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Completed

NCT Number: NCT06331936

Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen

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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City University of Hong Kong

Hong Kong, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotion regulation

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.

Primary outcomes

  1. 10-item Emotional Management Strategy Questionnaire

    Time frame: Baseline, week 4, week 8

    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.

  2. 10-item Positive and Negative Affect Schedule

    Time frame: Baseline, week 4, week 8

    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.

  3. Patient Health Questionnaire-9

    Time frame: Baseline, week 4, week 8

    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.

  4. Generalized Anxiety Disorder Scale

    Time frame: Baseline, week 4, week 8

    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.

  5. Subjective Happiness Scale

    Time frame: Baseline, week 4, week 8

    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.

  6. Connor-Davidson Resilience Scale 10-Item

    Time frame: Baseline, week 4, week 8

    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.

  7. Child-Parent Relationship Scale

    Time frame: Baseline, week 4, week 8

    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.

  8. Family Harmony Scale

    Time frame: Baseline, week 4, week 8

    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.

Sponsors and collaborators

Lead sponsor

City University of Hong Kong

Other

Collaborators

  • International Social Service Hong Kong Branch

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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