Project KING: To Strengthen Parent-child Relationship and Adaptation

Study Overview
=================
Brief 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. 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).

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

Conditions
-----------------
Emotions, Family Conflict, Adaptation

Intervention / Treatment
-----------------
* Behavioral: Emotion regulation
* Behavioral: Information provision


Participation Criteria
=================
Eligibility Criteria
-----------------
For parents: Inclusion Criteria: 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; Exclusion Criteria: have a history of severe psychotic symptoms; have previously participated in a similar intervention program. For children: Inclusion Criteria: 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. Exclusion Criteria: have a history of severe psychotic symptoms; have previously participated in a similar intervention program.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion regulation arm<br>The emotion regulation arm aims at improving emotional regulation skills among parents and children. | Behavioral: Emotion regulation<br>* 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.<br>|
| Active Comparator: Information provision arm<br>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. | Behavioral: Information provision<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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. | 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. | 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. | Baseline, week 4, and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, week 4, and week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
new immigrants, cross-boundary family, parallel group intervention