Improving teenagers understanding of emergency contraception (EC)

ISRCTN	ISRCTN16641272
DOI	https://doi.org/10.1186/ISRCTN16641272
Protocol serial number	S/13/Graham/98
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Anna Graham
Scientific

University of Bristol
Division of Primary Care
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Phone	+44 (0)117 9287205
Email	a.graham@bris.ac.uk

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	To improve awareness of EC amongst 14/15 year olds in Avon
Key secondary outcome measure(s)	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
Completion date	01/10/2001

Participant type(s)	Patient
Age group	Child
Lower age limit	14 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	3794
Key inclusion criteria	Year 10 pupils (age 14-15 years) in 24 schools from the four Local Education Authorities that make up Avon Health Authority
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/1998
Date of final enrolment	01/10/2001

University of Bristol

Bristol
BS8 2PR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/05/2002		Yes	No