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

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ClinicalTrials.gov Identifier: NCT03384251
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ibrahim Yakubu, Tehran University of Medical Sciences

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Adolescent Behavior Behavioral: comprehensive sex education Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: Participants are not required to write their names on the questionnaires. therefore responses provided are anonymous
Primary Purpose: Prevention
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
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Arm Intervention/treatment
Experimental: Intervention group
This group shall be given a comprehensive sex education in approximately six sessions.
Behavioral: comprehensive sex 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.

No Intervention: Control group
This group will not be given any form of education.



Primary Outcome Measures :
  1. Health Belief Model constructs [ Time Frame: 3 months and 6 months ]

    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.



Secondary Outcome Measures :
  1. Abstinence from sexual intercourse [ Time Frame: 3 months and 6 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female adolescents are to participate in this study
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384251


Locations
Ghana
Kalpohin Senior High School
Tamale, Northern Region, Ghana, 00233
Vittin Senoir High School
Tamale, Northern Region, Ghana
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Ibrahim Yakubu Tehran University of Medical Sciences

Publications of Results:
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/.

Other Publications:
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.

Responsible Party: Ibrahim Yakubu, Principal Investigator, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03384251     History of Changes
Other Study ID Numbers: IR.TUMS.SPH.REC.1396.4089
GHS-ERC:020-03-18 ( Other Identifier: Ghana Health Service Ethics Review Committee )
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data may be shared on request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after the study
Access Criteria: If data is requested especially by journals it would be sent by email.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ibrahim Yakubu, Tehran University of Medical Sciences:
Adolescent pregnancy
Teenage pregnancy
Prevention
Ghana