Measures to Address Maternal Anxiety
| ISRCTN | ISRCTN12504076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12504076 |
| Protocol serial number | 9932 |
| Sponsor | Imperial College London (UK) |
| Funder | Lincoln Medical (UK) |
- Submission date
- 07/03/2011
- Registration date
- 07/03/2011
- Last edited
- 24/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thisanayagam Umasunthar
Scientific
Scientific
Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom
| t.umasunthar@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional process of care |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Measures to Address Maternal Anxiety: a randomised control study |
| Study acronym | MAMA |
| Study objectives | 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(s) | West London Research Ethics Committee 2, ref: REC10/H0711/76 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
State anxiety (STAI) score; Timepoint(s): 6 weeks (primary outcome) and 12 months (secondary outcome) |
| Key secondary outcome measure(s) |
Successful administration of adrenaline using a trainer device, judged by an independent observer; Timepoint(s): 6 weeks (primary) and 12 months (secondary) |
| Completion date | 02/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/02/2011 |
| Date of final enrolment | 02/03/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wright-Fleming Institute
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/02/2016: Publication reference added.
