Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen

NCT ID: NCT06331936

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-06

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotion Regulation Parent-Child Relations Happiness Positive Affect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

The intervention arm aims at improving children's emotional regulation skills.

Group Type EXPERIMENTAL

Emotion regulation

Intervention Type BEHAVIORAL

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.

Control Arm

The control arm participants will not receive any interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Social Service Hong Kong Branch

UNKNOWN

Sponsor Role collaborator

City University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Nancy Xiaonan Yu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nancy YU, Dr.

Role: PRINCIPAL_INVESTIGATOR

City University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City University of Hong Kong

Hong Kong, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nancy YU, Dr.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nancy Xiaonan YU, Ph.D.

Role: primary

(852)34429436

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18157881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12964174 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26112397 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3397865 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21193179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34093269 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Shenzhen Project

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Jockey Club Support Project
NCT07136064 RECRUITING NA