Condition category
Respiratory
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
28/08/2014
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 Lynne Webster

ORCID ID

Contact details

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
lynne.webster@cmft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8624

Study information

Scientific title

Acronym

Study hypothesis

The study will be a randomised controlled trial comparing care as usual versus care as usual supplemented by group-delivered Triple P parenting seminars and telephone support in parents/carers of 2 - 7 year old asthmatic children.

Ethics approval

MREC approved, ref: 09/H1017/115

Study design

Single-centre randomised interventional treatment pilot/feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Intervention

Triple P parenting seminars and telephone support.

Follow-up length: 9 months
Study entry: registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), measured at 3 and 9 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2010

Overall trial end date

09/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of children with frequent episodic or chronic persistent asthma who are taking regular preventive medication
2. Parents must have an asthmatic child aged 2 - 7 years, either sex
3. Diagnosis of asthma in children, based on:
3.1. An observation of recurrent episodes of wheeze (preferably witnessed by a medical observer)
3.2. A clinical response to a bronchodilator medication (eg. Salbutamol)
3.3. An absence of other rarer lung conditions (e.g., cystic fibrosis, chronic neonatal lung disease) which may account for these symptoms

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 180

Participant exclusion criteria

1. The child has a significant disability
2. The parents are currently seeing a professional for the child's behaviour difficulties, are currently receiving psychological help or counselling, or have significant learning difficulties. For the purposes of the study, in order to participate in the seminars, parents will be excluded if they don't understand English.

Recruitment start date

01/06/2010

Recruitment end date

09/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK)

Sponsor details

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cmft.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) Research for Patient Benefit (RfPB) programme

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

Publication citations

Additional files

Editorial Notes