- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06331936
Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
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.
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.
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- City University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- single-parent families
- low-income families
- left-behind children
Exclusion Criteria:
- a history of severe psychotic symptoms
- have previously participated in a similar intervention program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
The intervention arm aims at improving children's emotional regulation skills.
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Each participant will attend four intervention sessions.
They will also be invited to a booster Session, where they will be invited for interviews to share what they have gained from the sessions.
The contents of the intervention and the booster session are as follows: (1) understand emotions, (2) attention and positivity, (3) emotional regulation, (4) connectedness and intimacy, and (5) review and sharing.
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No Intervention: Control Arm
The control arm participants will not receive any interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10-item Emotional Management Strategy Questionnaire
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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10-item Positive and Negative Affect Schedule
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Patient Health Questionnaire-9
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Generalized Anxiety Disorder Scale
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Subjective Happiness Scale
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Connor-Davidson Resilience Scale 10-Item
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Child-Parent Relationship Scale
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Family Harmony Scale
Time Frame: Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy YU, Dr., City University of Hong Kong
Publications and helpful links
General Publications
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
- Yu X, Tam WW, Wong PT, Lam TH, Stewart SM. The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012 Jan;53(1):95-102. doi: 10.1016/j.comppsych.2010.11.002. Epub 2010 Dec 28.
- Fabrizio CS, Lam TH, Hirschmann MR, Pang I, Yu NX, Wang X, Stewart SM. Parental emotional management benefits family relationships: A randomized controlled trial in Hong Kong, China. Behav Res Ther. 2015 Aug;71:115-24. doi: 10.1016/j.brat.2015.05.011. Epub 2015 Jun 4.
- Driscoll, K., & Pianta, R. C. (1992). Child-Parent Relationship Scale. Journal of Early Childhood and Infant Psychology. https://doi.org/10.1037/t16909-000
- Kroenke, K., & Spitzer, R. L. (2002). The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiatric Annals, 32(9), 509-515. https://doi.org/10.3928/0048-5713-20020901-06
- Lyubomirsky, S., Lepper, H.S. A Measure of Subjective Happiness: Preliminary Reliability and Construct Validation. Social Indicators Research, 46, 137-155 (1999). https://doi.org/10.1023/A:1006824100041
- Yu, N. X., Kam-fung Liu, I., & Bu, H. (2021). Enhancing resilience in cross boundary families: A parent-child parallel group intervention. Journal of Social Work, 21(4), 651-675. https://doi.org/10.1177/1468017320919103
- Zhang C, Wang T, Zeng P, Zhao M, Zhang G, Zhai S, Meng L, Wang Y, Liu D. Reliability, Validity, and Measurement Invariance of the General Anxiety Disorder Scale Among Chinese Medical University Students. Front Psychiatry. 2021 May 19;12:648755. doi: 10.3389/fpsyt.2021.648755. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shenzhen Project
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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