[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654538":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":22,"armGroups":31,"interventions":38,"overallOfficials":22,"centralContacts":43,"locations":49,"responsibleParty":62,"collaborators":22,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":22,"enrollmentInfo":76,"targetDuration":22,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":51,"whyStopped":22,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Hong Kong Metropolitan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":16},"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",[18],{"measure":19,"description":20,"timeFrame":21},"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.","From enrollment to the end of the intervention up to 40 weeks",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":28,"maskingDescription":29,"whoMasked":22},"NONE","The IFPA aromatherapy who delivers the training programme will be masked for the outcome measurements.","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.\n\nStudy 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.\n\nThe 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.\n\nCarer 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.\n\nFollowing 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.\n\nOne 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.\n\nAfter the training program, each carer is required to provide a 4-week aromatherapy massage to his\u002Fher child (twice per week for around 10-15 minutes).\n\nIncentive 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.\n\nAfter the training program, each carer is required to provide a 4-week aromatherapy massage to his\u002Fher child (twice per week for around 10-15 minutes).\n\nQualitative 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.\n\nExpected 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.\n\nFor the population, children with physical disability will benefit from more consistent, empathetic, and responsive care, which can enhance their overall health, wellbeing, and dignity.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"Parents with children having global developmental delay.","EXPERIMENTAL","The inclusion criteria of participants are:\n\n1. Carer aged 18 or above (preferably parents) with children having global developmental delay.\n2. 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",[37],"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",[39],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":22},"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.\n\nOne 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.\n\nAfter the training program, each carer is required to provide a 4-week aromatherapy massage to his\u002Fher child (twice per week for around 10-15 minutes).",[33],[44],{"name":45,"role":46,"phone":47,"phoneExt":22,"email":48},"Sze Ki Veronica LAI, Dr","CONTACT","85239708737","sklai@hkmu.edu.hk",[50],{"facility":5,"status":51,"city":52,"state":22,"zip":22,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Hong Kong","HK",{"type":55,"coordinates":56},"Point",[57,58],114.17469,22.27832,{"lat":58,"lon":57},[61],{"name":45,"role":46,"phone":47,"phoneExt":22,"email":48},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Dr Veronica LAI Sze Ki","Assistant Professor","100654538","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-100654538",false,"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","Inclusion Criteria:\n\n* Carer aged 18 or above (preferably parents) with children having global developmental delay.\n* Carers who has not received any aromatherapy training.\n\nExclusion Criteria:\n\n* Carers cannot communicate with English or Chinese.",true,"ALL","18 Years",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[24],"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.\n\nMethods 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.\n\nOne 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.\n\nAfter the training program, each carer is required to provide a 4-week aromatherapy massage to his\u002Fher child (twice per week for around 10-15 minutes).\n\nQualitative 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.\n\nExpected 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.",[83],"Global Developmental Delay",[85,86,87],"Carer aromatherapy training","Global developmental delay","COM-B","2026-08-31",{"date":90,"type":91},"2026-09-02","ACTUAL",{"date":93,"type":91},"2026-06-07",{"date":95,"type":78},"2027-06-30",{"name":5,"class":6},1]