Emotions Clinical Trial
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
Verified date | July 2022 |
Source | City University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 217 |
Est. completion date | February 17, 2022 |
Est. primary completion date | January 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 60 Years |
Eligibility | For parents: Inclusion Criteria: 1. came to Hong Kong for less than three years (newly arrived only); 2. provide care to at least one cross-boundary child (cross-boundary only); 3. have a child aged between 6-14 4. can participate in the group with the children at the same time; Exclusion Criteria: 1. have a history of severe psychotic symptoms; 2. have previously participated in a similar intervention program. For children: Inclusion Criteria: 1. are 6-14 years of age; 2. have lived in mainland China for more than six months, and commuted daily between mainland China and Hong Kong (cross-boundary only); 3. have been studing in Hong Kong. Exclusion Criteria: 1. have a history of severe psychotic symptoms; 2. have previously participated in a similar intervention program. |
Country | Name | City | State |
---|---|---|---|
China | City University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
City University of Hong Kong | International Social Services Hong Kong Branch |
China,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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