Viewing Study NCT06331936



Ignite Creation Date: 2024-05-06 @ 8:18 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06331936
Status: RECRUITING
Last Update Posted: 2024-03-26
First Post: 2024-02-02

Brief Title: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen
Sponsor: City University of Hong Kong
Organization: City University of Hong Kong

Study Overview

Official Title: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 32 Each participant will attend four sessions of intervention and one booster session and each session requires around 15 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
Detailed 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 32 ratio Each participant will attend four intervention sessions Each session requires around 15 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 childrens emotional management skills and its correlation with mental health and family functioning among the participants

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None