NCT07800689

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 7, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 23, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Carer aromatherapy trainingGlobal developmental delayCOM-B

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (1)

  • Psychosocial well-being on parents

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

Study Arms (1)

Parents with children having global developmental delay.

EXPERIMENTAL

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

Interventions

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).

Parents with children having global developmental delay.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Carers cannot communicate with English or Chinese.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

    PMID: 12787154BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Interventions

MassageOils, Volatile

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationOilsLipids

Central Study Contacts

Sze Ki Veronica LAI, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The IFPA aromatherapy who delivers the training programme will be masked for the outcome measurements.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2026

First Posted

September 2, 2026

Study Start

June 7, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ICF
Time Frame
From the start day to the end of the project.
Access Criteria
The PI and the research assistant.

Locations