Condition category
Not Applicable
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
03/08/2009
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 Daniel Wight

ORCID ID

Contact details

MRC Social and Public Health Sciences Unit
4 Lilybank Gardens
Glasgow
G12 8RZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

E354/77

Study information

Scientific title

Acronym

Study hypothesis

To evaluate whether a specially designed teacher-delivered sex education programme for young people aged 13-15 has any effect on sexual risk taking and the incidence of unwanted sexual outcomes

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Public health, social medicine

Intervention

Teacher-delivered sex education programme/control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cumulative termination rate by age 20 and reported incidence of first intercourse without a condom.

Secondary outcome measures

Cognitions associated with safer sex, reported coercive sexual encounters, regretted sexual experience, use of sexual health services, etc.

Overall trial start date

01/01/1996

Overall trial end date

25/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Non-denominational secondary state schools in Tayside and Lothian Regions and pupils attending these schools.

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

24 schools, 7200 pupils (3400 in each arm)

Participant exclusion criteria

Roman Catholic schools and pupils who opt out of the research.

Recruitment start date

01/01/1996

Recruitment end date

25/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Social and Public Health Sciences Unit
Glasgow
G12 8RZ
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17118950

Publication citations

  1. Results

    Henderson M, Wight D, Raab GM, Abraham C, Parkes A, Scott S, Hart G, Impact of a theoretically based sex education programme (SHARE) delivered by teachers on NHS registered conceptions and terminations: final results of cluster randomised trial., BMJ, 2007, 334, 7585, 133, doi: 10.1136/bmj.39014.503692.55.

Additional files

Editorial Notes