NCT04917822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

April 12, 2021

Last Update Submit

July 19, 2022

Conditions

Keywords

new immigrantscross-boundary familyparallel group intervention

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (8)

  • Change from Baseline in Generalized Anxiety Disorder Questionnaire-7 to Week 4 and to Week 8

    Baseline, week 4, and week 8

  • Change from Baseline in The Patient Health Questionnaire-9 to Week 4 and to Week 8

    Baseline, week 4, and week 8

  • Change from Baseline in Mental Health Inventory-5 to Week 4 and to Week 8

    Baseline, week 4, and week 8

  • Change from Baseline in 10-item Connor-Davidson Resilience Scale to Week 4 and to Week 8

    Baseline, week 4, and week 8

  • Change from Baseline in Childhood Trauma Questionnaire to Week 4 and to Week 8

    Baseline, week 4, and week 8

  • +3 more secondary outcomes

Study Arms (2)

Emotion regulation arm

EXPERIMENTAL

The emotion regulation arm aims at improving emotional regulation skills among parents and children.

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.

Behavioral: Information provision

Interventions

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.

Emotion regulation arm

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.

Information provision arm

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • have a history of severe psychotic symptoms;
  • have previously participated in a similar intervention program.
  • For children:
  • 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.
  • have a history of severe psychotic symptoms;
  • have previously participated in a similar intervention program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University of Hong Kong

Hong Kong, China

Location

Related Publications (25)

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    BACKGROUND
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    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 20390807BACKGROUND
  • Driscoll, 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.

    BACKGROUND
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    PMID: 26112397BACKGROUND
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    PMID: 11556941BACKGROUND
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    BACKGROUND
  • 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.

    PMID: 19756175BACKGROUND
  • Pianta, R. C. (1992). Child-parent relationship scale. Unpublished measure, University of Virginia, 11, 39-41.

    BACKGROUND
  • 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.

    PMID: 33554475BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
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    PMID: 24033238BACKGROUND
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    BACKGROUND
  • 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.

    PMID: 3397865BACKGROUND
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    PMID: 17265137BACKGROUND
  • Yu, N. X., Liu, I. K., & Bu, H. (2020). Enhancing resilience in cross-boundary families: A parent-child parallel group intervention. Journal of Social Work. https://doi.org/10.1177/1468017320919103

    BACKGROUND
  • Yu X, Stewart SM, Liu IK, Lam TH. Resilience and depressive symptoms in mainland Chinese immigrants to Hong Kong. Soc Psychiatry Psychiatr Epidemiol. 2014 Feb;49(2):241-9. doi: 10.1007/s00127-013-0733-8. Epub 2013 Jul 2.

    PMID: 23818045BACKGROUND
  • Zhao, X., Zhang, Y., Longfei, L., & Zhou, Y. (2005). Evaluation on reliability and validity of Chinese version of childhood trauma questionnaire. Chinese Journal of Tissue Engineering Research, 9(16), 209-211.

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  • Hu J, Bu H, Liu IKF, Yu NX. A Randomized Controlled Trial of Two Parent-Child Parallel Interventions to Enhance Positive Adaptation of Immigrant Families in Hong Kong: The Moderating Role of Depressive Symptoms. Behav Ther. 2024 Sep;55(5):1026-1042. doi: 10.1016/j.beth.2024.03.001. Epub 2024 Mar 20.

Related Links

Study Officials

  • Nancy YU, Dr.

    City University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
At the recruitment phase, the participants and the social workers who lead the intervention group will not know which intervention 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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2021

First Posted

June 8, 2021

Study Start

April 10, 2021

Primary Completion

January 28, 2022

Study Completion

February 17, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

We will not make individual participant data available to other researchers.

Locations