Condition category
Not Applicable
Date applied
13/06/2016
Date assigned
21/07/2016
Last edited
26/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Healthy Start Home Visit Program has been developed to promote the health of preschool children. It does this by helping school teachers and parents work together on a program offering ways to improve child health (focusing on nutrition, activities, safety in the home and dental health), learning (for example, reading), child behaviour and parenting skills. This study aims to adapt this program into a school-based parent training program, to empower pre-primary parents with parenting needs to effectively promote healthy life styles for their pre-primary children.

Who can participate?
Parents identified as having parenting needs and their children.

What does the study involve?
The schools taking part in the study are randomly allocated to one of two groups. Those in group 1 (the control group) carry on as usual. Those in group 2 (intervention group) undergo the Healthy Start Home Visit Program. The program is delivered through school-based parent training programs, with parent ambassadors (PA) as assistants. The program first facilitates PAs to develop skills and knowledge in enhancing children’s healthy life styles. This is followed by the training so-called Healthy Start Parents (HSP) HSPs are parents that are in need of support (have parenting needs) and have children who are attending pre-primary institutions. Priority is given for disadvantaged families. Each institution has 1 school representative, either teacher or school social worker, to participate in the PA training and assist in HSP school-based program. Assessments take place before the start of the program, after the program completes and then six months later. These include for example, tests of parenting stress and how supported they feel, child behaviour, and child learning.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Twenty pre-primary institutions, Hong Kong.

When is the study starting and how long is it expected to run for?
July 2016 to August 2017

Who is funding the study?
Quality Education Fund (Hong Kong)

Who is the main contact?
1. Ms Yin Kwan Heung (public)
2. Ms Cynthia Leung (scientific)

Trial website

Contact information

Type

Public

Primary contact

Ms Yin Kwan Heung

ORCID ID

Contact details

2/F
Tseng choi Street Government Complex
27 Tseng Choi Street
Tuen Mun
N.T.
Hong Kong
852
China

Type

Scientific

Additional contact

Ms Cynthia Leung

ORCID ID

http://orcid.org/0000-0002-6070-8794

Contact details

Department of Applied Social Sciences
The Hong Kong Polytechnic University.
Hong Kong
852
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EDB/QEF 22/17/14

Study information

Scientific title

Evaluation of Healthy Start Home Visit Program - school-based approach in disadvantaged families

Acronym

HSHVP

Study hypothesis

The Healthy Start Home Visit Program (HSHVP)- School Approach can enhance parents' competence and confidence in promoting their pre-school children's development in physical, cognitive and psychosocial aspects.

Ethics approval

Human Subjects Ethics Sub-Committee of the Hong Kong Polytechnic University, 02/06/2016

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

See additional files

Condition

Assessment includes pre and post intervention and follow-up tests of parenting stress, parent general efficacy, parent perceived social support, child behaviour, and child learning, parent feeding practice, oral health practice. Moreover, sense of efficacy for school representatives, either school teachers or social workers, will also be assessed.

Intervention

Schools are randomly assigned to one of two groups - the intervention group and the control group (business as usual)

The intervention includes 2 parts:

Part I: intensive parent ambassador (PA) training -it aims to facilitate PAs to develop skills and knowledge in helping parents enhance children’s healthy life styles, in physical, cognitive and psychosocial aspects.

Part II: Healthy Start Parent (HSP) school-based program - Provide training to 200 parents through 12 taught sessions, 2 revision sessions and 3 joint-school talks. The parent training will be conducted by project workers and an educational psychologist, assisted by PAs who completed the training in Part I. The content of the program includes the following domains:
1. Psychosocial areas - parent-child relationship, praise, reward, increasing positive behaviours, decreasing inappropriate behaviours
2. Cognitive areas – reading and language skills, preschool concepts
3. Physical areas – nutrition, physical exercises, learning through play (conducted in talks) and home safety (by one-off home visit or individual consultation)
4. Each 2 hour taught session will include feedback on the activities the week before, teaching of each protocol session, role play to practise working on the worksheets and activities and conclusion
5. Revision sessions - 2 hands-on practice sessions will be held to enhance HSP’s skills in establishing child relationship and reading

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Both parent ambassadors and Healthy Start Parents' outcomes will be measured:

Part I. The PAs will be assessed using standardized questionnaires both before and after training, and after delivery of the Healthy Start Parent training program, to examine the changes in:
1. Parenting stress (Parenting Stress Index)
2. Parent general efficacy (GSE)
3. Parent perceived social support (Duke-UNC Functional Social Support Questionnaire)
4. Child behaviour (Eyberg Child Behaviour Inventory)

Part II. Assessment for HSPs includes pre and post HSP training and follow-up tests of:
1. Parenting stress (Parenting Stress Index)
2. Parent general efficacy (GSE)
3. Parent perceived social support (Duke-UNC Functional Social Support Questionnaire)
4. Child behaviour (Eyberg Child Behavior Inventory)
5. Child learning
6. Parent feeding practice
7. Oral health practice

The above tests will be administered before (pre) and after program completion (post) and 6 months after program completion (follow-up)

Secondary outcome measures

1. Co-working school teachers/ social workers' efficacy before PA training and after HSP school-based program, using the questionnaire adapted from Teachers’ Sense of Efficacy Scale – short form
2. Parent participation in school activities, parent-teacher meetings and parent practice of exercises at home, assessed using a log that will be kept for those participating in the program
3. Parents views in relation to the program materials, activities and delivery format, collected through focus groups

Overall trial start date

01/07/2016

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

The PA and HSP must meet the following criteria:
1. The participating parent show parenting needs
2. Can read Chinese and have children who are attending pre-primary institutions
3. The parent and the children should normally reside in Hong Kong

Priorities are given to HSPs from disadvantaged families, including single-parent families, Mainland new arrivals and low-income families.

Participant type

Other

Age group

Other

Gender

Both

Target number of participants

200 parents will be recruited from 20 pre-primary institutions

Participant exclusion criteria

1. Parents with children having major developmental problems
2. History of domestic violence
3. Drug abuse
4. Mental illness in the family

Recruitment start date

01/07/2016

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Rock of Ages Lutheran Kindergarten
852
Hong Kong

Trial participating centre

Tsuen Wan Our Lady Kindergarten
852
Hong Kong

Trial participating centre

Tsing Yi Trade Association Kindergarten
852
Hong Kong

Trial participating centre

Kowloon Rhenish School and Kindergarten
852
Hong Kong

Trial participating centre

Sham Shui Po Baptist Church Kindergarten
852
Hong Kong

Trial participating centre

HKCS Shek Kip Mei Nursery School
852
Hong Kong

Trial participating centre

Kin Sang Baptist Church Bradbury Pre-School
852
Hong Kong

Trial participating centre

Guideposts Kindergarten 2nd Branch (Kin Sang Estate)
852
Hong Kong

Trial participating centre

Karlam Kindergarten (Tuen Mun Branch)
852
Hong Kong

Trial participating centre

Hoh Fuk Tong Kindergarten (Tuen Mun Church, CCC, HK Council)
852
Hong Kong

Trial participating centre

CCC Tuen Mun Church Kindergarten
852
Hong Kong

Trial participating centre

Lok Sin Tong Tang Tak Lim Kindergarten
852
Hong Kong

Trial participating centre

Yan Chai Hospital Ming Tak Kindergarten
852
Hong Kong

Trial participating centre

POH Mrs Chu Kwok King Memorial Kindergarten
852
Hong Kong

Trial participating centre

Yuen Long Church (CCC) Long Ping Estate Chan Kwong Kindergarten
852
Hong Kong

Trial participating centre

NAAC Yuen Long Day Nursery
852
Hong Kong

Trial participating centre

HKCS Tin Heng Nursery School
852
Hong Kong

Trial participating centre

Yuen Long Merchants Association Kindergarten
852
Hong Kong

Trial participating centre

Tai Po Rhenish Church Kindergarten 
852
Hong Kong

Trial participating centre

Tai Po Baptist Kindergarten Wan Tau Tong Estate Branch
852
Hong Kong

Trial participating centre

NAAC Fanling Day Nursery
852
Hong Kong

Trial participating centre

Dawning Views Elementi English Kindergarten
852
Hong Kong

Trial participating centre

CCWF King Shing Kindergarten
852
Hong Kong

Sponsor information

Organisation

Quality Education Fund

Sponsor details

Room 3602
36/F
Hopewell Centre
183 Queen's Road East
Wanchai
Hong Kong
852
China
2921 8833
qefenq@edb.gov.hk

Sponsor type

Government

Website

http://qef.org.hk

Funders

Funder type

Charity

Funder name

Quality Education Fund (Hong Kong)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A 2-day mass training come knowledge exchange seminar will be held to disseminate project evaluation data and experience sharing for parent educators and the public.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/07/2016: Participant information sheet uploaded.