Measures to Address Maternal Anxiety
- Conditions
- Topic: Medicines for Children Research NetworkSubtopic: All DiagnosesDisease: All DiseasesNot ApplicableChildren with food allergy
- Registration Number
- ISRCTN12504076
- Lead Sponsor
- Imperial College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Pilot phase:
Parents of children attending the paediatric outpatient department at St Mary's Hospital ? food allergic/atopic/healthy groups categorised according to diagnoses made by the treating clinician. Food allergic group will be limited to those with IgE-mediated food allergy.
Main study:
1. Children aged 0-18 with food allergy (and their mother) diagnosed at a tertiary paediatric allergy clinic and need for adrenaline auto-injector prescription due to risk of anaphylaxis
2. Patient weight = 7.5 kg
3. Ability to converse fluently and read instructions in English or with an appropriate translator
Pilot phase:
Parents of children with known non-atopic chronic diseases likely to impact on maternal anxiety and stress will be excluded from this pilot phase
Main study:
1. Previous training to use an injectable adrenaline device
2. Known psychiatric morbidity such as psychotic disorders which might be expected to impact on the validity and appropriateness of the psychological intervention
3. Poor English language fluency and/or poor reading ability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method State anxiety (STAI) score; Timepoint(s): 6 weeks (primary outcome) and 12 months (secondary outcome)
- Secondary Outcome Measures
Name Time Method Successful administration of adrenaline using a trainer device, judged by an independent observer; Timepoint(s): 6 weeks (primary) and 12 months (secondary)