Contact information
Type
Scientific
Primary contact
Dr Thisanayagam Umasunthar
ORCID ID
Contact details
Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom
-
t.umasunthar@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9932
Study information
Scientific title
Measures to Address Maternal Anxiety: a randomised control study
Acronym
MAMA
Study hypothesis
This is a factorial randomised controlled trial of two different interventions in the same population, to answer two different questions. The first intervention compares two adrenaline auto-injector devices, namely Anapen® and EpiPen®, to evaluate whether one is easier than the other for parents of a food allergic child to learn to use effectively. The second intervention compares two different methods for discussing risks associated with food allergy with mothers of food allergic children, to evaluate their effect on maternal anxiety. 200 mothers with children who have food allergy will be randomised to one of four groups in a 2x2 factorial study design. The primary outcome measure for the comparison of adrenaline auto-injectors is effective delivery of adrenaline in a simulated scenario 6 weeks after training, using a trainer auto-injector device. The primary outcome measure for the informational intervention is maternal state anxiety score 6 weeks after the intervention.
Ethics approval
West London Research Ethics Committee 2, ref: REC10/H0711/76
Study design
Randomised interventional process of care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the conatct details below to request a patient information sheet
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
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 approach to discussing food allergy or current standard of care.
Study Entry: Single Randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
State anxiety (STAI) score; Timepoint(s): 6 weeks (primary outcome) and 12 months (secondary outcome)
Secondary outcome measures
Successful administration of adrenaline using a trainer device, judged by an independent observer; Timepoint(s): 6 weeks (primary) and 12 months (secondary)
Overall trial start date
28/02/2011
Overall trial end date
02/03/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant 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
Recruitment start date
28/02/2011
Recruitment end date
02/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wright-Fleming Institute
London
W2 1PG
United Kingdom
Funders
Funder type
Industry
Funder name
Lincoln Medical (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25850463