Condition category
Not Applicable
Date applied
07/03/2011
Date assigned
07/03/2011
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.