Topic: Medicines for Children Research Network
Conditions
Interventions
Adrenaline auto-injector: participants will be randomised to receive training with either Anapen® or EpiPen®.
Informational intervention: participants will be randomised to receive either a new approa
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| State anxiety (STAI) score; Timepoint(s): 6 weeks (primary outcome) and 12 months (secondary outcome) | — |
Secondary
| Measure | Time frame |
|---|---|
| Successful administration of adrenaline using a trainer device, judged by an independent observer; Timepoint(s): 6 weeks (primary) and 12 months (secondary) | — |
Countries
United Kingdom
Outcome results
None listed