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临床试验/NCT06824922
NCT06824922尚未招募不适用

Be Yourself" Educational Intervention With Web Page and Chatbot to Promote Self-determined Motivation and Prevent Teenage Pregnancy: Pilot Trial.

Universidad Autonoma de Nuevo Leon1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Increased rates of Self-Determined Motivation to prevent teenage pregnancy

研究概览

简要总结

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.

详细描述

Background and Rationale Adolescent pregnancy is a critical global public health issue, with approximately 16 million adolescents aged 15 to 19 giving birth each year, accounting for 11% of all global births. This phenomenon significantly impacts maternal and child health, as well as the social and economic well-being of young mothers and their families. In Mexico, adolescent pregnancy rates remain among the highest globally, with more than 90% of new sexually transmitted infections (STIs) occurring in young women, and significant disparities in fertility rates between rural (2.8) and urban (2.01) areas.

Several studies have identified key risk factors associated with adolescent pregnancy, including lack of knowledge about contraception, low risk perception, peer pressure, low self-esteem, and limited communication about sexuality. Additionally, many traditional interventions have been limited in scope and effectiveness, as they fail to integrate motivational approaches or technological tools that align with adolescent communication preferences.

To address these challenges, the "Be Yourself" educational intervention was designed based on Self-Determination Theory and behavioral change models, aiming to foster self-determined motivation for adolescent pregnancy prevention. The intervention incorporates innovative strategies, including an artificial intelligence-powered chatbot and a web-based platform, allowing for dynamic, interactive, and accessible learning experiences for adolescents.

General Objective:

To evaluate the preliminary efficacy of the "Be Yourself" intervention in increasing self-determined motivation and promoting preventive behaviors against adolescent pregnancy among secondary school students.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

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

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.

干预措施: Conventional Sex Education (Other)

结局指标

主要结局

Increased rates of Self-Determined Motivation to prevent teenage pregnancy

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

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.

Increase in the Level of Knowledge about Pregnancy Prevention

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

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.

Improving Communication on Sexual Issues

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

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.

Change in Life Goals

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

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.

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

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

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.

次要结局

  • 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.)
  • 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.)

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natanael Librado Gonzalez

Master of Science in Nursing

Universidad Autonoma de Nuevo Leon

研究点 (1)

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