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Adolescent BehaviorNCT03384251

Assessing an Educational Intervention Program on Knowledge, Attitude and Behaviour Towards Pregnancy Prevention Based on Health Belief Model Amongst Adolescent Girls in Northern Ghana

A study testing comprehensive sex education in people with Adolescent Behavior, run by Tehran University of Medical Sciences at 2 sites in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for
Adolescent Behavior
What is being tested?
comprehensive sex education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363 participants
Where
2 sitesGhana
Study dates
20 Feb 2018to 30 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Only unmarried adolescent female high school students shall be included in the study.

Who cannot join

  • Girls who do not want to participate and those who do not fall within the adolescent age group as well as married adolescents shall be excluded

Trial locations and contacts

2 sites in 1 country.

Ghana2 sites

  • Kalpohin Senior High School

    Tamale, Northern Region, 00233

  • Vittin Senoir High School

    Tamale, Northern Region

Other trials in Ghana

About this study

Official title: Assessing an Educational Intervention Program on Knowledge, Attitude and Behaviour Towards Pregnancy Prevention Based on Health Belief Model Amongst Adolescent Girls in Northern Ghana: A Clustered Randomized Trial

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.

Read the detailed description

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

Being tested
comprehensive sex education
Keywords
Adolescent pregnancy, Teenage pregnancy, Prevention, Ghana
Medical subject headings
Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • comprehensive sex educationBehavioural

    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.

Study groups in NCT03384251
Study groupRoleWhat they receive
Intervention groupExperimentalThis group shall be given a comprehensive sex education in approximately six sessions.
Receives: Behavioral: comprehensive sex education
Control groupNo interventionThis group will not be given any form of education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months and 6 months

Secondary outcomes (1)

  1. 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.

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2017
  2. Study start20 Feb 2018
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multi-stage sampling method shall be conducted. A random sampling of six (6) out 12 mixed Senior High Schools in Tamale Metropolis-Northern Ghana would be selected. We shall randomly allocate three (3) schools as the intervention and the other three (3) as control groups respectively. In each school, one class shall be selected at random from each grade in both intervention and control groups.
Masking
None (open label)
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03384251
Sponsor's protocol ID
IR.TUMS.SPH.REC.1396.4089
Other IDs
GHS-ERC:020-03-18
Status last verified
Sep 2018
First submitted
16 Dec 2017
Last updated
6 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data may be shared on request.

Publications

  • Ganchimeg T, Ota E, Morisaki N, Laopaiboon M, Lumbiganon P, Zhang J, Yamdamsuren B, Temmerman M, Say L, Tuncalp O, Vogel JP, Souza JP, Mori R; WHO Multicountry Survey on Maternal Newborn Health Research Network. Pregnancy and childbirth outcomes among adolescent mothers: a World Health Organization multicountry study. BJOG. 2014 Mar;121(Suppl 1):40-8. doi: 10.1111/1471-0528.12630.

    PubMed 24641534

  • Aransiola JO, Asa S, Obinjuwa P, Olarewaju O, Ojo OO, Fatusi AO. Teachers' perspectives on sexual and reproductive health interventions for in-school adolescents in Nigeria. Afr J Reprod Health. 2013 Dec;17(4):84-92.

    PubMed 24558785

  • Atuyambe L, Mirembe F, Johansson A, Kirumira EK, Faxelid E. Experiences of pregnant adolescents--voices from Wakiso district, Uganda. Afr Health Sci. 2005 Dec;5(4):304-9. doi: 10.5555/afhs.2005.5.4.304.

    PubMed 16615840

  • Ahorlu CK, Pfeiffer C, Obrist B. Socio-cultural and economic factors influencing adolescents' resilience against the threat of teenage pregnancy: a cross-sectional survey in Accra, Ghana. Reprod Health. 2015 Dec 23;12:117. doi: 10.1186/s12978-015-0113-9.

    PubMed 26700638

  • Krugu JK, Mevissen FE, Prinsen A, Ruiter RA. Who's that girl? A qualitative analysis of adolescent girls' views on factors associated with teenage pregnancies in Bolgatanga, Ghana. Reprod Health. 2016 Apr 14;13:39. doi: 10.1186/s12978-016-0161-9.

    PubMed 27080996

  • Abdul-Rahman L, Marrone G, Johansson A. Trends in contraceptive use among female adolescents in Ghana. Afr J Reprod Health. 2011 Jun;15(2):45-55.

    PubMed 22590892

  • Adinma JI, Agbai AO, Okeke AO, Okaro JM. Contraception in teenage Nigerian school girls. Adv Contracept. 1999;15(4):283-91. doi: 10.1023/a:1006732222373.

    PubMed 11145370

  • Somers CL, Johnson SA, Sawilowsky SS. A measure for evaluating the effectiveness of teen pregnancy prevention programs. Psychology in the Schools. 2002;39(3):337-42.

  • Yidana A, Ziblim S-D, Azongo TB, Abass YI. Socio-Cultural Determinants of Contraceptives Use Among Adolescents in Northern Ghana. Public Health Research. 2015;5(4):83-9.

  • World Health Organization: Adolescent pregnancy Fact sheet [Internet]. World Health Organization. 2014 [cited September 2014]. Available from: http://www.who.int/mediacentre/factsheets/fs364/en/.

  • Yakubu I, Garmaroudi G, Sadeghi R, Tol A, Yekaninejad MS, Yidana A. Assessing the impact of an educational intervention program on sexual abstinence based on the health belief model amongst adolescent girls in Northern Ghana, a cluster randomised control trial. Reprod Health. 2019 Aug 15;16(1):124. doi: 10.1186/s12978-019-0784-8.

    PubMed 31416450

Questions about this trial

What is this clinical trial studying?

A study testing comprehensive sex education in people with Adolescent Behavior, run by Tehran University of Medical Sciences at 2 sites in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Belief Model constructs (time frame: 3 months and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03384251, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.

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