An interventional study of 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 Global Developmental Delay, sponsored by Hong Kong Metropolitan University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Hong Kong Metropolitan University · Not applicable, Interventional, and Supportive care
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.
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.
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.
270 studies on the registry are indexed under Learning Disabilities; 62 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 181 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →Hong Kong Metropolitan University is the lead sponsor of 56 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
The 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
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
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).
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.
Time frame: From enrollment to the end of the qualitative interview
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.
Time frame: From enrollment to the end of the qualitative interview up to 40 weeks
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.
Time frame: From enrollment to the end of the intervention up to 40 weeks
Plan to share: Yes — Only data related to the primary and secondary outcomes will be shared.
Supporting information: Informed consent form
Time frame: From the start day to the end of the project.
Access criteria: The PI and the research assistant.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 96 non-industry interventional studies with no phase under Learning Disabilities, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 53. This study's planned 6 months is below that.
Counting every sponsor, half of 99 studies reached it within 29 months; a quarter within 9 and three quarters within 51.
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Hong Kong Metropolitan University