Evaluation study to examine the effectiveness of Longlivelove-4, a teacher-delivered sexual health program
| ISRCTN | ISRCTN11754581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11754581 |
| Protocol serial number | 051.90051 |
| Sponsor | TNO |
| Funder | ZonMw (Netherlands Organisation for Health Research and Development), funding number 12427 0003 |
- Submission date
- 23/04/2018
- Registration date
- 13/06/2018
- Last edited
- 23/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Compared to other Western countries contraceptive use and condom use is high among young people (aged 12-24) in the Netherlands. Nevertheless, early starters and low educated young people are more likely to be at risk for unprotected sex, and the risk for unprotected and unsatisfactory sex is higher when first time sexual intercourse is unexpected.
This study aims to evaluate the effectiveness of a teacher-delivered comprehensive sexual health education program, LongLiveLove (LLL4, fourth edition).
Who can participate?
Students and teachers in the second class at participating schools
What does the study involve?
Schools are randomized to one of three intervention conditions:
1. The control condition, where learners would receive regular sexual education
2. The LLL4 experimental condition
3. The LLL4 condition + Teacher coaching
LLL4 is a newly developed teacher-led comprehensive sexual health curriculum. In six lessons learners are taught about different sexual health themes: sexual maturation, sexual preferences and boundaries, sexual transmitted diseases, pregnancy and safer sexual practices, sexual diversity. Three types of materials are used as part of the lessons: A magazine for students consisted of 6 chapters, each representing a lesson. The magazine was developed to provide students with information about themes that are discussed during the lessons. It contains role model stories with personal experiences, photo’s, a photo story, quizzes, recommendations and a cartoon geared to the students’ perception of their environment. A digital manual for teachers consists of a set-up and style example for each lesson. Both the magazine for students and the manual for teachers had two versions, one for theoretical pre-vocational secondary education, senior general secondary education and pre-university education, and one for practical training and practical pre-vocational secondary education. The second version contains less text, bigger letters and more practical tasks. A DVD for pupils contained 6 episodes of 7 minutes, one for each lesson. An additional episode discussed teenage motherhood. The DVD was developed to stimulate discussion and to teach skills. Each episode consists of a docudrama, animations, statements of adolescents about themes and interviews with adolescents.
Teacher coaching
The teachers in the teacher coaching conditions were offered additional support via a website (Teachinglove.nl) that addressed common challenges of teachers in delivering sexual health education.
What are the possible benefits and risks of participating?
There are no direct benefits or risk for participants.
Where is the study run from?
1. TNO, Research Group Child Health (Netherlands)
2. 59 participating schools
When is the study starting and how long is it expected to run for?
September 2011 to November 2013
Who is funding the study?
Netherlands Organisation for Health Research and Development (Netherlands)
Who is the main contact?
Dr Pepijn van Empelen (scientific)
pepijn.vanempelen@tno.nl
Contact information
Scientific
TNO
Research Group Child Health
Schipholweg 77-89
Leiden
2316 ZL
Netherlands
 ORCID ID |
0000-0002-9809-7650 |
|---|---|
| Phone | +31 (0)88 866 27 11 |
| pepijn.vanempelen@tno.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster-randomised controlled trial with three arms |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of the Long Live Love 4, a comprehensive sexual health program for 13- and 14-year-old secondary school students in the Netherlands: a cluster-Randomized Controlled Trial |
| Study objectives | It is hypothesized that students exposed to Long live love 4, compared to the control group, will result in improved sexual health outcomes. At teacher-level: It was expected that teachers that receive the LLL+eCoach (LLL4+) compared to the teachers that only received LLL4 (without eCoach) would show higher quality of implementation of LLL4. |
| Ethics approval(s) | Psychology Ethics Committee (ECP) of Maastricht University, 06/01/2012, ref: ECP 109 8_12_2011 |
| Health condition(s) or problem(s) studied | Sexual health |
| Intervention | There are three intervention arms: 1. Control condition (receives conventional sex education) 2. Long live love (without eCoach) experimental condition: receives the newly developed comprehensive sexual health program, which include six lessons; it consists of a magazine and DVD for adolescents, a teachers manual, condoms, posters and a question box. 3. LLL4 with eCoach condition: LLL4 program, but in addition a website with e-coaching material is developed for teachers (Teachinglove.nl) that addresses common challenges of teachers in delivering sexual health education. LLL4 is a series of six lessons; it consists of a magazine and DVD for adolescents, a teachers manual, condoms, posters and a question box. Teachers can choose between 1-2 lessons per week (lessons are one class hour (i.e., 50 minutes). Hence, total duration is 3-6 weeks (total duration approximately 5 hours). Themes discussed within the different lessons: Lesson 1) Sexual maturation: what happens to you? Puberty, being in love, sexual identity, influence of parents and friends, and homosexuality; • Lesson 2) Sexual maturation: which stage have you reached? Making eyes, courting, breaking up, love sickness, choices in relationship and ways for intimacy; • Lesson 3) Preferences and boundaries: what are your boundaries? Discovering and communicating your and others’ preferences and boundaries, safe internet use, unpleasant experiences, loverboys; Lesson 4) Preferences and boundaries: how to make the best out of sex? First time having sex, conditions for having safe, preferable and pleasant sex, dealing with sexual problems, information and help seeking; Lesson 5) Safe sex: what is it? Preventing pregnancy and STI’s, (un)safe sex and what to do; Lesson 6) Safe sex: how to do it? Use of contraception, condom use, communication about it and dealing with resistance against condom use. The lessons were developed to transfer knowledge, to promote a positive attitude towards sex and to practice with skills. As part of the intervention the following materials were available: • The magazine for students consisted of 6 chapters, each representing a lesson. The magazine was developed to provide students with information about themes that will be discussed during the lessons. It contained role model stories with personal experiences, photo’s, a photo story, quizzes, recommendations and a cartoon geared to the students’ perception of their environment. • A digital manual for teachers consisted of a set-up and style example for each lesson. Both the magazine for students and the manual for teachers had two versions, one for theoretical pre-vocational secondary education, senior general secondary education and pre-university education, and one for practical training and practical pre-vocational secondary education. The second version contained less text, bigger letters and more practical tasks. • The DVD for pupils contained 6 episodes of 7 minutes, one for each lesson. An additional episode discussed teenage motherhood. The DVD was developed to stimulate discussion and to teach skills. Each episode consisted of a docudrama, animations, statements of adolescents about themes and interviews with adolescents. eCoach (Teachinglove.nl) Teachinglove.nl contains video’s, hands-on examples and recommendations of other teachers, a teachers manual and worksheets, and teachers could participate in a quiz, ask questions and exchange experiences. It specifically addresses 7 challenges: 1. creating a safe and trusted environment for the provision of sexual health lessons, 2. teaching about sexual health without shame, 3. protecting boundaries in sharing personal information and questions between teachers and students and among students themselves, 4. identifying personal problems of students, 5. integrating social media, 6. integrating homosexuality as self-evident during the lessons of LLL and dealing with negative reactions to homosexuality 7. anticipating differences in culture and levels of sexual experience in the classroom. Randomization takes place at school level. Schools were stratified with the aim to ensure a match in terms of educational level, religious background, and region. In order to assess the differences between the two LLL4 conditions, twice as many schools are allocated to these conditions, as compared to the control condition (with a ratio of 2:2:1). The experimental intervention is delivered by (trained) teachers. The teachers in the LLL4+ condition are offered a web-based eCoach (‘Teachinglove.nl’). Quality of implementation, between the two experimental conditions is also compared at teacher-level. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Determinants of sexual health related behaviors of the students are measured using previously validated paper-and-pencil questionnaires at baseline, and 1 month and 8 months after delivery of LLL4: |
| Key secondary outcome measure(s) |
1. Knowledge regarding sex and perceived risk including STI and unwanted pregnancy is assessed using a previously validated paper-and-pencil questionnaire at baseline, 1 month and 8 months. |
| Completion date | 01/11/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 3990 |
| Key inclusion criteria | Students: 1. Students from the second class of secondary vocational school 2. Aged 13-14 years Teachers: 1.Teaching 2nd class of secondary vocational school |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 09/01/2012 |
| Date of final enrolment | 01/05/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden
2316
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/06/2018 | 23/11/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/11/2020: Publication reference added.
