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Global Developmental DelayCAT programmeNCT07800689

Design and Implementation of a Carer Aromatherapy Training (CAT) Program for Children With Global Developmental Delay in Hong Kong: A Mixed Qualitative Study Using the COM-B Framework

A study testing Carer Aromatherapy Training (CAT) program and home massage with massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut oil in people with Global Developmental Delay, run by Hong Kong Metropolitan University at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This project aims to design and implement a Carer Aromatherapy Training (CAT) program, guided by the Capability, Opportunity, Motivation and Behaviour (COM-B) model, to empower carers with safe and effective aromatherapy practices. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Global Developmental Delay
What is being tested?
Carer Aromatherapy Training (CAT) program and home massage with massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteHong Kong
Study dates
7 Jun 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Carer aged 18 or above (preferably parents) with children having global developmental delay.
  • Carers who has not received any aromatherapy training.

Who cannot join

  • Carers cannot communicate with English or Chinese.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sze Ki Veronica LAI, Dr contact

85239708737

sklai@hkmu.edu.hk

Hong Kong1 site, 1 recruiting
  • Hong Kong Metropolitan University

    Hong Kong

    Sze Ki Veronica LAI, Dr, 85239708737, sklai@hkmu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

This project aims to design and implement a Carer Aromatherapy Training (CAT) program, guided by the Capability, Opportunity, Motivation and Behaviour (COM-B) model, to empower carers with safe and effective aromatherapy practices.

Methods This study will employ a mixed-methods approach to explore behavioural changes and the experience of adopting the CAT programme among parents of children with physical disabilities in Hong Kong. Around 30 carers (preferably parents) of children with global developmental delay from different districts of Hong Kong will be recruited to participate in CAT Program. Following participants' consent to participate, a a one-day (8-hour) face-to-face training program will be given to carers being recruited in the study.

Read more

One session of introduction will be given to staffs by certified IFPA aromatherapy nurse in centres on the first session of training programme for introducing the theories of aromatherapy, the possible benefit behind and safety issues they must be aware of. Afterwards, massage sessions will be demonstrated with standardised effleurage, on abdomen and four limbs and return demonstrated.

After the training program, each carer is required to provide a 4-week aromatherapy massage to his/her child (twice per week for around 10-15 minutes).

Qualitative data will be collected from semi-structured interviews and focus groups with questions set based on COM-B framework. Quantitative data will be collected through pre- and post-training surveys and analysed using descriptive statistics and t-test to measure changes in carers motivation and behaviour before and after the CAT programme intervention.

Expected Outcomes and implications Integration of findings will provide a comprehensive understanding of the training's impact. The study is expected to demonstrate that behaviourally-informed training can improve care delivery, to strengthen workforce resilience and improve care quality.

Read the detailed description

Purpose Global developmental delay (GDD) involves significant delays in two or more developmental domains and affects approximately 1-3% of children under the age of 5 years worldwide.The causes of Global Developmental Delay (GDD) are often unknown; however, when identified, they are most commonly associated with genetic factors such as chromosomal abnormalities, single-gene disorders, or copy number variations.

Study Designs The Capacity, Opportunity and Motivation Behaviour (COM-B) model will be used to design and implement a Carer Aromatherapy Training (CAT) program. COM-B model is a theoretical framework for understanding and supporting behaviour change, consisting of six components that are hypothesised to drive behaviour change, namely capacity (physical capability and psychological capability), opportunity (physical opportunity and social opportunity) and motivation (reflective motivation and automatic motivation). This design allows for a comprehensive understanding of behavioural changes among carers by first identifying measurable outcomes and then exploring the underlying experiences and contextual factors.

The study employed a mixed-methods approach to have a better understanding both the quantitative outcomes of behaviour change and the qualitative experiences of carers of children diagnosed with global developmental delay in Hong Kong during and after training.

Carer Aromatherapy Training (CAT) program This program aims to provide aromatherapy training to carers of children diagnosed with GDD in Hong Kong to: i) provide standard training in aromatherapy for carers of children diagnosed with GDD; ii) improve the interaction between carers and children diagnosed with GDD; and iii) explore the changes in carers' capability, opportunity and motivation to use aromatherapy in daily care routines.

Following participants' consent to participate, a a one-day (8-hour) face-to-face training program will be given to carers being recruited in the study. The program will be held in activity rooms of Special Child Care Centres (SCCC) or classrooms. It consists of three modules: (1) Introduction of aromatherapy massage with safety concerns, (2) demonstration of massag steps and (3) return demonstration.

One session of introduction will be given to staffs by certified IFPA aromatherapy nurse in centres on the first session of training programme for introducing the theories of aromatherapy, the possible benefit behind and safety issues they must be aware of. Afterwards, massage sessions will be demonstrated with standardised effleurage, which mould our hands to the shape of the body being massaged on abdomen and four limbs and return demonstrated. Massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut carrier oil will be used.

After the training program, each carer is required to provide a 4-week aromatherapy massage to his/her child (twice per week for around 10-15 minutes).

Incentive to participants To increase the compliance and incentive of participants to complete the whole training program, HK$150 supermarket coupon will be given to each carer who finished the whole program and focus group interview for investigating the adaptation of CAT programme and a job satisfaction questionnaire.

After the training program, each carer is required to provide a 4-week aromatherapy massage to his/her child (twice per week for around 10-15 minutes).

Qualitative data from semi-structured interviews and focus groups with questions set based on COM-B framework will be audio-recorded, transcribed verbatim and organized using field notes with the help of Nvivo 12. Quantitative data will be collected as the parental stress level using the Chinese version of the Parenting Stress Index (PSI-SF) (4th version) through pre- and post-training surveys and analysed using descriptive statistics and t-test to measure changes in carers motivation and behaviour before and after the CAT programme intervention.

Expected Outcomes and implications Integration of findings will provide a comprehensive understanding of the training's impact. If the programme is effective, carers will gain improved capability through targeted training, leading to greater confidence in delivering person-centred care. Besides, by addressing motivational factors and creating supportive opportunities, carers can reduce parental stress and burnout as well as improving wellbeing of both carers and children with physical disability.

For the population, children with physical disability will benefit from more consistent, empathetic, and responsive care, which can enhance their overall health, wellbeing, and dignity.

Being tested
Carer Aromatherapy Training (CAT) program and home massage with massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut oil
Keywords
Carer aromatherapy training, Global developmental delay, COM-B
Medical subject headings
Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carer Aromatherapy Training (CAT) program and home massage with massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut oilOther

    Carer Aromatherapy Training (CAT) program Following participants' consent to participate, an 8-hour face-to-face training program will be given to carers being recruited in the study. The program consists of three modules: (1) Introduction of aromatherapy massage with safety concerns, (2) demonstration of massag steps and (3) return demonstration.

    One session of introduction will be given to staffs by certified IFPA aromatherapy nurse in centres on the first session of training programme for introducing the theories of aromatherapy, the possible benefit behind and safety issues they must be aware of. Afterwards, massage sessions will be demonstrated with standardised effleurage, which mould our hands to the shape of the body being massaged on abdomen and four limbs and return demonstrated.

    After the training program, each carer is required to provide a 4-week aromatherapy massage to his/her child (twice per week for around 10-15 minutes).

Study groups in NCT07800689
Study groupRoleWhat they receive
Parents with children having global developmental delay.ExperimentalThe inclusion criteria of participants are: 1. Carer aged 18 or above (preferably parents) with children having global developmental delay. 2. Carers who has not received any aromatherapy training. Following participants' consent to participate, an 8-hour face-to-face training program will be given to carers being recruited in the study. The program will be held in an activity room of special child care centres. It consists of three modules: (1) Introduction of aromatherapy massage with safety, (2) demonstration of massage steps and (3) return demonstration
Receives: Other: Carer Aromatherapy Training (CAT) program and home massage with massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut oil

What is being measured

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

  1. To explore the behaviour change and the experience of adopting CAT programme among parents with children suffer physical disability in Hong Kong.

    Measurements The Capacity, Opportunity and Motivation Behaviour (COM-B) model is a theoretical framework for understanding and supporting behaviour change, consisting of six components that are hypothesised to drive behaviour change, namely capacity (physical capability and psychological capability), opportunity (physical opportunity and social opportunity) and motivation (reflective motivation and automatic motivation). This design allows for a comprehensive understanding of behavioural changes among carers by first identifying measurable outcomes and then exploring the underlying experiences and contextual factors.

    Measured: From enrollment to the end of the qualitative interview

  2. Explore the behaviour change and the experience of adopting CAT programme among parents with children suffer physical disability in Hong Kong.

    MeasurementsThe Capacity, Opportunity and Motivation Behaviour (COM-B) model is a theoretical framework for understanding and supporting behaviour change, consisting of six components that are hypothesised to drive behaviour change, namely capacity (physical capability and psychological capability), opportunity (physical opportunity and social opportunity) and motivation (reflective motivation and automatic motivation). This design allows for a comprehensive understanding of behavioural changes among carers by first identifying measurable outcomes and then exploring the underlying experiences and contextual factors.

    Measured: From enrollment to the end of the qualitative interview up to 40 weeks

Secondary outcomes (1)
  1. Psychosocial well-being on parents

    The secondary outcome is parental stress, assessed using the Chinese version of the Parenting Stress Index (PSI-SF, 4th version) before and after the intervention.Parenting stress level was assessed using the Chinese version of the Parenting Stress Index (PSI-SF) (4th version), which has been validated as an appropriate tool for measuring parenting stress among Chinese mothers in Hong Kong, with a reliability coefficient of 0.93. The PSI-SF (4th version) consists of 3 subscales and 36 items in total, with 12 items in each of the 3 subscales): difficult child (DC), parental distress (PD), and parent-child dysfunctional interaction (P-CDI). A 5-point Likert-type scale is used, ranging from 1 (strongly agree) to 5 (strongly disagree) with a total score ranging from 36-180. The overall reliability of the Chinese version of the PSI-SF was 0.89. A total raw score of ≥ 90 (i.e., at or above the 90th percentile) indicates significant stress in the parent-child dyad.

    Measured: From enrollment to the end of the intervention up to 40 weeks

Timeline

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

  1. First posted2 Sep 2026
  2. Study start7 Jun 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800689
Sponsor's protocol ID
HE-RGC2026/NHS10
Other IDs
FRSF/2025/09
Acronym
CAT programme
Status last verified
Aug 2026
First submitted
23 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only data related to the primary and secondary outcomes will be shared.

Publications

  • Baker BL, McIntyre LL, Blacher J, Crnic K, Edelbrock C, Low C. Pre-school children with and without developmental delay: behaviour problems and parenting stress over time. J Intellect Disabil Res. 2003 May-Jun;47(Pt 4-5):217-30. doi: 10.1046/j.1365-2788.2003.00484.x.

    PubMed 12787154

Questions about this trial

What is this clinical trial studying?

A study testing Carer Aromatherapy Training (CAT) program and home massage with massage oil with the mixture of Petitgrain Mandarin (Citrus reticulate) essential oil and fractionated coconut oil in people with Global Developmental Delay, run by Hong Kong Metropolitan University 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 1 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sze Ki Veronica LAI, Dr (85239708737, sklai@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To explore the behaviour change and the experience of adopting CAT programme among parents with children suffer physical disability in Hong Kong. (time frame: From enrollment to the end of the qualitative interview). The study lists 2 primary outcomes in all. 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 NCT07800689, 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 2 Sep 2026.

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