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
The effects of parenting intervention on quality of life and parental confidence in management of young asthmatic children
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
Not available in web format, please use the contact details to request a 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
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