The University of Hong Kong
Hong Kong
NCT Number: NCT03185273
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.
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Notify Me6 year–16 year
All sexes
Observational
Hong Kong
Study aims
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline, 6 months, 12 months and 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
Time frame: baseline, 6 months, 12 months and 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.
Time frame: baseline and 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).
Time frame: baseline, 12 months and 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
Time frame: baseline, 6 months, 12 months and 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
Time frame: baseline, 6 months, 12 months and 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.
Time frame: 6 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. 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.
Time frame: 6 months
The Chinese version of Family Harmony Scale - 5 (FHS-5) will be used to measure family harmony.
Time frame: 6 months
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).
Time frame: 6 months
Parenting style will be assessed using the Authoritative Parenting Style subscale of the Parenting Style and Dimension Questionnaire (PSDQ).
Time frame: 6 months
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.
The University of Hong Kong
Other
In-depth Exploration of a Bidirectional Parent-child Relationship and Its Mediating and Moderating Factors Among Low-income Families in Hong Kong
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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