The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Consent rate
研究概览
简要总结
The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Trained nursing students, who are the future nurses and well-equipped with basic health knowledge, as the interventionists to deliver a bCBTMI intervention to the eligible subjects. The result of this study is expected to provide evidence of the feasibility and effectiveness of training nursing students to conduct bCBTMI in Hong Kong Chinese adolescents with IA for a definitive RCT.
详细描述
A two-arm, parallel-group, feasibility cluster randomized controlled trial will be conducted. 60 adolescents with IA will be recruited from secondary schools in Hong Kong. Participants in the intervention group will receive 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by nursing students. Control group participants will receive routine care for IA.
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
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 13 to 17
- •Studying Forms 2 to 4
- •Classified as IA by the Chinese version of Young's 10-item Internet Addiction Test (IAT)
- •Can communicate in Cantonese and read Chinese.
排除标准
- •With physical or cognitive impairment and learning problems as identified from the medical records
结局指标
主要结局
Consent rate
时间窗: at the 6-month follow-up
Calculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.
Adverse events
时间窗: at the 6-month follow-up
Are defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study. The relation to the intervention will be assessed in accordance with the protocol for adverse events management (It can be provided upon request). The number and event severity will be recorded. Numbers and reasons for exclusions will be noted.
Attendance rate
时间窗: Immediately after the bCBTMI intervention
Calculated by dividing the number of secondary school students who complete the intervention by those who are randomized.
Screening rate
时间窗: at day 1
Calculated as the number of students screened at participated secondary schools divided by number of students at participated schools during the recruitment period.
Eligibility rate
时间窗: at day 1
Calculated by dividing the number of secondary school students who are eligible by the number who are screened.
Complete rate
时间窗: at the 6-month follow-up
Calculated by dividing the number of secondary school students who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Missing data
时间窗: at the 6-month follow-up
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Randomization rate
时间窗: at day 1
Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.
Retention rate
时间窗: at the 6-month follow-up
Calculated by dividing the number of secondary school students who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Adherence to intervention protocol
时间窗: at the 1-month follow-up
Calculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.
次要结局
- Self-reported abstinence at the 3-month follow-up(at the 3-month follow-up)
- Self-reported abstinence at the 6-month follow-up(at the 6-month follow-up)
- The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)(at the 6-month follow-up)
- Anxiety level(at the 6-month follow-up)
- Self-reported abstinence at the 1-week follow-up(at the 1-week follow-up)
- Self-reported abstinence at the 1-month follow-up(at the 1-month follow-up)
- Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)(at the 6-month follow-up)
研究者
Dr Katherine Lam
Research Assistant Professor
The Hong Kong Polytechnic University