Clinical trial NCT06331936: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen
Official title: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Parent-Child Relations
Happiness
Positive Affect
Keywords: children in need
teenagers from low socioeconomic family
randomized wait-list control trial
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
Collaborators: name: International Social Service Hong Kong Branch
First posted: 2024-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 10-item Emotional Management Strategy Questionnaire
timeFrame: Baseline, week 4, week 8
measure: 10-item Positive and Negative Affect Schedule
timeFrame: Baseline, week 4, week 8
measure: Patient Health Questionnaire-9
timeFrame: Baseline, week 4, week 8
measure: Generalized Anxiety Disorder Scale
timeFrame: Baseline, week 4, week 8
measure: Subjective Happiness Scale
timeFrame: Baseline, week 4, week 8
measure: Connor-Davidson Resilience Scale 10-Item
timeFrame: Baseline, week 4, week 8
measure: Child-Parent Relationship Scale
timeFrame: Baseline, week 4, week 8
measure: Family Harmony Scale
timeFrame: Baseline, week 4, week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: City University of Hong Kong
Study officials:
affiliation: City University of Hong Kong
name: Nancy YU, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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
citation: 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.
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
citation: 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
citation: 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.
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.
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
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.
citation: 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.