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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185273
• Other study ID #: UW16-145
• Status: Completed
• Start date: March 9, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 31, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Development
• Parent-Child Relations

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental PHQ-9-score, DASS Depression and Anxiety subscale score	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.	6 months
Other	Family disharmony measured by FHS-5	The Chinese version of Family Harmony Scale - 5 (FHS-5) will be used to measure family harmony.	6 months
Other	Child physical assault and neglect potential measured by the Physical Assault and Neglect subscale of the CTSPC	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).	6 months
Other	Authoritative parenting style measured by the Authoritative Parenting Style subscale of the PSDQ	Parenting style will be assessed using the Authoritative Parenting Style subscale of the Parenting Style and Dimension Questionnaire (PSDQ).	6 months
Other	Neighbourhood cohesion measured by NCES	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.	6 months
Primary	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	baseline, 6 months, 12 months and 24 months
Secondary	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.	baseline, 6 months, 12 months and 24 months
Secondary	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).	baseline and 24 months
Secondary	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	baseline, 12 months and 24 months
Secondary	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	baseline, 6 months, 12 months and 24 months
Secondary	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.	baseline, 6 months, 12 months and 24 months