- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07800689
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)
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Sze Ki Veronica LAI, Dr
- Telefoonnummer: 85239708737
- E-mail: sklai@hkmu.edu.hk
Studie Locaties
-
-
-
Hong Kong, Hongkong
- Werving
- Hong Kong Metropolitan University
-
Contact:
- Sze Ki Veronica LAI, Dr
- Telefoonnummer: 85239708737
- E-mail: sklai@hkmu.edu.hk
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Parents with children having global developmental delay.
The inclusion criteria of participants are:
|
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). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To explore the behaviour change and the experience of adopting CAT programme among parents with children suffer physical disability in Hong Kong.
Tijdsspanne: 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.
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Psychosocial well-being on parents
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Neurologische gedragsmanifestaties
- Neurologische ontwikkelingsstoornissen
- Communicatiestoornissen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Leerproblemen
- Therapeutica
- Lipiden
- Complementaire therapieën
- Modaliteiten fysiotherapie
- Revalidatie
- Oliën
- Therapie, zacht weefsel
- Musculoskeletale manipulaties
- Massage
- Oliën, vluchtig
Andere studie-ID-nummers
- HE-RGC2026/NHS10
- FRSF/2025/09 (Ander subsidie-/financieringsnummer: Hong Kong Metropolitan University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .