"Educational Intervention 'Be Yourself': Digital Innovation to Prevent Teenage Pregnancy"

NCT06824922 | Not Yet Recruiting DMC

• 2 other identifiers: Autonomous University of NuevoNo. Registro: FAEN-D-2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Adolescent pregnancy and early initiation of sexual activity is a serious global public health problem, every year, around sixteen million adolescents between 15 and 19 years of age give birth, representing 11% of all births globally. Objective: To design a protocol of a pilot Randomized Controlled Trial to evaluate the preliminary efficacy of the "Be Yourself" intervention to increase self-determined motivation to prevent pregnancy in adolescents in secondary education. Methods: The protocol was developed based on the Protocol Items: ecommendations for Interventional Trials 2013 (SPIRIT2013) Statement, in the City of Monterrey, Nuevo León, Mexico in 2023. Results: The protocol outlined the design of the intervention, structured the content of the sessions using a logic model of intervention, and developed manuals for program facilitators and guides for participants. In addition, a website and a chatbot with Artificial Intelligence were developed, and the strategy for the application of the evaluation instruments was established. Conclusion: The educational intervention "Be yourself" is projected as a promising program to promote self-determined motivation and prevent adolescent pregnancy.

Conditions

Prevenir el Embarazo Adolescente

Keywords

Self-determination; Teenage Pregnancy; Sexual behaviour; Prevention; Randomized controlled trial

Outcome Measures

Primary Outcomes (5)

• Increased rates of Self-Determined Motivation to prevent teenage pregnancy

  Change in levels of self-determined motivation for adolescent pregnancy prevention will be assessed using context-specific psychometric tools. It is expected that the intervention will increase intrinsic motivation and encourage responsible sexual decision-making. For this measurement, the Behavioral Regulation in Exercise Questionnaire (BREQ-3), originally developed to assess motivation in physical activity and subsequently adapted to the Mexican context to measure behavioral regulation in pregnancy prevention, will be used. The peer-reviewed adaptation retained its psychometric validity. The questionnaire uses a five-point Likert scale and calculates self-determined motivation using the Self-Determination Index (SDI) with the following formula: 3 \* intrinsic regulation) + (2 \* integrated regulation) + (1 \* identified regulation) - (1 \* introjected regulation) - (2 \* external regulation) - (3 \* no motivation), with reliability reported in different studies.

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Increase in the Level of Knowledge about Pregnancy Prevention

  The Sexual and Reproductive Health Knowledge Scale will be used to assess the level of knowledge in this area. The instrument, originally composed of 128 items, addresses four dimensions: sexual health, reproductive health, HIV/AIDS and STIs, and condom use. For this study, 29 items were selected from the dimensions of sexual health, reproductive health and condom use. The responses follow a Likert-type scale with options: true (1), false (2) and don't know (8), although in some items the "true" and "false" scores are reversed. For the analysis, the "don't know" option will be recoded as 0, and the correct answers as 1, establishing a dichotomous scale (0-1), where higher scores indicate a higher level of knowledge.

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Improving Communication on Sexual Issues

  This outcome will be assessed using the Communication about Sexual Issues with Parents, Friends, and Partners Instrument, focusing on pregnancy prevention. Six of the original nine items will be used. The response scale is a five-point Likert scale (1 = not at all, 5 = very much), with a total score from 6 to 30, where higher values indicate greater perceived communication. The information received on reproduction, contraception, condom use and social pressure in sexual relations will be analyzed. An increase in the quality and frequency of these interactions is expected, favoring informed decision making.

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Change in Life Goals

  The Aspirations Index Instrument will be used to evaluate the importance of life goals in adolescents, considering both extrinsic goals (wealth, fame, image and power) and intrinsic goals (relationships, personal growth, social contribution, self-expression and mastery). The questionnaire, previously adapted to the Mexican context, will have 51 items and will be applied using a seven-point Likert scale (1 = not at all important, 7 = very important). Higher scores will reflect a greater importance given to personal aspirations. It is expected that the application of this instrument will provide reliable results, supported by previous studies that have reported.

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Satisfaction of Basic Psychological Needs: autonomy, relationships and competence.

  The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) will measure adolescents' perceptions of satisfaction and frustration of their needs for autonomy, competence and relationships in the context of pregnancy prevention. The instrument uses a Likert scale from 1 (totally false) to 5 (totally true), where higher satisfaction scores indicate greater well-being, while higher frustration scores reflect greater discomfort. For this study, the version adapted and validated in adolescents will be used, with high correlations in satisfaction and frustration, which supports its internal consistency and validity in the measurement of these factors.

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

Secondary Outcomes (4)

• Risk and Protective Intention

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Sexual behavior in relation to teenage pregnancy prevention.

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Pregnancy prevention sexual behavior Pregnancy

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

• Process of sexual behavior change in adolescents

  It will be evaluated before the intervention (pretest 1), after completing the intervention (posttest 2) and 3 months after follow-up.

Other Outcomes (1)

• Evaluation of System Usability in the "Be Yourself" Intervention

  Perceived usability of the 'Be Yourself' website and its chatbot will be assessed at the end of the intervention group sessions (around week 8), and again at the 3-month follow-up (approximately week 20).

Study Arms (2)

Educational Intervention "Be yourself"

EXPERIMENTAL

The experimental group will receive the educational intervention "Be Yourself", designed to prevent sexual risk in high school adolescents through self-determined motivation. This intervention is based on the MACSPEA model, competency-based learning and stages of change, and uses an interactive web page and a chatbot for follow-up and activities. Intervention: The intervention consists of three interactive educational sessions: Session One: Introduction to self-determined motivation and key aspects of sexuality, including anatomy, physiology, and sexual health. Session two: Exploration of sexual goals, values and communication, using role-plays and activities to strengthen decision-making and problem-solving skills. Third session: Focus on motivation for healthy decision making and prevention of pregnancy and STIs, with a follow-up session via website and chatbot. Duration: Each session lasts 60 minutes, for a total of 10 hours and 20 minutes of intervention.

Behavioral: "Be yourself", educational intervention with chatbot to promote self-determined motivation and prevent adolescent pregnancy: pilot trial protocol

Control Group (CG) - Conventional Sex Education

ACTIVE COMPARATOR

The control group will receive conventional sex education, which focuses on the transmission of knowledge about anatomy, physiology and contraceptive methods, as well as self-care of sexual health. Intervention: Two theoretical sessions of one hour each will be given: First session: orientation on sexual health, contraceptive methods and teen pregnancy prevention, through a PowerPoint presentation. Second session: Development of sexual health self-care skills, with emphasis on informed decision making and self-respect. Duration: Each session lasts 60 minutes, for a total of 2 hours of intervention.

Other: Conventional Sex Education

Interventions

"Be yourself", educational intervention with chatbot to promote self-determined motivation and prevent adolescent pregnancy: pilot trial protocol BEHAVIORAL

The "Be Yourself" educational intervention stands out for its focus on self-determined motivation and teen pregnancy prevention. Unlike traditional interventions, which focus on transmitting information, this intervention promotes adolescent autonomy in making responsible sexual decisions. It uses interactive technology such as a web page and a chatbot, which provide personalized follow-up and reinforcement activities between sessions, encouraging active participation. It also employs competency-based learning, which strengthens practical and emotional skills, such as effective communication and problem solving. Sessions include role-plays and practical activities to apply what has been learned. This comprehensive approach and the use of digital platforms distinguish "Be Yourself" from other interventions, offering continuous and personalized accompaniment to reinforce learning throughout the process.

Educational Intervention "Be yourself"

Conventional Sex Education OTHER

For the CG, two theoretical sessions are planned. In the first, an orientation on adolescent sexual health will be provided through a one-hour PowerPoint presentation. Topics of anatomy, physiology, biological changes in adolescence and contraceptive methods will be addressed, highlighting their proper use and the prevention of adolescent pregnancy. The second session, also lasting one hour, will develop sexual health self-care skills, discussing the importance of self-care, self-respect and informed decision making. There will be a question and answer session to address concerns and reflect on how self-care contributes to a healthy and safe sexual life.

Control Group (CG) - Conventional Sex Education

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents between 11 and 15 years of age enrolled in public high schools in Nuevo León will be included.
• public high schools in Nuevo León.
• Be male or female, regardless of whether they have initiated their sexual life. sexually active.
• Have access to a computer room with internet to use the web page and the interventions chatbot.
• the interventions chatbot.
• Live at the same address with their parents or legal guardian.

You may not qualify if:

• Have previously participated in a similar sexuality intervention.
• Have cognitive or developmental difficulties that impede their understanding of the intervention and use of the technology platform, including people with
• Autism Spectrum Disorder (ASD) at levels that affect functional communication, Attention Deficit Hyperactivity Disorder (ADHD) with severe attention difficulties, or those who cannot read and write.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Autonomous University of Nuevo Leon

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (1)

• Ryan RM, Deci EL. Self-Determination Theory: Basic Psychological Needs in Motivation, Development, and Wellness. Guilford Publications; 2018.

  BACKGROUND

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Natanael Librado González, Master

  Universidad Autónoma de Nuevo León

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natanael Librado González, Master's

CONTACT

(+52) 9512892149; nlibrado3@gmail.com

Dora J Onofre Rodríguez, PhD

CONTACT

(+52) 8115312287; donofre64@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science in Nursing

Model Details: This Pilot Randomized Controlled Trial with a parallel intervention model, where one group receives the educational intervention "Be Yourself" and the other receives conventional sex education. It uses an Open Label design and has a preventive purpose (Prevention).

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 13, 2025
• Study Start: February 6, 2025
• Primary Completion: April 6, 2025
• Study Completion: June 6, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)