protocolSection identificationModule nctId: NCT06331936, orgStudyIdInfo id: Shenzhen Project, briefTitle: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: City University of Hong Kong, class: OTHER, collaborators name: International Social Service Hong Kong Branch, descriptionModule briefSummary: 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., conditionsModule conditions: Emotion Regulation, conditions: Parent-Child Relations, conditions: Happiness, conditions: Positive Affect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Children will be randomly assigned to two groups: intervention and waitlist control groups. Children in the waitlist control group will receive experimental intervention after treatment for the experimental group finishes., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Emotion regulation, outcomesModule primaryOutcomes measure: 10-item Emotional Management Strategy Questionnaire, primaryOutcomes measure: 10-item Positive and Negative Affect Schedule, primaryOutcomes measure: Patient Health Questionnaire-9, primaryOutcomes measure: Generalized Anxiety Disorder Scale, primaryOutcomes measure: Subjective Happiness Scale, primaryOutcomes measure: Connor-Davidson Resilience Scale 10-Item, primaryOutcomes measure: Child-Parent Relationship Scale, primaryOutcomes measure: Family Harmony Scale, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: City University of Hong Kong, status: RECRUITING, city: Hong Kong, country: China, contacts name: Nancy Xiaonan YU, Ph.D., role: CONTACT, phone: (852)34429436, email: nancy.yu@cityu.edu.hk, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False