An interventional study of comprehensive sex education in Adolescent Behavior, sponsored by Tehran University of Medical Sciences. Completed at 2 sites in Ghana. Open to female participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-06.
Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Prevention
The study is designed to assess the impact of an educational intervention program on the knowledge, attitude and behaviour towards pregnancy prevention based on Health Belief Model amongst adolescent girls in Northern Ghana. It is a randomised clustered controlled trial to be conducted on Senior High School students in Northern Ghana The study hypothesises that knowledge, attitude and behaviour of adolescents towards pregnancy prevention will differ between the groups.
Adolescent pregnancy is a global problem because of its health, social, economic and political repercussions on the globe. According to WHO about 16 million girls aged 15 to 19 and some 1 million girls under 15years give birth every year, mostly in low and middle-income countries. Babies born to adolescent mothers face a substantially higher risk of dying than those born to women aged 20 to 24. Pregnant adolescents also develop psychological problems from social stigma, suffering physical and domestic violence in her attempt to meeting the demands of pregnancy and childbearing. Children born to adolescents are at risk of malnutrition, low mental and physical development, inappropriate social connection with parents and poor education.
The factors associated with adolescent pregnancies include early marriages, poor social and economic support. Curiosity and peer pressure, lack of sexuality education, poor reproductive health services and poor attitude of health workers to providing contraceptive services for adolescents amongst others.
Ghana developed a number of policies to improve adolescent development through the provision of youth focus friendly health services in the country. However, adolescent pregnancy has not declined as expected.
The Health Belief Model is one of the appropriate health promotion models designed to predict preventive health behaviours, and it has enhanced preventive health behaviours in breast cancer screening and prevention of risky sexual behaviours in adolescents as well as prevention of iron deficiency anaemia. Schools are the best site for providing health education and promotion interventions because students spend most of the time in school and health promoters have the opportunity of reaching a large number of participants. Students of Senior High Schools in Ghana are adolescents and most of them are sexually active and has little knowledge about sex education and use of contraceptives. Therefore, providing comprehensive sex education to adolescents in schools will increase their knowledge; enhance their attitude and behavior towards pregnancy prevention.
This study, therefore, is intended to assess the impact of an educational intervention program on the knowledge, attitude and behavior towards pregnancy prevention based on Health Belief Model amongst adolescent girls in Northern Ghana.
The main objective is to assess the impact of an educational intervention program on knowledge, attitude and behavior towards pregnancy prevention based on Health Belief Model amongst adolescent girls in Northern Ghana.
Study design: The study shall be an interventional research using Clustered Randomized Controlled Trial to assess the impact of an educational program on the knowledge, attitude and behavior of adolescents towards teenage pregnancy using a researcher-structured questionnaire based on the Health Belief Model and a validated psychometric "Teen Attitude Pregnancy Scale" Intervention: A comprehensive sex education program shall be delivered in approximately six (6) sessions comprising of an introductory lesson on susceptibility and severity of teenage pregnancy, personal and community values, female reproductive system, contraceptives and decision-making. A qualified midwife shall conduct the health education program. Teaching and learning materials shall include flip charts, contraceptives, short videos, role-play scenarios among others. A practical demonstration, group discussion, lectures, role-play and interactive learning methods shall be employed. Attitudinal and behavioural intervention strategies shall be adopted for the study based on the Taxonomy of Behavior Change Techniques for interventions
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's enrollment of 363 is above the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
This group shall be given a comprehensive sex education in approximately six sessions.
Behavioral: comprehensive sex education
This group will not be given any form of education.
A comprehensive sex education program to be delivered in approximately six (6) sessions comprising of an introductory lesson on susceptibility and severity of teenage pregnancy, personal and community values, female reproductive system, contraception and decision-making skills.
Health Belief Model constructs
A questionnaire designed by the researchers based on the HBM six constructs shall be used to assess adolescents perception towards pregnancy prevention. A total of 58 items were used. The items specifically assess adolescents' opinion on their chances of getting pregnant; adolescents' opinion on the seriousness of adolescent pregnancy and the consequences of getting pregnant; adolescents' opinion on the importance delaying pregnancy, adolescents' opinion on the barriers of delaying pregnancy; and adolescents' confidence on their ability to delay pregnancy. The degree with which participants perceived each of these items were recorded using a five-point Likert's scale ranging from "strongly disagree for a lower score to strongly agree for a higher score". Each domain has the same minimum score of zero (0) and a maximum score of 40. All the scores for the HBM domain variables shall be expressed in percentages for analysis.
Time frame: 3 months and 6 months
Abstinence from sexual intercourse
Two (2) questions shall be used to assess abstinence practice. One question will assess participants' intention to abstain from sexual intercourse. Abstinence practice is a binary variable where a score of one (1) will be labelled "yes" and Zero (0) labelled "no". The question on intention is on a three-scale item; 1=definitely will, 2=not sure and 3=definitely won't. A score of one denotes low abstinence intention and a score of three denotes high abstinence intention. The intention scores shall be expressed in percentages for analysis.
Time frame: 3 months and 6 months
Plan to share: Yes — The data may be shared on request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 6 months after the study
Access criteria: If data is requested especially by journals it would be sent by email.
Ran from Feb 2018 to primary completion in Aug 2018, 6 months.
Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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