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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 (CAT programme)

31 sierpnia 2026 zaktualizowane przez: Dr Veronica LAI Sze Ki, Hong Kong Metropolitan University

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Sze Ki Veronica LAI, Dr
  • Numer telefonu: 85239708737
  • E-mail: sklai@hkmu.edu.hk

Lokalizacje studiów

      • Hong Kong, Hongkong
        • Rekrutacyjny
        • Hong Kong Metropolitan University
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

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

Exclusion Criteria:

  • Carers cannot communicate with English or Chinese.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Parents with children having global developmental delay.

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

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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
To explore the behaviour change and the experience of adopting CAT programme among parents with children suffer physical disability in Hong Kong.
Ramy czasowe: From enrollment to the end of the qualitative interview
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.
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.
Ramy czasowe: From enrollment to the end of the qualitative interview up to 40 weeks
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.
From enrollment to the end of the qualitative interview up to 40 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Psychosocial well-being on parents
Ramy czasowe: From enrollment to the end of the intervention up to 40 weeks
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.
From enrollment to the end of the intervention up to 40 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 grudnia 2026

Ukończenie studiów (Szacowany)

30 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

23 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

2 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • HE-RGC2026/NHS10
  • FRSF/2025/09 (Inny numer grantu/finansowania: Hong Kong Metropolitan University)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Only data related to the primary and secondary outcomes will be shared.

Ramy czasowe udostępniania IPD

From the start day to the end of the project.

Kryteria dostępu do udostępniania IPD

The PI and the research assistant.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .