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Pilot study to develop and assess the feasibility and acceptability of Positive Choices: a school-based social marketing intervention to improve sexual health and reduce unintended teenage pregnancies in England

Optimisation, feasibility testing and pilot randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12524938
Enrollment
1080
Registered
2017-07-03
Start date
2017-11-01
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unintended teenage pregnancy and sexual health Pregnancy and Childbirth Unintended teenage pregnancy and sexual health

Interventions

This study consists of three parts. Part 1: This phase of the study consists of the facilitated, systematic optimisation of the Positive Choices intervention. ‘Positive Choices’ is a manualised soci
managing emotions
understanding and building trusting relationships
exploring others’ needs and avoiding conflict
and, maintaining and repairing relationships. Sexual health modules cover: healthy relationships
negotiation and communication skills
positive sexual health
sexual risk reduction
contraception
and local services. Informed by the needs-assessment data, School Health Promotion Councils select: in what order to deliver modules
whether to deliver within personal, social and health education (PSHE), tutor groups or integrated into other lessons (e.g. English)
and whether to use our materials or existing materials if these confor

Sponsors

London School of Hygiene & Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Secondary school student nearing the end of year 8

Exclusion criteria

Exclusion criteria: No students in participating schools will be excluded from our study. Those with mild learning difficulties or poor English will be supported to complete the questionnaire by fieldworkers. Private schools, pupil referral units or schools for those with learning disabilities are excluded. Boys’ (but not girls’) schools will be excluded from the pilot and full trial since our primary outcome focuses on unintended pregnancies among girls.

Design outcomes

Primary

MeasureTime frame
Feasibility testing phase: Meeting the criteria for progression to a pilot RCT (70% fidelity and 70% acceptability in one school) measured at 12 months by a tick box fidelity assessment, observations in the school where the intervention is implemented and interviews and focus groups with students and staff. Pilot meeting the progression criteria to a phase III trial comprising: 1. The intervention is implemented with fidelity in =3 of 4 intervention schools 2. Process evaluation indicates that the intervention is acceptable to a majority of students and staff involved in implementation 3. Randomisation occurs and =5 of 6 schools accept randomization and continue within the study 4. Student questionnaire follow up rates are =80% in =5 of 6 schools 5. Linkage of self-report and routine administrative data on pregnancies and terminations is feasible. These are measured at 12 months by a tick box fidelity assessment, observations in schools where the intervention is implemented, interviews and focus groups with students and staff, statistical assessment of survey follow up rates; and successful testing of data linkage. In a phase III trial: Unintended teenage pregnancy measured by linking routine data on births and terminations at 48 months (age 16/17) and secondary outcomes via self-reports at 24months (age 14/15) to study participants.

Secondary

MeasureTime frame
1. Pregnancy (initiation of pregnancy) and unintended pregnancy is measured using self-report questionnaire measures adapted from the RIPPLE Trial at 12 months 2. Sexually transmitted infections is measured using self-report questionnaire measures adapted from Natsal3 at 12 months 3. Age of sexual debut, number of sexual partners, use of contraception at first and last sex is measured using self-report questionnaire measures adapted from the SHARE Trial and Natsal3 at 12 months 4. Non-volitional sex is measured using self-report questionnaire measures adapted from the Conflict in Adolescent Dating Relationships Inventory at 12 months 5. Educational attainment is measured using school routine administrative data at 12 months. 6. School-level social norms supportive of positive relationships and sexual health are measured using self-report questionnaire measures adapted from the Safer Choices trial at 12 months 7. Individual-level sexual health knowledge and skills and contraceptive skills and access is measured using self-report questionnaire measures adapted from the SHARE Trial at 12 months 8. Self-efficacy is measured using self-report questionnaire measures adapted from the SHARE Trial and the Sexual Communication Self-Efficacy Scale at 12 months 9. Sexual competence is measured using self-report questionnaire measures adapted from Natsal3 at 12 months 10. Communication with parents is measured using self-report questionnaire measures adapted from the RIPPLE Trial at 12 months 11. School engagement is measured using the Beyond Blue School Climate Self-Report Questionnaire at 12 months 12. Career and educational aspirations are measured using self-report questionnaire measures adapted from the RIPPLE Trial at 12 months

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026