Clinical Research Directory

Reproductive Axis Maturation in the Early Post-Menarchal Years

Background: Most adult women with irregular periods of unknown cause report symptoms dating back to early adolescence. This study aims to learn how girls' periods change in the 2 years after their first period. We are also looking at girls who may have a condition called PCOS. This will help researchers learn what healthy puberty looks like and how they can spot signs of hormone problems early on. Objective: To learn how long it takes girls to develop regular menstrual cycles after their first period. Eligibility: Healthy girls ages 8-14 who either (1) haven't had their first period but show signs of puberty, such as breast development and hair in the genital area; or (2) had their first period in the past 6 months Girls at risk for PCOS age 8-14 who have a mom or sister with PCOS Girls with irregular menstrual cycles age 11-17.5 To compare with the girls, we are looking at women \>=18-34 years old with PCOS, Healthy women \>= 18-34 years old without PCOS, and Mothers of pediatric participants age 18-65 Design: Both parents or guardians must allow their daughter to participate. They must attend all study visits with her. Participants will first be screened by phone. Those who qualify will be screened in person. They will have a physical exam. They will give blood and urine samples. They will have an ultrasound of their abdomen. They will fill out questionnaires. They will sit in a BOD POD for 6 minutes: This is an egg- shaped machine that takes body measurements. They have the option to provide DNA samples. Participants will have sets of visits at home or at the clinic about every 6 months. The number of visits in each set will depend on their menstrual cycle. Then they will have a final visit. Visits will include repeats of the screening tests. There are additional parts that participants may choose to be involved in depending on how involved they want to be. At home, participants will collect their urine daily to measure hormones. They will keep a diary of their periods. Adults: Women with known PCOS will complete the same Screening Visit as the girls and will collect dried urine specimens at home for 8 weeks; The Healthy control women group will complete the same Screening Visit as the girls and collect dried urine specimens at home for 2 menstrual cycles; The Mothers of pediatric participants group will complete a Screening Visit (informed consent, urine pregnancy test) and collect vaginal swab specimens at home for 2 menstrual cycles (approx. 8 weeks)....

Meet Me on the Pitch: Developing and Testing a Community-Based Sports and Behavioral Health Intervention for Youth

This study evaluates Meet Me on the Pitch (MMotP), a community-based intervention that integrates sports, schools, and behavioral health with the goal of improving the behavioral health, well-being and academic performance of youth. MMotP is a novel approach that builds on evidence-based practices by using sports as a means to foster social-emotional development and address barriers to academic, health, and social services. The study assesses feasibility, acceptability, and short-term outcomes through a randomized controlled trial comparing MMotP to standard sports programming. The intervention will be implemented by the non-profit organization Soccer Without Borders and evaluated by the University of California, San Francisco.

My Life - I Decide: A Health Promoting School Intervention

Background The proportion of young people experiencing poor mental health and well-being is increasing, placing this group at high risk of not completing secondary education. Educational attainment and health status are strongly correlated, underscoring the need for interventions to address this development. Approximately half of Danish 10th grade students report feeling tired of school, while one in four report pressure and low academic confidence. Schools represent a unique setting for health promotion by enhancing social and emotional competencies, emphasizing the necessity of positioning the school as a health-promoting environment for 10th grade students. In one Danish local community, a teaching component focused on life-skills for 10th grade students has been developed and tested over several years. Positive outcomes have been reported, although the experiences also revealed a need for organizational and structural changes to support implementation and enhance impact. Research supports such approaches, recommending whole-school interventions that emphasize health-promoting structures both within the school and in the broader community. The My Life Initiative My Life - I Decide is a health-promoting school intervention targeted at 10th grade students in Denmark. The purpose of the My Life research project is to develop and evaluate the processes, effects, and scalability of a health-promoting school intervention aimed at improving physical and positive mental health and school well-being among 10th grade students. The intervention is based on a health-promoting school approach and incorporates teaching inspired by outdoor-based learning, the life psychological method, action learning, and continuous evaluation and implementation of health-promoting actions at class, school, and community levels. The health and well-being curriculum consists of 28 lessons delivered over 8-10 weeks. The program focuses on ten life-skills designed to strengthen self.efficacy, social, emotional, and health-related competencies and school well-being. Lessons are delivered by a local community health consultant in close collaboration with one or more 10th grade teachers. This organizational structure has been well-received, as it injects new energy into teaching, strengthens cooperation between schools and local communities, and builds teacher capacity. Implementation of health-promoting actions at the school and community levels is facilitated through an evidence-based, system-oriented co-creation process. This process involves representatives from schools (teachers, students, and leadership), local community health consultants and coordinators, and civil society actors. The aim is to create health-promoting environments that support students' physical and positive mental health and school well-being through structural and organizational changes. Collaboration and Research Design Collaborators include Steno Diabetes Center Copenhagen, the Intersectoral Prevention Laboratory, and ten local communities in the West and South regions. This formalized practice and research collaboration aims to further develop the initiative in a pilot study, followed by an evaluation of its effectiveness using a controlled waitlist design. The project will generate knowledge on how, and under which circumstances, the initiative produces the desired effects, and whether national implementation is feasible. The intervention project runs for 1.5 years, with research examining impact through a controlled waitlist design involving approximately 26 classes and 500 students. Intervention classes will implement the initiative in 2025/2026, while waitlist classes will implement it in 2026/2027. Impact will be tracked through electronic student questionnaires administered at three time points: baseline (start of the school year), mid-point (before Christmas), and follow-up (before summer break). A process evaluation will assess implementation, contextual adaptation, and mechanisms of change using interviews, focus groups, observations, and surveys. Data will be analyzed and reported in scientific articles, with findings addressing the overall research objectives and refining a logic model for the initiative to support implementation in other schools.

Evaluating the Effectiveness of Print Based Environmental Health Intervention Education Among School Going Adolescents of Karachi, A Quasi Study

This study investigates the impact of school-based educational interventions on adolescents' knowledge and practices related to environmental health in Karachi, Pakistan. The methodology opted for this research is quasi experiment with three months intervention period. The research will begin with a baseline survey to assess adolescents' understanding of environmental health, green spaces, waste management, and associated health impacts. Schools are then engaged in creating and maintaining green spaces and adopting waste management practices. Two intervention arms are implemented: Arm 1 receives educational content through posters, while Arm 2 receives pamphlets. In March, schools are revisited to evaluate the maintenance of cleanliness and green spaces. Finally, in April, a post-intervention survey will be conducted to measure changes in knowledge and eco-friendly practices. The study aims to determine the effectiveness of posters versus pamphlets in enhancing knowledge and sustaining environmental practices among adolescents, thereby contributing to evidence-based strategies for promoting environmental health education in urban school settings.

Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents (IYG)

The investigators are writing to inform participants about a study being carried out by a research group from the University of Granada and the University of Seville, in which the participant's son/daughter is invited to participate. The study has been approved by the Provincial Research Ethics Committee of Granada under code 202499906944441. The sole intention of the investigators is to ensure that participants receive correct and sufficient information to assess and decide whether or not to give consent for the child's participation in this study. The information sheet should be read carefully, and any questions may be addressed to the investigators. The objective of the study is to culturally adapt the program It's Your Game: Keep it Real (IYG), which aims to prevent risky sexual and affective behaviors in adolescents. The IYG program consists of 12 lessons, each lasting 45 minutes. These lessons aim to help the child identify personal norms and boundaries regarding sexuality, recognize situations that might challenge these boundaries, and develop refusal skills to maintain them. The program also covers topics such as the characteristics of healthy and unhealthy relationships, friendships, anatomy and reproduction, the social, emotional, and physical consequences of sexual activity, the consequences of teenage pregnancy and STIs, condom and contraceptive use, and communication skills. This adaptation will involve the child completing all 12 lessons (two lessons per week over a period of six weeks) that make up the IYG program, as well as filling out a series of questionnaires. These questionnaires will allow the investigators to assess the usability of the program in Spain (including ease of use, comprehension, acceptability, as well as aspects most liked and suggestions for improvement). Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way. In all cases, the CONFIDENTIALITY of the data collected will be maintained in accordance with the European Union General Data Protection Regulation (GDPR) 2016/679 and the Spanish Organic Law on the Protection of Personal Data and Guarantee of Digital Rights (LOPD-GDD) 3/2018, of December 5. Regarding the study results, these may be shared with the scientific community through presentations, conferences, and/or publications. The investigators express appreciation in advance for cooperation in this study.

Decision Support Intervention of Minor Cancer Patients and Their Parents

The purpose of this stuidy are: (1) to explore the information needs of parents having children with cancer when making treatment decisions; (2) to develop a Taiwan version of the Control Preferences Scale for decision support aids; (3) to implement and evaluate the effectiveness of involving minor cancer patients and their parents in treatment decision-making.

Youth-for-Youth Mental Wellness Care and Action

This initiative aims to improve flourishing and quality of life of secondary school students, reduce mental distress (e.g., depression and suicidal ideation), enhance their understanding of mental health (e.g., mental health literacy) and help-seeking intention, and foster a supportive school environment (e.g., school climate-caring relationship, and sense of community). Also, this initiative aims to improve students' process of change in psychological (e.g., mattering, emotion regulation, empowerment) and social (e.g., trust belief) aspects and mental health awareness (e.g., mental health stigma). The feasibility, acceptability, and sustainability of the programme from multiple perspectives (e.g., students, student leaders, and stakeholders) will also be evaluated. In addition, the cost-effectiveness of delivering this programme (e.g., the incremental cost-effectiveness ratio (ICER)) among secondary schools in Hong Kong will be assessed. The programme will be implemented among students in 130 local secondary schools over three academic years. The first is a pilot phase (Year 1), which 40 schools will implement the intervention and student participants will be evaluated at pre- (T0) and post-intervention (T1) using questionnaires. In this stage, participatory research will be conducted before and after the intervention among students, student leaders, and stakeholders in 20 pilot schools to co-design the intervention, ensuring the programme meet the actual wellness needs of youth. In following two academic years, an additional 90 schools will participate in a cluster randomized controlled trial (RCT) with a 1:1 ratio between intervention and waitlist control groups. Each year, 45 schools will implement the intervention. Summative evaluation will be conducted among RCT schools at T0 and T1, and 3-month follow-up (T2). Quantitative data be collected to assess the effectiveness of intervention, and qualitative data will provide understanding of students' and stakeholders' perspectives of the intervention implementation. Cost outcomes will include intervention costs and cost savings, calculated from the payer (i.e., JC/government) perspective using administrative records or validated tools. The primary outcome of effectiveness will be the quality-adjusted life-years (QALYs) of students. Cost and QALYs will be used to evaluate the cost-effectiveness of the intervention, for example, estimate the incremental cost-effectiveness ratio (ICER).

Screening and Support for Youth (SASY)

To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area

Empowering Knowledge, Self-Testing & Resilience Through Innovative Methods for HIV

The goal of this study is to learn whether a digital tool can help improve HIV knowledge, self-awareness, and testing among adolescents in Yogyakarta, Indonesia. The tool includes online HIV education, a self-assessment for HIV risk, and access to trained peer educators for support. The study will also explore how comfortable and willing adolescents are to use this kind of digital health service. The main questions the study aims to answer are: * Can this digital tool help adolescents better understand HIV and their personal risk? * Will more adolescents be willing to get tested for HIV after using the tool? * What factors affect whether adolescents accept and use digital HIV services? Researchers will compare two groups of high school students: * One group will use the digital tool for 6 weeks * The other group will receive standard HIV education (not through the tool) Participants will: * Answer surveys before and after the 6-week period * Learn about HIV through videos and interactive content * Use the tool to assess their personal HIV risk * Receive support from trained peer educators (online) The researchers hope this study will lead to new ways of using technology to improve HIV prevention and testing for young people.

Health Without Barriers/Salud Sin Barreras- Northern Colorado

The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.

Nursing Strategies to Increase Vaccination Rates in Adolescents: Education, Video Animation and Games

Purpose: This study aims to evaluate how immunization education, video animation, and game interventions based on the Health Belief Model (HBM) affect the immunization decisions of late adolescents. The findings could contribute to the development of targeted interventions to increase vaccine acceptance among adolescents. Hypotheses: Does the educational intervention, video animation, and game application affect adolescents' knowledge of vaccines? Do these interventions influence adolescents' positive attitudes towards vaccines? Will the interventions lead to significant changes in adolescents' health beliefs, especially regarding perceived risks, benefits, and barriers? Do the interventions increase vaccine acceptance and vaccination rates among adolescents? Do the interventions reduce vaccine hesitancy among adolescents? Can the Health Belief Model-based interventions provide an effective communication strategy to increase vaccine acceptance? Method: The research will be conducted from March 3 to March 30, 2025. Participants will undergo immunization education, video animation, and game applications. Expert opinions will be consulted for developing educational materials, videos, and games. Institutional approval will be obtained, and an informed consent form will be distributed to participants. Those who volunteer will be assigned numbers, and participants for the intervention and control groups will be selected using simple random sampling. Interventions: Educational Material: Aimed at increasing awareness about vaccines, the education focuses on the perceived risks, benefits, and barriers to vaccination. Video Animation: A video that explains how vaccines work, strengthen the immune system, and address perceived risks and benefits. Game Application: A simulation game called "infected interaction," where participants learn about the spread of infectious diseases during social interactions. Inclusion Criteria: Inclusion: Adolescents aged 18-21, willing to participate, complete research forms, and attend the sessions. Exclusion: Withdrawal from the study. Variables: Independent Variables: Gender, age, income, school, chronic illness, etc. Dependent Variables: Scale scores. Data Collection Tools: Adolescent Introductory Questionnaire: A form with 14 questions about demographic information and attitudes toward vaccination. Vaccine Hesitancy Scale: A 9-item scale measuring vaccine hesitancy. Self-Efficacy Scale: A 23-item scale to assess adolescents' self-efficacy in various contexts. Statistical Analysis: Sample size was determined by power analysis: 210 participants (105 intervention, 105 control). Data will be analyzed using IBM SPSS Statistics V 26. Normal distribution will be assessed with the Shapiro-Wilk test, and homogeneity of variance will be tested with Levene's test. Pre- and post-test scores will be compared using repeated measures ANOVA. A p-value of \<0.05 will be considered statistically significant. Expected Outcomes: Increased Knowledge: It is expected that educational interventions and video animations will improve adolescents' knowledge about vaccines, potentially influencing their attitudes. Positive Attitude Change: The intervention may lead to more positive attitudes towards vaccination. Changes in Health Beliefs: The intervention could alter adolescents' perceived risks, benefits, and personal beliefs regarding vaccines. Increased Vaccine Acceptance: The study may demonstrate that these interventions increase vaccine acceptance and vaccination rates. Effective Communication Strategies: The study may identify effective communication strategies for increasing vaccine acceptance among adolescents. Contribution to Public Health: This research could show that interventions targeting adolescents may play a critical role in improving public health by reducing the spread of infectious diseases.

Knowledge of Adolescent Well-care Visits and Attitudes Amongst Physicians

The goal of this observational study is to be a quality improvement project to assess the knowledge, attitude towards adolescent well visit screening and preventing counseling amongst pediatrician and family medicine physicians in Al-Ain city. We will be conducting an online survey covering general aspects regarding adolescent well-being visits, before and after providing necessary education to the participants

HPV Vaccine Integrated Service Implementation Research in Cameroon

The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls and boys in the North and Far North Regions of Cameroon. The main questions this study aims to answer are: * Can a package of community-based interventions increase delivery of routine HPV vaccination to boys and girls aged 9-13 in Cameroon's North and Far North Regions? * What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to deliver routine HPV vaccination in Cameroon? To evaluate the effectiveness of the intervention, researchers will compare HPV vaccination within regions where the new intervention model is being implemented (intervention areas) to regions where the new routine HPV vaccination delivery model is not being implemented (comparison areas) for approximately 1 year before the new intervention model is implemented and for approximately 9 months after the start of implementation to compare changes over time and between intervention and comparison areas. The study will evaluate the effect of the intervention on HPV vaccination delivery using routine health facility data. To understand acceptability, feasibility, implementation, and potential for scale, the study will enroll participants including health officials and providers, adolescents girls receiving HPV vaccination and other services in intervention areas, and their parents/caregivers. The study will be conducted in two phases, with the first phase focused on gathering formative data through interviews with key informants. This data will be used to inform the design of the intervention, which will be implemented and evaluated in phase 2. Only phase 1 of this study protocol has been currently approved. In phase 1, key informant interview participants will be asked to participate in a an interview to discuss HPV vaccination services and their perspectives on how to integrate HPV vaccination within existing community-based and health facility structures and programs. Key informants will include government officials, health program implementers, representatives from non-government organizations working on HPV vaccine delivery, and healthcare providers, as well as community leaders including school and religious leaders.

HPV Vaccine Integrated Service Implementation Research in Ethiopia

The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls in rural Ethiopia. The main questions this study aims to answer are: * Can a package of community-based interventions increase delivery of routine HPV vaccination to girls aged 9-14 in rural Ethiopia? * Is an intervention model that incorporates strategies that address gender norms and gender-specific barriers more effective at increasing delivery of routine HPV vaccination than a model that does not explicitly address gender? * What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to delivery routine HPV vaccination in rural Ethiopia? To evaluate the effectiveness of the intervention, researchers will compare HPV vaccination within regions where the new intervention model is being implemented (intervention areas) to regions where the new routine HPV vaccination delivery model is not being implemented (comparison areas) for approximately 1 year before the new intervention model is implemented and for approximately 1 year after the start of implementation to compare changes over time and between intervention and comparison areas. The study will evaluate the effect of the intervention on HPV vaccination delivery using routine health facility data. To understand acceptability, feasibility, implementation, and potential for scale, the study will enroll participants including health officials and providers, adolescents girls receiving HPV vaccination and other services in intervention areas, and their parents/caregivers. These participants may be asked to participate in one or more of the following: * Completing a short questionnaire after receiving health services, including HPV vaccination, and their knowledge and attitudes towards HPV vaccination and experiences of care * Participating in an interview or a focus group discussion to discuss HPV vaccination services and the role of the intervention in delivering care