Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000569808
Ethics application status
Approved
Date submitted
28/05/2012
Date registered
28/05/2012
Date last updated
28/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Cluster Randomised Evaluation of a Printed Contraception Educational Material for Young People
Scientific title
Cluster randomised evaluation of a general audience versus a youth-focused printed education information resource to improve contraception knowledge and attitudes in adolescents and young people
Secondary ID [1] 279926 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 285840 0
Condition category
Condition code
Reproductive Health and Childbirth 286020 286020 0 0
Contraception
Public Health 286834 286834 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family Planning NSW has developed and will evaluate a new print resource (booklet), the purpose of which is to supply relevant and accurate information about contraception for young people. The evaluation aims to compare the effectiveness of the new youth-friendly contraception booklet to our current booklet. Investigators will utilise a cluster randomised design to compare contraceptive knowledge and attitudes before and after reading one of the two booklets. Investigators will recruit 24 Youth Centres to participate in the research and each location will be randomised to one of two groups: 1) current contraceptive booklet, or 2) new youth-friendly booklet. Participating Youth Centre study coordinators will each recruit 15 participants between the ages of 14-24 years. After enrolment and providing informed consent, participants will complete a baseline survey assessing contraceptive knowledge and attitudes and will then be asked to read the booklet over the next one to two weeks. Two weeks after receiving the booklet, each participant will be asked to complete an online follow-up survey also assessing knowledge, attitudes and general satisfaction with the resource.
Intervention code [1] 284253 0
Prevention
Comparator / control treatment
Current general audience contraceptive booklet
Control group
Active

Outcomes
Primary outcome [1] 286508 0
Contraception knowledge increase assessed by 19 knowledge questions in a self-administered baseline paper-based questionnaire and on-line follow-up survey.
Timepoint [1] 286508 0
Baseline and 4 weeks post baseline
Secondary outcome [1] 296043 0
Contraception attitude improvement assessed by 12 attitude questions in a self-administered baseline paper-based questionnaire and on-line follow-up survey.
Timepoint [1] 296043 0
Baseline and 4 weeks post baseline

Eligibility
Key inclusion criteria
a) aged between 14-24; & b) if 14-15 years old, have previously received in-school or parental / guardian sexual health education.
Minimum age
14 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Investigators will utilise a cluster randomised design to compare contraceptive knowledge and attitudes before and after viewing one of the two booklets. Investigators will recruit 24 Youth Centres to participate in the research and each Centre will be randomised to one of two groups: 1) current contraceptive booklet, or 2) new youth-friendly booklet. Participating Youth Centre study coordinators will each recruit 15 participants between the ages of 14-24 years who will be given the pamphlet according to the randomisation assignment. Study coordinators recruiting subjects at the study locations are unaware of the allocation which has been completed centrally; the contraception booklets are placed in opaque envelopes to be opened by the subject after enrolling and completing the baseline survey.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random numbers table will be used to assign Youth Centres.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284700 0
Charities/Societies/Foundations
Name [1] 284700 0
Family Planning New South Wales
Country [1] 284700 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Family Planning New South Wales
Address
328-336 Liverpool Road
Ashfield NSW 2131
Country
Australia
Secondary sponsor category [1] 284181 0
None
Name [1] 284181 0
Address [1] 284181 0
Country [1] 284181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286702 0
Family Planning New South Wales
Ethics committee address [1] 286702 0
328-336 Liverpool Road
Ashfield NSW 2131
Ethics committee country [1] 286702 0
Australia
Date submitted for ethics approval [1] 286702 0
07/02/2012
Approval date [1] 286702 0
21/03/2012
Ethics approval number [1] 286702 0
EC00120

Summary
Brief summary
Family Planning NSW has developed and will evaluate a new print resource (booklet), the purpose of which is to supply essential, relevant and accurate information about contraception for young people. The evaluation aims to compare the effectiveness of the new youth-friendly contraception booklet to our current booklet. Investigators will utilise a cluster randomised design to compare contraceptive knowledge and attitudes before and after viewing one of the two booklets. Investigators will recruit 24 Youth Centres to participate in the research and each Centre will be randomised to one of two groups: 1) current contraceptive booklet, or 2) new youth-friendly booklet. Participating Youth Centre study coordinators will each recruit 15 participants between the ages of 14-24 years. After enrolment and providing informed consent, participants will complete a baseline survey assessing contraceptive knowledge and attitudes and will then be asked to read the booklet over the next one to two weeks. Two weeks after receiving the booklet, each participant will be asked to complete the online follow-up survey also assessing knowledge, attitudes and general satisfaction with the resource.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33768 0
Address 33768 0
Country 33768 0
Phone 33768 0
Fax 33768 0
Email 33768 0
Contact person for public queries
Name 17015 0
Anne Dore
Address 17015 0
Family Planning New South Wales
328-336 Liverpool Road
Ashfield NSW 2131
Country 17015 0
Australia
Phone 17015 0
+61 02 8752 4300
Fax 17015 0
Email 17015 0
[email protected]
Contact person for scientific queries
Name 7943 0
Anne Dore
Address 7943 0
Family Planning New South Wales
328-336 Liverpool Road
Ashfield NSW 2131
Country 7943 0
Australia
Phone 7943 0
+61 02 8752 4300
Fax 7943 0
Email 7943 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.