EmotionsNCT04917822
Project KING: To Strengthen Parent-child Relationship and Adaptation
A study testing Emotion regulation and Information provision in people with Emotions and Family Conflict, run by City University of Hong Kong at 1 site in China.
Trial summary
This study aims at improving the emotional regulation strategies, enhancing the parent-child relationship and preventing family conflict among newly arrived and cross-boundary families in Hong Kong. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions, Family Conflict, Adaptation
- What is being tested?
- Emotion regulation and Information provision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- came to Hong Kong for less than three years (newly arrived only);
- provide care to at least one cross-boundary child (cross-boundary only);
- have a child aged between 6-14
- can participate in the group with the children at the same time;
- are 6-14 years of age;
- have lived in mainland China for more than six months, and commuted daily between mainland China and Hong Kong (cross-boundary only);
- have been studing in Hong Kong.
Who cannot join
- have a history of severe psychotic symptoms;
- have previously participated in a similar intervention program.
- For children:
- have a history of severe psychotic symptoms;
- have previously participated in a similar intervention program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project KING: A Randomized Controlled Trial of Parallel Group Interventions to Strengthen Parent-child Relationship and Adaptation in Newly Arrived and Cross-boundary Families
This study aims at improving the emotional regulation strategies, enhancing the parent-child relationship and preventing family conflict among newly arrived and cross-boundary families in Hong Kong. We will provide one of the interventions to the participants: (a) the emotion regulation arm, which aimed at improving the emotion management skill for parent and child; or (b) the information provision arm, which aimed at providing information about Hong Kong, such as education, community resources, medical care, employment, housing, and job-seeking. We aim to recruit 200 parent-child pairs to participate in the study. The participants will be randomly assigned into an emotion regulation arm or an information provision arm. The ratio of the two arms is 3:2. Specifically, 120 and 80 parent-child pairs will be assigned to the emotion regulation arm and the information provision arm, respectively. The two intervention arms will provide four 2-hour weekly sessions to the participants. Before the intervention (T1), immediately after the intervention (T2), and one month after completing the intervention (T3), the participants will finish the assessments to evaluate the effectiveness of the intervention.
Read the detailed description
- Context of the study About 123 people migrate from Mainland China to Hong Kong to reunite with family every day. Migration from Mainland China to Hong Kong can be highly stressful. Newly arrived mothers and their children experience adaptation-related stressors, such as lifestyle changes, unhealthy housing conditions, and family financial restrictions, and they tend to experience high levels of psychological distress. Among the migrant population in Hong Kong, a particular group is known as cross-boundary children who engage in everyday-migration. Most cross-boundary children live in Shenzhen with their parents, who are not Hong Kong citizens. To attend school in Hong Kong, these children have to cross the border checkpoints connecting Hong Kong with mainland China every day. Families with cross-boundary children experience adaptation-related stressors, such as language difficulties, economic burden, and unclear citizenship status. These families have weaker social support networks in Shenzhen and seldom use community services in Hong Kong. Thus, cross-boundary families face multiple challenges and stressors due to their situation, which also puts them at a high risk of mental health problems.
- Target of emotion regulation Newly arrived and cross-boundary families face similar problems, such as discrimination, acculturative stress, mental health problems (e.g., depression). All these problems can result in family conflict between parents and child. For example, early interviews have revealed that conflict over schoolwork and academic performance between children and parents could threaten overall family harmony. Frustrated with their lack of emotion regulation strategies, the children and parents often vented their anger and anxiety on each other, which sometimes led to physical abuse. Previous studies have demonstrated that the identification, comprehension, expression, regulation, and use of emotions are important predictors of individual adaptation and are positively correlated with mental health (e.g., happiness and social functioning). Parents' emotional regulation and mental health can influence their children's emotional socialization by means of diffusion through the family emotional climate. Thus, a community-based intervention focused on emotion regulation might help decrease these conflicts and enhance family harmony.
- Cultural and contextual considerations in the intervention feature Family system theory states that families function as interdependent individual systems in which each member can impact others. It has been found that children's emotional problems are related to the stressful experiences and emotional symptoms of their parents. Therefore, we involved both parents and children concurrently in the intervention to maximize the intervention benefits. The parallel-group model is widely advocated in family-based intervention, but its implementation has a certain degree of difficulty. A parallel-group comprises two concurrent, but separate intervention groups (e.g., a child group together with a parent group); participants from the two groups engage in similar activities in different rooms with corresponding goals and contents. Compared with an intervention for individuals alone, involving family members in a family-based intervention can lead to greater benefits. Separating parents from children could prevent children from their parents' over-control and let each group deal with their own problems. The parallel-group model has been used to deal with different problems in parents and children. For example, a parent-child parallel-group helped improve the psychological functioning of depressed mothers, the mothers' caregivers, and children in Latino immigrant families. Therefore, the parent-child parallel group is considered an appropriate format for addressing the needs of cross-boundary families Two intervention studies evaluated the effectiveness of emotional regulation strategies on the parent-child relationship. The parental emotional management program increased emotional management strategy during the parent-child interaction, positive affect, subjective happiness, satisfaction with the parent-child relationship, and family harmony and decreased negative emotion among mothers of 6-8 years child in Hong Kong. However, this study did not include children in the intervention. A parent-child parallel emotional regulation group intervention improved the positive affect, resilience, and family harmony and reduced depressive symptoms among both parents and children. However, this study did not include the control group and had a small sample size. In sum, the present study aims to test the effectiveness of an emotion regulation parallel-group intervention on strengthening parent-child relationship and adaptation in newly arrived and cross-boundary families in Hong Kong.
- Procedure We aim to recruit 200 parent-child pairs to participate in the study. The participants will be randomly assigned into one of the following arms: a) the relationship enhancement arm, which aims at improving emotional regulation skills among parent and child; b) the information provision arm, which aims at providing information about Hong Kong, such as education, community resources, medical care, employment, housing, and job-seeking. The ratio of the two arms is 3:2. Specifically, 120 and 80 parent-child pairs will be assigned to the relationship enhancement arm or the information provision arm, respectively. The two intervention arms will provide four 2-hour weekly sessions to the participants. The participants will finish the assessments at baseline (T1), immediately after the intervention (T2), and one month after completing the intervention (T3).
- Conditions
- Emotions, Family Conflict, Adaptation
- Being tested
- Emotion regulation, Information provision
- Keywords
- new immigrants, cross-boundary family, parallel group intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion regulationBehavioural
Emotion regulation arm will provide the parents and children with four 2-hour weekly sessions. For the parents, the main topics include raising awareness of emotions (e.g., learning emotions theories), developing skills to manage emotions (e.g., attention deployment, cognitive changes, response modification), and facilitating parent-child relationship (e.g., gratitude). For children, the main topics are similar to that in parents' intervention. In this arm, we give more specific examples and simple explanations to the children.
Information provisionBehavioural
Information provision arm will provide the parents and children with four 2-hour weekly sessions. For the parents, the main topics in these four sessions include learning the general information about Hong Kong such as education and medical care, housing condition, employment and training. For children, the main topics include learning the general information about Hong Kong, such as education, community facility, and learning method.
| Study group | Role | What they receive |
|---|---|---|
| Emotion regulation arm | Experimental | The emotion regulation arm aims at improving emotional regulation skills among parents and children. Receives: Behavioral: Emotion regulation |
| Information provision arm | Active comparator | The information provision arm aims at providing information about Hong Kong, such as education, community resources, medical care, employment, housing, and job-seeking among parents and children. Receives: Behavioral: Information provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Emotional Management Strategy Questionnaire to Week 4 and to Week 8
Emotional management strategy questionnaire is a 10-item scale assessing parents' and children's emotional management strategy. Possible scores range from 1 (not at all) to 6 (everyday). Higher scores indicate more frequent use of emotional management strategy.
Measured: Baseline, week 4, and week 8
Change from Baseline in Positive and Negative Affect Schedule to Week 4 and to Week 8
Positive and negative affect schedule is a 10-item scale assessing parents' and children's positive and negative affect. Possible scores range from 1 (not at all) to 6 (everyday). Higher scores indicate more positive or negative affect.
Measured: Baseline, week 4, and week 8
Change from Baseline in Subjective Happiness Scale to Week 4 and to Week 8
Subjective happiness scale is a 4-item scale assessing parents' and children's subjective happiness. Possible scores range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate more subjective happiness.
Measured: Baseline, week 4, and week 8
Change from Baseline in Child-Parent Relationship Scale (Pianta) to Week 4 and to Week 8
Child-parent relationship scale is a 4-item scale assessing the relationship between parents and children. Possible scores range from 1 (very dissatisfied) to 6 (very satisfied). Higher scores indicate better satisfaction with parents (or child).
Measured: Baseline, week 4, and week 8
Change from Baseline in Family Harmony Scale to Week 4 and to Week 8
Family harmony scale is a 8-item scale assessing the family harmony. Possible scores range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate better family harmony.
Measured: Baseline, week 4, and week 8
Change from Baseline in Adaptation Difficulties to Week 4 and to Week 8
Adaptation difficulties is a 24-item scale assessing the adaptation difficulties after parents and children come to Hong Kong. Possible scores range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate greater adaptation difficulties.
Measured: Baseline, week 4, and week 8
Change from Baseline in Self-developed Knowledge Questionnaire to Week 4 and to Week 8
Knowledge questionnaire is a 18-item scale assessing how much parents and children know about Hong Kong (e.g., educaltional systems, community sevices). Possible scores include1 (right), 2 (wrong), and 3(don't know). Higher scores indicate greater knowledge about Hong Kong.
Measured: Baseline, week 4, and week 8
Secondary outcomes (8)
Change from Baseline in Generalized Anxiety Disorder Questionnaire-7 to Week 4 and to Week 8
Generalized anxiety disorder questionnaire assesses the anxiety symptoms among parents and children. Higher scores indicate more anxiety symptoms.
Measured: Baseline, week 4, and week 8
Change from Baseline in The Patient Health Questionnaire-9 to Week 4 and to Week 8
Patient health questionnaire assesses the depressive symptoms among parents and children. Higher scores indicate more depressive symptoms.
Measured: Baseline, week 4, and week 8
Change from Baseline in Mental Health Inventory-5 to Week 4 and to Week 8
Mental health inventory assesses the mental health among parents and children. Higher scores indicate better mental health.
Measured: Baseline, week 4, and week 8
Change from Baseline in 10-item Connor-Davidson Resilience Scale to Week 4 and to Week 8
Connor-Davidson resilience scale assesses the individual resilience among parents and children. Higher scores indicate greater resilience.
Measured: Baseline, week 4, and week 8
Change from Baseline in Childhood Trauma Questionnaire to Week 4 and to Week 8
Childhood trauma questionnaire whether parents spank their children. Higher scores indicate less physical abuse on children.
Measured: Baseline, week 4, and week 8
Change from Baseline in Child-Parent Relationship Scale (Driscoll & Pianta) to Week 4 and to Week 8
Child-parent relationship scale has two subscales assessesing the closeness and conflict between parents and children, respectively. Higher scores indicate greater closeness or greater conflict between parents and children.
Measured: Baseline, week 4, and week 8
Change from Baseline in Self-Developed Service Use Questionnaire to Week 4 and to Week 8
Self-developed service use questionnaire is a 14-item scale assessing whether parents and children use the social service in Hong Kong. Higher scores indicate more use of social service.
Measured: Baseline, week 4, and week 8
Change from Baseline in Self-Developed Capacity Questionnaire to Week 4 and to Week 8
Self-developed capacity questionnaire is a 11-item scale assessing whether parents and children have the capacity to use the social service in Hong Kong. Higher scores indicate greater capacity to use the social service.
Measured: Baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 Apr 2021
- Primary completion28 Jan 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for EmotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both parents and children will be included in the intervention. The research team will conduct parallel intevention to parents and children in separate groups at the same time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- International Social Services Hong Kong Branch
- Responsible party
- Principal investigator, Dr. Nancy Xiaonan Yu, City University of Hong Kong
- Investigators
- Nancy YU, Dr., Principal investigator, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917822
- Sponsor's protocol ID
- Project KING
- Status last verified
- Jul 2022
- First submitted
- 12 Apr 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not make individual participant data available to other researchers.
Publications
Berwick DM, Murphy JM, Goldman PA, Ware JE Jr, Barsky AJ, Weinstein MC. Performance of a five-item mental health screening test. Med Care. 1991 Feb;29(2):169-76. doi: 10.1097/00005650-199102000-00008.
PubMed 1994148Brasseur S, Gregoire J, Bourdu R, Mikolajczak M. The Profile of Emotional Competence (PEC): development and validation of a self-reported measure that fits dimensions of emotional competence theory. PLoS One. 2013 May 6;8(5):e62635. doi: 10.1371/journal.pone.0062635. Print 2013.
PubMed 23671616Campbell-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.
PubMed 18157881Chan, A. K.-W., & Ngan, L. L.-S. (2018). Investigating the differential mobility experiences of Chinese cross-border students. Mobilities, 13(1), 142-156. https://doi.org/10.1080/17450101.2017.1300452
Chan, K. L., Yeung, K. C., Chu, C. K., Tsang, K. Y., & Leung, Y. K. (2002). An evaluative study on the effectiveness of a parent-child parallel group model. Research on Social Work Practice, 12(4), 546-557. https://doi.org/10.1177/1049731502012004006
Chan, P. W. K., & Kabir, A. H. (2014). Education across borders in Hong Kong. In H. Zhang, P. W. K. Chan, & C. Boyle (Eds.), Equality in education: Fairness and inclusion (pp. 155-166). Brill Sense. https://doi.org/10.1007/978-94-6209-692-9_12
Dowell KA, Ogles BM. The effects of parent participation on child psychotherapy outcome: a meta-analytic review. J Clin Child Adolesc Psychol. 2010;39(2):151-62. doi: 10.1080/15374410903532585.
PubMed 20390807Driscoll, K., & Pianta, R. C. (2011). Mothers' and Fathers' Perceptions of Conflict and Closeness in Parent-Child Relationships during Early Childhood. Journal of Early Childhood & Infant Psychology.
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.
PubMed 26112397Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lyubomirsky, S., & Lepper, H. S. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46(2), 137-155.
Morris AS, Silk JS, Steinberg L, Myers SS, Robinson LR. The Role of the Family Context in the Development of Emotion Regulation. Soc Dev. 2007 May 1;16(2):361-388. doi: 10.1111/j.1467-9507.2007.00389.x.
PubMed 19756175Pianta, R. C. (1992). Child-parent relationship scale. Unpublished measure, University of Virginia, 11, 39-41.
Qu D, Chen C, Kouros CD, Yu NX. Congruence and discrepancy in migrant children's and mothers' perceived discrimination: Using response surface analysis to examine the effects on psychological distress. Appl Psychol Health Well Being. 2021 Aug;13(3):602-619. doi: 10.1111/aphw.12249. Epub 2021 Feb 7.
PubMed 33554475Spitzer 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.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project KING: A Randomized Controlled Trial of Parallel Group Interventions to Strengthen Parent-child Relationship and Adaptation in Newly Arrived and Cross-boundary Families
- ClinicalTrials.gov ID
- NCT04917822
- Acronym / sponsor ID
- Project KING
- Conditions
- Emotions, Family Conflict, Adaptation
- Keywords
- new immigrants, cross-boundary family, parallel group intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Collaborators
- International Social Services Hong Kong Branch
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at improving the emotional regulation strategies, enhancing the parent-child relationship and preventing family conflict among newly arrived and cross-boundary families in Hong Kong. We will provide one of the interventions to the participants: (a) the emotion regulation arm, which aimed at improving the emotion management skill for parent and child; or (b) the information provision arm, which aimed at providing information about Hong Kong, such as education, community resources, medical care, employment, housing, and job-seeking. We aim to recruit 200 parent-child pairs to participate in the study. The participants will be randomly assigned into an emotion regulation arm or an information provision arm. The ratio of the two arms is 3:2. Specifically, 120 and 80 parent-child pairs will be assigned to the emotion regulation arm and the information provision arm, respectively. The two intervention arms will provide four 2-hour weekly sessions to the participants. Before the intervention (T1), immediately after the intervention (T2), and one month after completing the intervention (T3), the participants will finish the assessments to evaluate the effectiveness of the intervention.
Detailed description
- Context of the study About 123 people migrate from Mainland China to Hong Kong to reunite with family every day. Migration from Mainland China to Hong Kong can be highly stressful. Newly arrived mothers and their children experience adaptation-related stressors, such as lifestyle changes, unhealthy housing conditions, and family financial restrictions, and they tend to experience high levels of psychological distress. Among the migrant population in Hong Kong, a particular group is known as cross-boundary children who engage in everyday-migration. Most cross-boundary children live in Shenzhen with their parents, who are not Hong Kong citizens. To attend school in Hong Kong, these children have to cross the border checkpoints connecting Hong Kong with mainland China every day. Families with cross-boundary children experience adaptation-related stressors, such as language difficulties, economic burden, and unclear citizenship status. These families have weaker social support networks in Shenzhen and seldom use community services in Hong Kong. Thus, cross-boundary families face multiple challenges and stressors due to their situation, which also puts them at a high risk of mental health problems.
- Target of emotion regulation Newly arrived and cross-boundary families face similar problems, such as discrimination, acculturative stress, mental health problems (e.g., depression). All these problems can result in family conflict between parents and child. For example, early interviews have revealed that conflict over schoolwork and academic performance between children and parents could threaten overall family harmony. Frustrated with their lack of emotion regulation strategies, the children and parents often vented their anger and anxiety on each other, which sometimes led to physical abuse. Previous studies have demonstrated that the identification, comprehension, expression, regulation, and use of emotions are important predictors of individual adaptation and are positively correlated with mental health (e.g., happiness and social functioning). Parents' emotional regulation and mental health can influence their children's emotional socialization by means of diffusion through the family emotional climate. Thus, a community-based intervention focused on emotion regulation might help decrease these conflicts and enhance family harmony.
- Cultural and contextual considerations in the intervention feature Family system theory states that families function as interdependent individual systems in which each member can impact others. It has been found that children's emotional problems are related to the stressful experiences and emotional symptoms of their parents. Therefore, we involved both parents and children concurrently in the intervention to maximize the intervention benefits. The parallel-group model is widely advocated in family-based intervention, but its implementation has a certain degree of difficulty. A parallel-group comprises two concurrent, but separate intervention groups (e.g., a child group together with a parent group); participants from the two groups engage in similar activities in different rooms with corresponding goals and contents. Compared with an intervention for individuals alone, involving family members in a family-based intervention can lead to greater benefits. Separating parents from children could prevent children from their parents' over-control and let each group deal with their own problems. The parallel-group model has been used to deal with different problems in parents and children. For example, a parent-child parallel-group helped improve the psychological functioning of depressed mothers, the mothers' caregivers, and children in Latino immigrant families. Therefore, the parent-child parallel group is considered an appropriate format for addressing the needs of cross-boundary families Two intervention studies evaluated the effectiveness of emotional regulation strategies on the parent-child relationship. The parental emotional management program increased emotional management strategy during the parent-child interaction, positive affect, subjective happiness, satisfaction with the parent-child relationship, and family harmony and decreased negative emotion among mothers of 6-8 years child in Hong Kong. However, this study did not include children in the intervention. A parent-child parallel emotional regulation group intervention improved the positive affect, resilience, and family harmony and reduced depressive symptoms among both parents and children. However, this study did not include the control group and had a small sample size. In sum, the present study aims to test the effectiveness of an emotion regulation parallel-group intervention on strengthening parent-child relationship and adaptation in newly arrived and cross-boundary families in Hong Kong.
- Procedure We aim to recruit 200 parent-child pairs to participate in the study. The participants will be randomly assigned into one of the following arms: a) the relationship enhancement arm, which aims at improving emotional regulation skills among parent and child; b) the information provision arm, which aims at providing information about Hong Kong, such as education, community resources, medical care, employment, housing, and job-seeking. The ratio of the two arms is 3:2. Specifically, 120 and 80 parent-child pairs will be assigned to the relationship enhancement arm or the information provision arm, respectively. The two intervention arms will provide four 2-hour weekly sessions to the participants. The participants will finish the assessments at baseline (T1), immediately after the intervention (T2), and one month after completing the intervention (T3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both parents and children will be included in the intervention. The research team will conduct parallel intevention to parents and children in separate groups at the same time.
| Arm | Type | Receives |
|---|---|---|
| Emotion regulation arm | Experimental | Behavioral: Emotion regulationThe emotion regulation arm aims at improving emotional regulation skills among parents and children. |
| Information provision arm | Active comparator | Behavioral: Information provisionThe information provision arm aims at providing information about Hong Kong, such as education, community resources, medical care, employment, housing, and job-seeking among parents and children. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- came to Hong Kong for less than three years (newly arrived only);
- provide care to at least one cross-boundary child (cross-boundary only);
- have a child aged between 6-14
- can participate in the group with the children at the same time;
- are 6-14 years of age;
Key exclusion criteria (5 listed)
- have a history of severe psychotic symptoms;
- have previously participated in a similar intervention program.
- have a history of severe psychotic symptoms;
- have previously participated in a similar intervention program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion regulationEmotion regulation arm will provide the parents and children with four 2-hour weekly sessions. For the parents, the main topics include raising awareness of emotions (e.g., learning emotions theories), developing skills to manage emotions (e.g., attention deployment, cognitive changes, response modification), and facilitating parent-child relationship (e.g., gratitude). For children, the main topics are similar to that in parents' intervention. In this arm, we give more specific examples and simple explanations to the children. | Behavioural | Emotion regulation arm |
| Information provisionInformation provision arm will provide the parents and children with four 2-hour weekly sessions. For the parents, the main topics in these four sessions include learning the general information about Hong Kong such as education and medical care, housing condition, employment and training. For children, the main topics include learning the general information about Hong Kong, such as education, community facility, and learning method. | Behavioural | Information provision arm |
Primary outcome
Change from Baseline in Emotional Management Strategy Questionnaire to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Emotional management strategy questionnaire is a 10-item scale assessing parents' and children's emotional management strategy. Possible scores range from 1 (not at all) to 6 (everyday). Higher scores indicate more frequent use of emotional management strategy.
Change from Baseline in Positive and Negative Affect Schedule to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Positive and negative affect schedule is a 10-item scale assessing parents' and children's positive and negative affect. Possible scores range from 1 (not at all) to 6 (everyday). Higher scores indicate more positive or negative affect.
Change from Baseline in Subjective Happiness Scale to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Subjective happiness scale is a 4-item scale assessing parents' and children's subjective happiness. Possible scores range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate more subjective happiness.
Change from Baseline in Child-Parent Relationship Scale (Pianta) to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Child-parent relationship scale is a 4-item scale assessing the relationship between parents and children. Possible scores range from 1 (very dissatisfied) to 6 (very satisfied). Higher scores indicate better satisfaction with parents (or child).
Change from Baseline in Family Harmony Scale to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Family harmony scale is a 8-item scale assessing the family harmony. Possible scores range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate better family harmony.
Change from Baseline in Adaptation Difficulties to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Adaptation difficulties is a 24-item scale assessing the adaptation difficulties after parents and children come to Hong Kong. Possible scores range from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate greater adaptation difficulties.
Change from Baseline in Self-developed Knowledge Questionnaire to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Knowledge questionnaire is a 18-item scale assessing how much parents and children know about Hong Kong (e.g., educaltional systems, community sevices). Possible scores include1 (right), 2 (wrong), and 3(don't know). Higher scores indicate greater knowledge about Hong Kong.
8 secondary outcomes
Change from Baseline in Generalized Anxiety Disorder Questionnaire-7 to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in The Patient Health Questionnaire-9 to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in Mental Health Inventory-5 to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in 10-item Connor-Davidson Resilience Scale to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in Childhood Trauma Questionnaire to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in Child-Parent Relationship Scale (Driscoll & Pianta) to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in Self-Developed Service Use Questionnaire to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Change from Baseline in Self-Developed Capacity Questionnaire to Week 4 and to Week 8
Time frame: Baseline, week 4, and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 1994148Berwick DM, Murphy JM, Goldman PA, Ware JE Jr, Barsky AJ, Weinstein MC. Performance of a five-item mental health screening test. Med Care. 1991 Feb;29(2):169-76. doi: 10.1097/00005650-199102000-00008.
- Background: PubMed 23671616Brasseur S, Gregoire J, Bourdu R, Mikolajczak M. The Profile of Emotional Competence (PEC): development and validation of a self-reported measure that fits dimensions of emotional competence theory. PLoS One. 2013 May 6;8(5):e62635. doi: 10.1371/journal.pone.0062635. Print 2013.
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- Home Affairs Department and Immigration Department statistics on new arrivals from the Mainland (Fourth quarter of 2019).Link provided by the sponsor.
- Home Affairs Department and Immigration Department statistics on new arrivals from the Mainland (First quarter of 2020).Link provided by the sponsor.
- Individual participant dataSharing planned: No. We will not make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy YU, Dr. principal investigator
City University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion regulation and Information provision in people with Emotions and Family Conflict, run by City University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Emotional Management Strategy Questionnaire to Week 4 and to Week 8 (time frame: Baseline, week 4, and week 8). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917822, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.