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Child DevelopmentNCT03185273

Parent-child Relationship Among Low-income Families in Hong Kong

An observational study of Child Development and Parent-Child Relations, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective cohort study building upon the existing cohort study on the effectiveness of the Trekkers Family Enhancement Scheme. This study will sample 200 low-income parent-child pairs and follow them up for 24 months with yearly assessment on parental stress and child health using both subjective measures… Read more about this study

Who is it for?
Ages 6 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Child Development, Parent-Child Relations
How many people
217 participants
Where
1 siteHong Kong
Study dates
9 Mar 2016to 31 Jan 2020
Phase
Observational
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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Participants from low-income families will be recruited from the existing cohort study (main cohort study) on the effectiveness of the Trekkers Family Enhancement Scheme funded by a philanthropic foundation in Hong Kong (Kerry Group Kuok Foundation (Hong Kong) Limited).

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: In-depth Exploration of a Bidirectional Parent-child Relationship and Its Mediating and Moderating Factors Among Low-income Families in Hong Kong

This is a prospective cohort study building upon the existing cohort study on the effectiveness of the Trekkers Family Enhancement Scheme. This study will sample 200 low-income parent-child pairs and follow them up for 24 months with yearly assessment on parental stress and child health using both subjective measures and objective physiological parameters. Additional data on parenting style, neighbourhood cohesion, child physical assault and neglect potential, parental mental health and HRQOL and family disharmony will also be collected at each assessment time point for testing mediating and moderating mechanisms between parental stress and child health. The baseline assessment will be carried out in 2016-17 with three repeated assessments after 6 months, 12 months, and 24 months.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Child CHQ General Health Perception subscale score from baseline, 6 months, 12 months to 24 months

    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

    Measured: baseline, 6 months, 12 months and 24 months

Secondary outcomes (5)

  1. Change in Child SDQ Totally Difficulty score from baseline, 6 months, 12 months to 24 months

    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.

    Measured: baseline, 6 months, 12 months and 24 months

  2. Change in Child telomere length from baseline to 24 months

    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).

    Measured: baseline and 24 months

  3. Change in Parental allostatic load index from baseline, 6 months, 12 months to 24 months

    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

    Measured: baseline, 12 months and 24 months

  4. Change in Parental SF-12v2 HRQOL scores from baseline, 6 months, 12 months to 24 months

    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

    Measured: baseline, 6 months, 12 months and 24 months

  5. Change in Parental DASS Stress subscale score from baseline, 6 months, 12 months to 24 months

    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.

    Measured: baseline, 6 months, 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start9 Mar 2016
  3. Primary completion9 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03185273
Sponsor's protocol ID
UW16-145
Status last verified
Mar 2020
First submitted
25 May 2017
Last updated
3 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wong RSM, Yu EYT, Guo VY, Wan EY, Chin WY, Wong CKH, Fung CSC, Tung KTS, Wong WH, Ip P, Tiwari AFY, Lam CLK. A prospective cohort study to investigate parental stress and child health in low-income Chinese families: protocol paper. BMJ Open. 2018 Feb 22;8(2):e018792. doi: 10.1136/bmjopen-2017-018792.

    PubMed 29472262

Questions about this trial

What is this clinical trial studying?

An observational study of Child Development and Parent-Child Relations, run by The University of Hong Kong at 1 site in Hong Kong.

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 2 inclusion and 3 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 3 Mar 2020. 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 Hong Kong. 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 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). 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 NCT03185273, which also lists 1 linked publication.

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 3 Mar 2020.

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