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Adolescent BehaviorNCT02686736

Internet-based Intervention to Prevent Risky Sexual Behaviors in Mexican Adolescents

A study testing Internet-based educational intervention in people with Adolescent Behavior, run by Coordinación de Investigación en Salud, Mexico.

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 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. Read more about this study

Who is it for?
Ages 14 to 15 years
Conditions the study is for
Adolescent Behavior
What is being tested?
Internet-based educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
No sites listed yet
Study dates
Jan 2016to 1 Jul 2016
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 14 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • None

About this study

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

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).

Read the 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.

Description and evaluation of the intervention The study materials are available on the Internet web page (http://tu-ssexual.com), which can be accessed with the participant e-mail address and a centrally assigned password.

The intervention will include an introduction and four educational sessions and will last one month (one session per week) followed by a three-month follow-up. Teens will be allowed to access to a weekly session at any time and as often as he/she likes. However, the sessions will be consecutive, so teens cannot be able to access to the next session without finishing the previous one. Each session has the duration of one hour on average and ends with overview questions. Additionally, at the end of the each session teens will be asked ¿what they like and dislike about the session? And the answers will be recorded in the study database.

Furthermore, during the intervention and follow-up booster e-mail messages will be sent to the teens of the intervention group. "Booster messages" will emphasize main points of the educational sections and will be sending 2-3 per week from the second week of the intervention.

Information on the study variables will be obtained through the internet-based self-applied questionnaire and collected on three occasions: when the adolescents enters into the study (baseline), once the intervention is completed (at one month) and after three months of follow-up (fourth month).

Being tested
Internet-based educational intervention
Keywords
internet-based educational intervention, risky sexual behaviors, prevention
Medical subject headings
Adolescent Behavior

What participants receive

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

  • Internet-based educational interventionBehavioural

    The intervention will include four educational sessions about risky sexual behaviors and its prevention. The intervention will last one month (one session per week) followed by a three-month follow-up. Teens will be allowed to access to a weekly session at any time and as often as he/she likes.

Study groups in NCT02686736
Study groupRoleWhat they receive
Internet-based educational interventionOtherThe Internet-based educational intervention will include four educational sessions that will be provided during a four-week period. The follow up will last three-months.
Receives: Behavioral: Internet-based educational intervention
Control groupNo interventionIn the control group, teens will continue the usual school provided sexual education and will be invited to answer the internet-based self-applied questionnaire at the same time as the intervention group.

What is being measured

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

  1. 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

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

    Measured: Baseline, 1 month, and 4 months

Secondary outcomes (2)
  1. 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

    Knowledge of sexually transmitted infections will be measured by the scale validated in Mexican teens by Robles-Montijo and Diaz-Loving.

    Measured: Baseline, 1 month, and 4 months

  2. 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

    Self-efficacy toward consistent condom use will be assessed by the seven measures proposed by Fishbein and colleagues.

    Measured: Baseline, 1 month, and 4 months

Timeline

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

  1. First posted19 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion1 Jul 2016
  4. Study completion1 Jul 2016

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686736
Sponsor's protocol ID
R 2014-785-033
Status last verified
Jan 2017
First submitted
11 Feb 2016
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Doubova SV, Martinez-Vega IP, Infante-Castaneda C, Perez-Cuevas R. Effects of an internet-based educational intervention to prevent high-risk sexual behavior in Mexican adolescents. Health Educ Res. 2017 Dec 1;32(6):487-498. doi: 10.1093/her/cyx074.

    PubMed 29177452
  • Doubova SV, Infante-Castaneda C, Perez-Cuevas R. Internet-based educational intervention to prevent risky sexual behaviors in Mexican adolescents: study protocol. BMC Public Health. 2016 Apr 18;16:343. doi: 10.1186/s12889-016-2990-4.

    PubMed 27089870

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based educational intervention in people with Adolescent Behavior, run by Coordinación de Investigación en Salud, Mexico.

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 2 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

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). 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 NCT02686736, which also lists 2 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 31 Jan 2017.

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