially received only routine outpatient treatment, yet, after post-follow-up assessment, they were provided with the same I-BPT intervention for ethical considerations. Both groups were followed up after intervention by electronic questionnaire.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1.Meeting the diagnostic criteria for ADHD in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
  • 2.Total IQ greater than 70 as measured by the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV)
  • 3.Child and their parents consent to the study

排除标准

  • 1.Children or parents with severe organic encephalopathy and other severe mental disorders
  • 2.Has received or is receiving behavioral treatment (parent training)
  • 3.Parents who could not understand or lacking of access to computers and the Internet

结局指标

主要结局

Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)

时间窗: From baseline to 2 months

This questionnaire consists of two symptom domains: inattention (9 items) and hyperactivity/impulsivity (9 items). Each item of SNAP-IV assigned a score from 0 (never or rarely) to 3 (very often), with a higher score indicating more severe ADHD symptoms.

Weiss Functional Impairment Scale-Parent form (WFIRS-P)

时间窗: From baseline to 2 months

This scale consists of 50 items, each with a score ranging from 0 to 3, a higher average score indicates a greater impairment.

次要结局

  • Parenting Stress Index-Short Form (PSI-SF)(From baseline to 2 months)
  • Screen for Child Anxiety Related Emotional Disorders (SCARED)(From baseline to 2 months)
  • Children's Depression Inventory-Short Form (CDI-S)(From baseline to 2 months)
  • The nine-item version of the Patient Health Questionnaire (PHQ-9)(From baseline to 2 months)
  • Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)(posttest: 2 months to pretest)
  • The seven-item version of the Generalized Anxiety Disorder (GAD-7)(From baseline to 2 months)

研究者

发起方
Wuhan Mental Health Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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