Condition category
Mental and Behavioural Disorders
Date applied
05/11/2015
Date assigned
23/11/2015
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Being a parent is full of challenges and dealing with a child with behaviour problems can be stressful. It is well recognized, however, that there is an association between positive parenting strategies and positive child outcomes. Many studies indicate that group parent training programs for parents of children with developmental delay can lead to reduction of child behavior problems and parental stress, as well as improvement in child development.
The Poly Kids program is a parent training program for parents of preschool children with developmental delay. It consists of 16 weekly sessions for parents of children with developmental delay, equipping them with the skills and knowledge in improving their relationship with their child and managing their behavior, as well as develop strategies to promote their child’s learning, language, fine and gross motor (movement) skills.

Who can participate?
Parents of children aged between 2 years, 9 months to 4 years, 6 months identified as not developing at what would be considered a normal pace.

What does the study involve?
Participants are randomly assigned to two groups, one of which is then immediately offered the Poly Kids program (intervention group). The other group (waitlist control group) is offered the Poly Kids program once the intervention group have completed the program. The Poly Kids program is made up of 16 weekly sessions for parents. Each session lasts for two hours and includes a lecture on a particular topic, role play and homework. The participants’ children are tested on their learning, language, fine and gross motor skills by educational psychologists, speech therapists, occupational therapists and physiotherapists before the program begins and after it ends. Participants are also asked to complete questionnaires on their children’s behavior and their parenting stress before and after the program.

What are the possible benefits and risks of participating?
Participation in the study will enable parents to gain knowledge and strategies to improve the relationship with their child, manage their child’s behavior and promote their child’s learning, language, fine and gross motor skills. The results of the study can also provide important information on effective services for families with children with development delay. There is no known physical, psychological or social risk associated with participation in the program. The program content and the assessment used have been used previously with children and family. All assessment information will be kept confidential and only group results will be reported.

Where is the study run from?
The Hong Kong Polytechnic University (Hong Kong)

When is the study starting and how long is it expected to run for?
March 2015 to June 2017

Who is funding the study?
Food and Health Bureau (Hong Kong)

Who is the main contact?
Professor Cynthia Leung

Trial website

Contact information

Type

Scientific

Primary contact

Prof Cynthia Leung

ORCID ID

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

Contact details

The Hong Kong Polytechnic University
Hong Kong
0000
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Poly Kids – a multi-disciplinary parent training program to support parents of preschool children with developmental delay

Acronym

Study hypothesis

At post-intervention, the intervention group will report improvement in child learning, language skills, fine and gross motor skills, and decrease in child behavior problems and parenting stress

Ethics approval

The Hong Kong Polytechnic University Human Subjects Ethics Application Review System, 03/11/2015, ref: HSEARS20141107001-02

Study design

Single-centre intervention study using randomized controlled trial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Developmental delay

Intervention

The intervention program (Poly Kids program) consists of 16 weekly parent training sessions on understanding and accepting child condition, parent-child relationship, child management such as increasing appropriate behavior and management of inappropriate behavior, developmental milestones in language, communication, fine and gross motor functions, strategies to promote child learning, preschool concepts and language skills.

Under the supervision of the investigators, the program will be designed and delivered by a project team of professionals including educational psychologists (EP), speech therapists (ST), physiotherapists (PT) and occupational therapists (OT). Each session lasts for two hours and consists of revision of previous session’s content and homework, mini lecture on the topic to be covered, explanation and demonstration of homework of the week and role play on the homework of the week. Parents are supplied with homework activities to work with their children at home during the week. In two of the sessions, the children will attend together with the parents and the professionals will coach the parents in skills on working with their children on preschool concepts, language, fine and gross motor skills.

The control group is a waitlist control group. While the intervention group is attending the intervention program, the waitlist control group is not offered any service though they can access available services in the community provided by the government and other non-governmental organizations. The waitlist control group will be offered the Poly Kids program upon the completion of the program by the intervention group.

Both groups will be assessed on child learning, child behavior, child language skills, child fine and gross motor skills, and parenting stress before the after program completion by the intervention group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Child behavior by parent report questionnaire
2. Child learning by standardized assessment
3. Child language skills by standardized assessment
4. Child fine motor skills by standardized assessment
5. Child gross motor skills by standardized assessment

Secondary outcome measures

Parenting stress by parent report questionnaires

Overall trial start date

01/03/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of children with global developmental delay (between 1 to 2 standard deviations below the mean on developmental assessment)
2. Children should be aged between 2 years 9 months to 4.5 years at the commencement of the program
3. Children and parents should be Cantonese-speaking or can understand Cantonese
4. Parents and children should be normally living in HK
5. Parents should be living with the target children

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

260

Participant exclusion criteria

1. Parents of children with significant physical, hearing, or vision impairment
2. Parents of children with confirmed diagnosis of autism or autistic features with severe disruptive behaviour

Recruitment start date

01/05/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Hong Kong

Trial participating centre

The Hong Kong Polytechnic University
Hung Hom
Kowloon
0000
Hong Kong

Sponsor information

Organisation

Food and Health Bureau

Sponsor details

18/F
East Wing
Central Government Office
2 Tamar Avenue
Hong Kong
0000
Hong Kong

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Food and Health Bureau

Alternative name(s)

Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, FHB

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Hong Kong

Results and Publications

Publication and dissemination plan

We intend to publish the randomized controlled trial results in refereed international journals such as Research in Developmental Disabilities. We anticipate that the manuscript can be submitted for consideration for publication before the end of 2016.

Intention to publish date

01/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/09/2016: Changed recruitment end date from 30/09/2015 to 30/09/2016. Changed intend to publish date 05/09/2016: Changed overall trial end date from 31/07/2016 to 30/06/2017. Changed number of participants from 150 to 260