NCT03384251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

November 6, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

December 16, 2017

Last Update Submit

November 4, 2018

Conditions

Keywords

Adolescent pregnancyTeenage pregnancyPreventionGhana

Outcome Measures

Primary Outcomes (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.

    3 months and 6 months

Secondary Outcomes (1)

  • Abstinence from sexual intercourse

    3 months and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

This group shall be given a comprehensive sex education in approximately six sessions.

Behavioral: comprehensive sex education

Control group

NO INTERVENTION

This group will not be given any form of education.

Interventions

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.

Intervention group

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female adolescents are to participate in this study
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kalpohin Senior High School

Tamale, Northern Region, 00233, Ghana

Location

Vittin Senoir High School

Tamale, Northern Region, Ghana

Location

Related Publications (11)

  • 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.

    PMID: 24641534BACKGROUND
  • 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.

    PMID: 24558785BACKGROUND
  • 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.

    PMID: 16615840BACKGROUND
  • 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.

    PMID: 26700638BACKGROUND
  • 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.

    PMID: 27080996BACKGROUND
  • 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.

    PMID: 22590892BACKGROUND
  • 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.

    PMID: 11145370BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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/.

    RESULT
  • 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.

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ibrahim Yakubu

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants are not required to write their names on the questionnaires. therefore responses provided are anonymous
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2017

First Posted

December 27, 2017

Study Start

February 20, 2018

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

November 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

The data may be shared on request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations