- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185273
Parent-child Relationship Among Low-income Families in Hong Kong
In-depth Exploration of a Bidirectional Parent-child Relationship and Its Mediating and Moderating Factors Among Low-income Families in Hong Kong
Study Overview
Status
Conditions
Detailed Description
Study aims
- To examine the relationship between parental stress and child health.
- To evaluate the stress of parents as indicated by their subjective perception of mental health, quality of life and allostatic load on the body.
- To evaluate the health of children as indicated by their well-being, behaviors, body mass index (BMI) z-score and telomere length.
- To examine the correlation between changes in parental stress and changes in child health over time.
- To identify the moderators and mediators of the relationship between parental stress and child health.
Eligible participants in the main cohort study will be approached by call or during face-to-face sessions. Parents who express interest in participation will be provided with an information sheet about the research and asked to sign the consent form for themselves and for their children. After providing consent, the parent of each parent-child pair will complete a set of structured questionnaires on parental mental health and HRQOL, parenting style, neighborhood cohesion, and their children's well-being and behaviors. Physical examination including blood pressure, heart rate, weight, height, and waist-to-hip ratio will also be carried out on both parents and children. A swab of buccal cells will be taken from each child. Venous blood will be sampled from each parent.
This study will have four assessment waves: Baseline, T2 follow up (6 months), T3 follow up (12 months), and T4 follow up (24 months). Physical health data and biological samples will be collected by research nurses and research assistants during health assessment session held in community centers. Questionnaire data will be collected by trained interviewers during telephone survey. To minimize attrition, a package of questionnaires and a sheet of instructions and equipment (i.e. brushes) for swab-taking at home may also be sent to parents upon request.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Family monthly household income does not exceed 75% of Hong Kong's median monthly household income
- At least one parent and one child aged 6 to 16 years of the same family have given consent to participate in the main cohort study
Exclusion Criteria:
- Parents cannot speak or read Chinese;
- Children were born prematurely and/or with a congenital deformity; and
- Neither parent is the primary caregiver of the child.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child CHQ General Health Perception subscale score from baseline, 6 months, 12 months to 24 months
Time Frame: baseline, 6 months, 12 months and 24 months
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Quality of life: Child Health Questionnaire - Parent Form 50 (CHQ-PF50) is a parent proxy measure of children's physical and psychological wellbeing, with 50 items grouped into 12 multi-item subscales.
Its Chinese version has been shown to have good psychometric properties in local Chinese children
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baseline, 6 months, 12 months and 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child SDQ Totally Difficulty score from baseline, 6 months, 12 months to 24 months
Time Frame: baseline, 6 months, 12 months and 24 months
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Strength and Difficulties Questionnaire (SDQ) is a 25-item parent-completed questionnaire measuring children's behavioral issues.
The SDQ, with 5 subscales, has been translated into traditional Chinese and tested with satisfactory reliability and validity in local children.
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baseline, 6 months, 12 months and 24 months
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Change in Child telomere length from baseline to 24 months
Time Frame: baseline and 24 months
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Telomere length will be measured by the method adapted from that originally published by Cawthon.
For each sample, the telomere length will be represented by the relative ratio of the telomere repeat copy number (T) to the single copy gene 36BA copy number (S).
The T/S ratio will be determined by quantitative polymerase chain reaction (qPcR) using a 7900HT Thermocycler (Applied Biosystems).
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baseline and 24 months
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Change in Parental allostatic load index from baseline, 6 months, 12 months to 24 months
Time Frame: baseline, 12 months and 24 months
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A review of literature has identified a set of physiological parameters that can reflect allostatic load and yet be conveniently measured, including blood pressure, heart rate, body-mass-index, waist-to-hip ratio, lipid profile, fasting glucose and glycosylated haemoglobin.
An index score of allostatic load will be calculated by summing the number of parameters that fall into the "highest" risk quartile defined by local clinical practice guidelines
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baseline, 12 months and 24 months
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Change in Parental SF-12v2 HRQOL scores from baseline, 6 months, 12 months to 24 months
Time Frame: baseline, 6 months, 12 months and 24 months
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The SF-12 Health Survey-Version 2 (SF-12v2) is a 12-item quality of life assessment instrument that covers 8 subscales.
The Chinese version of SF-12v2 has been validated and normed in local Chinese population
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baseline, 6 months, 12 months and 24 months
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Change in Parental DASS Stress subscale score from baseline, 6 months, 12 months to 24 months
Time Frame: baseline, 6 months, 12 months and 24 months
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Depression Anxiety Stress Scale (DASS) has 3 subscales, each with 7 items rating the severity/frequency of symptoms of stress, anxiety and depression respectively.
DASS also has well-established psychometric properties and been validated in Chinese population.
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baseline, 6 months, 12 months and 24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental PHQ-9-score, DASS Depression and Anxiety subscale score
Time Frame: 6 months
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Depression Anxiety Stress Scale (DASS) has 3 subscales, each with 7 items rating the severity/frequency of symptoms of stress, anxiety and depression respectively.
DASS also has well-established psychometric properties and been validated in Chinese population.
In addition, Patient Health Questionnaire - 9 (PHQ-9) will be used to screen for depression in parents.
The Chinese version of PHQ-9 has been validated and used in previous local studies.
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6 months
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Family disharmony measured by FHS-5
Time Frame: 6 months
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The Chinese version of Family Harmony Scale - 5 (FHS-5) will be used to measure family harmony.
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6 months
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Child physical assault and neglect potential measured by the Physical Assault and Neglect subscale of the CTSPC
Time Frame: 6 months
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Parental risk of physically abusing and neglecting children will also be assessed with the Child Physical Assault and Neglect subscale of the Parent Child Conflict Tactics Scale (CTSPC).
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6 months
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Authoritative parenting style measured by the Authoritative Parenting Style subscale of the PSDQ
Time Frame: 6 months
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Parenting style will be assessed using the Authoritative Parenting Style subscale of the Parenting Style and Dimension Questionnaire (PSDQ).
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6 months
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Neighbourhood cohesion measured by NCES
Time Frame: 6 months
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The Chinese version of Neighborhood Collective Efficacy Scale (NCES) is a 10-item scale, with five items each on informal social control and social cohesion.
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW16-145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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