Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder Scale
研究概览
简要总结
The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session.
详细描述
- Context of study
The target population of this study is children in difficulty, which is defined as children who come from one of the following three groups: (1) single-parent families, (2) low-income families, and (3) left-behind children. Children in difficulty are constantly exposed to multiple sources of stress, including parental psychological neglect, unstable family life, limited school-based social activities, and stereotypes. These factors can bring emotional fluctuations in children. If they are not handled properly, it may lead to bullying, family conflicts, and even suicide. 2. Target of emotional regulation
There are still challenges and deficiencies in the coverage, quality, and synergy of emotional assistance services for children in need. This study helps children acquire emotional concepts and management skills and offers an evidence-based intervention framework for service providers. 3. Cultural and contextual considerations in the intervention feature
The current research revised the intervention manual, which was developed in the context of Hong Kong to adapt to mainland China. 4. Procedure
The researchers aim to recruit 200 children in difficulty to participate in the study. The age range of the participants is between 8 and 14. The participants will be randomly assigned to an experimental or wait-list control group with a 3:2 ratio. Each participant will attend four intervention sessions. Each session requires around 1.5 to 2 hours to complete. The pre-test, post-test, and follow-up survey each requires around 30 minutes to complete. The surveys are conducted to assess the effectiveness of the emotional management intervention on children's emotional management skills and its correlation with mental health and family functioning among the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
At the recruitment phase, the participants and the social workers who lead the intervention will not know which arm the participants will be assigned. A cluster of approximately 10 participants formed a group based on their attendance date in the intervention program. This group will be randomly assigned to one of the two intervention arms through pre-prepared randomization list calculated by random allocation software.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •single-parent families
- •low-income families
- •left-behind children
排除标准
- •a history of severe psychotic symptoms
- •have previously participated in a similar intervention program
结局指标
主要结局
Generalized Anxiety Disorder Scale
时间窗: Baseline, week 4, week 8
Generalized anxiety disorder questionnaire assesses the anxiety symptoms among parents and children. Possible scores for each item range from 1 (not at all) to 4 (everyday). Higher scores indicate more anxiety symptoms.
Subjective Happiness Scale
时间窗: Baseline, week 4, week 8
Subjective happiness scale is a 4-item scale assessing parents' and children's subjective happiness. Possible scores for each item range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate more subjective happiness.
10-item Positive and Negative Affect Schedule
时间窗: Baseline, week 4, week 8
Positive and negative affect schedule is a 10-item scale assessing parents' and children's positive and negative affect. Possible scores for each item range from 1 (not at all) to 6 (everyday). Higher scores indicate more positive or negative affect.
10-item Emotional Management Strategy Questionnaire
时间窗: Baseline, week 4, week 8
Emotional management strategy questionnaire is a 10-item scale assessing parents' and children's emotional management strategy. Possible scores for each item range from 1 (not at all) to 6 (everyday). Higher scores indicate more frequent use of emotional management strategy.
Patient Health Questionnaire-9
时间窗: Baseline, week 4, week 8
Patient health questionnaire assesses the depressive symptoms among parents and children. Possible scores for each item range from 1 (not at all) to 4 (everyday). Higher scores indicate more depressive symptoms.
Connor-Davidson Resilience Scale 10-Item
时间窗: Baseline, week 4, week 8
Connor-Davidson resilience scale assesses the individual resilience among parents and children. Possible scores for each item range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate greater resilience.
Child-Parent Relationship Scale
时间窗: Baseline, week 4, week 8
Child-parent relationship scale is a 4-item scale assessing the relationship between parents and children. Possible scores for each item range from 1 (very dissatisfied) to 6 (very satisfied). Higher scores indicate better satisfaction with parents.
Family Harmony Scale
时间窗: Baseline, week 4, week 8
Family harmony scale is an 8-item scale assessing the family harmony. Possible scores for each item range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate better family harmony.
次要结局
未报告次要终点
研究者
Dr. Nancy Xiaonan Yu
Associate Professor
City University of Hong Kong