EFFECTS OF HEALTH EDUCATION INTERVENTION ON ADULTS' PERCEPTIONS, ATTITUDES AND SUPPORT FOR COMPREHENSIVE SEXUALITY EDUCATION PROGRAMME FOR ADOLESCENTS: A CLUSTER RANDOMIZED CONTROLLED TRIAL IN CROSS RIVER STATE, NIGERIA.

Last registered on May 17, 2023
View Trial History

Pre-Trial

Trial Information

General Information

Title
EFFECTS OF HEALTH EDUCATION INTERVENTION ON ADULTS' PERCEPTIONS, ATTITUDES AND SUPPORT FOR COMPREHENSIVE SEXUALITY EDUCATION PROGRAMME FOR ADOLESCENTS: A CLUSTER RANDOMIZED CONTROLLED TRIAL IN CROSS RIVER STATE, NIGERIA.
RCT ID
AEARCTR-0011189
Initial registration date
May 09, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 17, 2023, 2:14 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Nigeria
Region

Primary Investigator

Name
FIDELIS TAKIM OTU
Affiliation
UNIVERSITY OF CALABAR, CALABAR.
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
ANTOR ODU NDEP
PI Affiliation
UNIVERSITY OF CALABAR
Contact Investigator

Additional Trial Information

Status
Completed
Start date
2022-11-07
End date
2023-05-01
Keywords
Behavior
Additional Keywords
SEXUALITY, EDUCATION
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
As stated in various reports, any strong resistance or backlashed to sexuality education and condom and contraception availability programmes for adolescents in schools and communities from parents and community groups, is a real challenge that can prevent the development of policies and making of laws that will protect, maintain, and improve adolescents sexual and reproductive health. A community-based, cluster-randomized controlled trial (CRT) will be carried out to evaluate the effects of a health education intervention on adults’ knowledge, attitudes and support for comprehensive sexuality education, condom and contraceptives availability for adolescents in Cross River State, Nigeria. The study will consist of three phases:Phase 1: Pre-intervention (baseline) assessment Phase 2: health education intervention Phase 3: post-intervention assessment. The target population for this study will be all adult male and female parents or guardians, resident in Cross River State, Nigeria. The sample size for this study will be determined using the two Proportion estimation formula to be 346 ×2 = 692 for the two groups. Participants for the study will be recruited from 24 geographic clusters of approximately equal size mapped for the purpose of randomization. The clusters will be created based on geographic boundaries and population density. The twenty-four (24) selected clusters will then be randomized to intervention or control conditions of three (3) arms - intervention: mixed teaching methods (8), single teaching method (8); and control (8), through the generation of random allocation sequence using random number generated programme. The instrument that will be used to collect data for this study will be a semi-structured validated Questionnaire. Data that will be collected will be double entered in standard spreadsheets separately for the purpose of quality. Descriptive and inferential statistics of the entered data will be analyzed using Statistical Package for Social Sciences (SPSS) software, version 26.0.
External Link(s)

Registration Citation

Citation
NDEP, ANTOR ODU and FIDELIS TAKIM OTU. 2023. "EFFECTS OF HEALTH EDUCATION INTERVENTION ON ADULTS' PERCEPTIONS, ATTITUDES AND SUPPORT FOR COMPREHENSIVE SEXUALITY EDUCATION PROGRAMME FOR ADOLESCENTS: A CLUSTER RANDOMIZED CONTROLLED TRIAL IN CROSS RIVER STATE, NIGERIA.." AEA RCT Registry. May 17. https://doi.org/10.1257/rct.11189-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2022-12-05
Intervention End Date
2022-12-19

Primary Outcomes

Primary Outcomes (end points)
Positive perception, Positive attitude, and Increased support for Comprehensive Sexuality Education Programme.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
A community-based, cluster-randomized controlled trial (CRT) will be carried out to evaluate the effects of a health education intervention on adults’ perceptions, attitudes and support for comprehensive sexuality education, condom and contraceptives availability for adolescents in Cross River State, Nigeria. The study will consist of three phases:
Phase 1: Pre-intervention (baseline) assessment
Phase 2: health education intervention
Phase 3: post-intervention assessment
The pre-intervention assessment will include information on socio-demographic characteristics of the participants, including gender, educational level, religious faith, residence; as well as information about perceptions, attitudes and support for comprehensive sexuality education, condom and contraceptives availability for adolescents. The health education intervention will then be implemented. These will then be followed by a post-intervention assessment which will be designed to ascertain if there will be development of positive perception and attitude and support for comprehensive sexuality education, condom and contraceptives availability for adolescents.
Experimental Design Details
Randomization Method
Generation of random allocation sequence using random number generated programme (https://www.randomizer.org) with the help of simple randomization techniques.
Randomization Unit
Villages/Streets
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
24 villages/streets
Sample size: planned number of observations
24 clusters participants (692 adults) i.e., 29 adults per cluster
Sample size (or number of clusters) by treatment arms
12 clusters (346 adults) control; 12 clusters (346 adults) health education intervention.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
THE CROSS RIVER STATE HEALTH RESEARCH ETHICS COMMITTEE (CRS-HREC)
IRB Approval Date
2022-02-08
IRB Approval Number
CRSMOH/RP/REC/2022/230
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials