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Clinical Trials/NCT02686736
NCT02686736CompletedNot Applicable

Evaluation of the Effect of an Internet-based Educational Intervention to Prevent Risky Sexual Behaviors in Mexican Adolescents

Coordinación de Investigación en Salud, Mexico0 sites456 target enrollmentStarted: January 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
456
Primary Endpoint
Change from baseline in attitudes regarding condom use at 1 and 4 months measured by the University of California, Los Angeles Multidimensional Condom Attitudes Scale

Study Overview

Brief Summary

The objective of this study is to design and evaluate an internet-based educational strategy to prevent sexual risk behaviors in Mexican adolescents. Methods: A field trial with one intervention and one comparison group, with ex-ante and ex-post measurements will be conducted in 2 public secondary schools. Adolescents between 14 and 15 years of age will participate. The intervention will be conducted in one school and the other school will serve as a comparison group, where investigators will observe the usual sexual education that the school provides. The intervention will be delivered through an internet web page; it includes four educational sessions that will be provided during a four-week period. The follow up will last three-months. The information on the study variables will be obtained through an internet-based self-applied questionnaire and collected on three occasions: when the adolescents enters to the study (baseline), once intervention is completed (at one month) and after three months of follow-up (at fourth month).

Detailed Description

The conceptual framework for the intervention and educational materials was based on the model of the Information-Motivation-and-Behavioral-Skills proposed by Fisher and Fisher, 2000. This model emphasizes that adequate information regarding risk sexual behavior, changing the motivational component and training in behavioral skills can influence initiation and maintenance of protective sexual behaviors.

The research group that was constituted by a pediatrician, a psychologist, and a sociologist, designed the educational materials. All the research team members have experience in educational interventions. The academic basis to develop the materials were two books titled: "You, your life, your dreams" developed by International Family Care (2007) and "Your future in freedom, for responsible sexuality and reproductive health" published by the Government of the Federal District and the Secretary of Education of the Federal District of Mexico City (2008). Investigators also took into account the statistics on the sexually transmitted diseases and adolescents' pregnancies of the World Health Organization, 2012 National Health and Nutrition survey, the National Register of AIDS cases, and information from the Planned Parenthood Federation of America.

Investigators designed teen-friendly educational materials, to do so, investigators used "avatars" from www.bitstrips.com, which are the comics for teenagers. Investigators created two central characters a teenage boy and a teenage girl who present the information in the form of dialogs and talk about their own and friend's experiences.

Two experts in the area of adolescents' sexual and reproductive health reviewed the educational materials; then, 20 adolescents between 14 and 15 years participated in three rounds of pilot testing. Both, the teenagers and their parents accepted to participate in this phase through verbal informed consent.

Investigators used the snowball sampling technique to choose the teenagers that took part in the pilot phase, which included ten boys and ten girls, with an average grade point of 8.5 (range 8.0-9.0). Their families were of different types (nuclear, single-parent, extended), and their parents had varying levels of education. Most adolescents (18) had not begun sexual activity, and only two reported being sexually active. Experts and teens were asked if the educational information was clear, understandable and if it used appropriate language for teens, or if it was contradictory, uncomfortable, or boredom. The teens were asked to evaluate whether they liked or not each educational session (using a scale of 1 to 3, where 1 = No, I do not like it, 2 = I like it more or less, 3 = I like it) and to explain why they disliked the educational information. The final version of the educational material was produced taking into account the comments and suggestions of experts and teens, which rated the information highly. Although most adolescents who participated in the pilot testing had not started their sexual life, they reported that the information was clear and interesting.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
14 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adolescents between 14 and 15 years of age, who are in the third year of public secondary schools and attend to schools that were selected through simple random sampling from the list of public secondary schools in the Iztapalapa Delegation in Mexico City
  • Who agree to participate through informed consent; also, their parents must sign the written informed consent.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline in attitudes regarding condom use at 1 and 4 months measured by the University of California, Los Angeles Multidimensional Condom Attitudes Scale

Time Frame: Baseline, 1 month, and 4 months

Attitudes regarding condom use will be measured by the University of California, Los Angeles Multidimensional Condom Attitudes Scale.

Secondary Outcomes

  • Change from baseline in knowledge of sexually transmitted infections at 1 and 4 months measured by the scale validated in Mexican teens by Robles-Montijo and Diaz-Loving(Baseline, 1 month, and 4 months)
  • Change from baseline in self-efficacy toward consistent condom use at 1 and 4 months assessed by the seven measures proposed by Fishbein and colleagues(Baseline, 1 month, and 4 months)

Investigators

Sponsor
Coordinación de Investigación en Salud, Mexico
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Svetlana Doubova

Head of the Epidemiology and Health Services Research Unit

Coordinación de Investigación en Salud, Mexico

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