Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen

Parent-Child Relations Clinical Trial

Official title:

Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331936
• Other study ID #: Shenzhen Project
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2024
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: City University of Hong Kong
• Contact: Nancy YU, Dr.
• Phone: 34429436
• Email: nancy.yu[@]cityu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation
• Happiness
• Parent-Child Relations
• Positive Affect

Intervention

Behavioral:
• Emotion regulation
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.

Locations

Country	Name	City	State
China	City University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
City University of Hong Kong	International Social Service Hong Kong Branch

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. — View Citation

Driscoll, K., & Pianta, R. C. (1992). Child-Parent Relationship Scale. Journal of Early Childhood and Infant Psychology. https://doi.org/10.1037/t16909-000

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-item Emotional Management Strategy Questionnaire	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.	Baseline, week 4, week 8
Primary	10-item Positive and Negative Affect Schedule	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.	Baseline, week 4, week 8
Primary	Patient Health Questionnaire-9	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.	Baseline, week 4, week 8
Primary	Generalized Anxiety Disorder Scale	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.	Baseline, week 4, week 8
Primary	Subjective Happiness Scale	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.	Baseline, week 4, week 8
Primary	Connor-Davidson Resilience Scale 10-Item	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.	Baseline, week 4, week 8
Primary	Child-Parent Relationship Scale	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.	Baseline, week 4, week 8
Primary	Family Harmony Scale	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.	Baseline, week 4, week 8