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Clinical Trial Summary

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.


Clinical Trial Description

1. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06331936
Study type Interventional
Source City University of Hong Kong
Contact Nancy YU, Dr.
Phone 34429436
Email nancy.yu@cityu.edu.hk
Status Recruiting
Phase N/A
Start date January 6, 2024
Completion date September 2024

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