Contact information
Type
Scientific
Primary contact
Dr Anna Graham
ORCID ID
Contact details
University of Bristol
Division of Primary Care
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
+44 (0)117 9287205
a.graham@bris.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
S/13/Graham/98
Study information
Scientific title
Acronym
Study hypothesis
Principle research questions:
1. To determine the availability of EC in Avon for the under 16s
2. To develop an intervention in schools, delivered by teachers, to increase teenagers knowledge about EC
3. To evaluate the effectiveness of the intervention in a randomised controlled trial (RCT) in schools in Avon, using a cluster based design
Ethics approval
Not provided at time of registration
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Pregnancy; emergency contraception
Intervention
Added 12/01/10:
Teachers gave a single lesson on emergency contraception to year 10 pupils. The teachers had previously received in-service training on giving the lesson. The pupils were actively involved during the lesson.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
To improve awareness of EC amongst 14/15 year olds in Avon
Secondary outcome measures
1. To map the provision of EC for the under 16s in Avon
2. To evaluate the effectiveness of a school based, teacher led, intervention to improve knowledge of the time limits for use of EC
3. To obtain data on pupils knowledge and attitudes towards EC; where they believe EC can be obtained, what they believe the side effects to be, how effective EC is, and how they view the safety of EC
4. To obtain data within this sample, of rates of sexual activity and use of EC
Overall trial start date
01/10/1998
Overall trial end date
01/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Year 10 pupils (age 14-15 years) in 24 schools from the four Local Education Authorities that make up Avon Health Authority
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
3794 (1974 boys; 1820 girls; 24 schools) (added 12/01/10, see publication)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/10/1998
Recruitment end date
01/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
Bristol
BS8 2PR
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (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
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12016180
Publication citations
-
Results
Graham A, Moore L, Sharp D, Diamond I, Improving teenagers' knowledge of emergency contraception: cluster randomised controlled trial of a teacher led intervention., BMJ, 2002, 324, 7347, 1179.