Clinical Research Directory

GAGE Act With Her-Ethiopia Evaluation

This study evaluates the impact of Act With Her Ethiopia (AWH-E), a gender transformative multi-level program that aims to improve the lives of young adolescent boys and girls.

Laughter Yoga Integrated PRECEDE-PROCEED Health Education Program in Adolescents

Adolescence is a critical developmental period in which lifelong health behaviors are shaped, and behaviors acquired during this stage significantly influence health outcomes in adulthood. Physical activity, healthy nutrition, adequate sleep, stress management, and positive social relationships are among the key determinants of adolescent health. However, current evidence indicates that physical inactivity, unhealthy dietary habits, sedentary lifestyles, and psychosocial problems remain highly prevalent among adolescents globally. In addition, insufficient access to health information and inadequate health information-seeking behaviors among adolescents have been reported to be associated with risky health behaviors. Therefore, the development of healthy lifestyle behaviors in adolescents is considered a public health priority. Schools are recognized as strategic settings for health-promoting interventions targeting adolescents due to their significant social and educational influence on health behaviors. Recent systematic reviews and meta-analyses report that school-based and multi-component interventions have positive effects on adolescents' health behaviors and psychosocial well-being. The integration of behavioral and psychosocial components in school-based health education programs has been associated with more effective and sustainable improvements in adolescent health outcomes . In this process, school health nurses play a critical role in planning and implementing preventive and health-promoting interventions for adolescents . Moreover, it has been reported that healthy behaviors gained through school health nursing interventions may persist into adulthood . Additionally, a systematic review of health education interventions has shown that multi-component approaches-such as classroom education combined with school policies, parental involvement, and school-community collaboration-produce more significant effects on adolescent health outcomes. In recent years, there has been increasing interest in complementary approaches supporting stress management and emotional well-being in school-based interventions. In this context, laughter yoga is described as a low-cost, feasible, and group-based method associated with reduced stress, improved psychological well-being, and enhanced social interaction. Experimental studies conducted with adolescents have also demonstrated that laughter yoga has positive effects on school burnout, hope, and educational stress. However, the literature indicates a limited number of studies examining the integration of laughter yoga into structured school-based health education programs and its effects on healthy lifestyle behaviors. In line with the life-course health perspective, school-based interventions aimed at health promotion during childhood and adolescence are reported to be critical for the sustainability of healthy lifestyle behaviors. In this context, the PRECEDE-PROCEED Model is a theoretical framework widely used in the planning and implementation of health promotion programs, systematically assessing behavioral, environmental, and psychosocial factors influencing health behaviors. Studies based on the PRECEDE-PROCEED Model have demonstrated its effectiveness in improving health behaviors among adolescents. Furthermore, current evidence emphasizes that parental involvement in school-based health interventions strengthens the sustainability of behavior change, highlighting the need for further research in this area. The literature indicates that no studies have examined the effects of a health education program based on the PRECEDE-PROCEED Model integrated with laughter yoga on adolescents' healthy lifestyle behaviors. This gap highlights an important research need for interventions that combine a theoretical behavior change framework with complementary practices that may enhance psychosocial well-being. Study aim Accordingly, the aim of this study is to evaluate the effect of a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga on healthy lifestyle behaviors of secondary school students. Study hypotheses H1: Students who receive a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga will have significantly higher healthy lifestyle behavior scores compared to the control group.

Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth

This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.

Using Mentalization Based Therapy to Support Children and Adolescents Referred to Specialist Mental Health Services in the NHS for Aggressive and/or Violent Behaviour

The MICA Study is a research project that has been designed to work out how helpful mentalisation based therapy is. This is a new type of support that helps young people make sense of their own behaviours and feelings, and those of others. It involves meeting regularly with a mental health practitioner and parents/carers can be involved in some meetings too. It is hoped that this new type of support will help young people stop acting aggressively/violently. This project will be delivered in Forensic Child and Adolescent Mental Health Services (FCAMHS) in England. This service supports some of the most vulnerable young people in the country, who may also have involvement from other professionals including the Youth Justice System. The aim of the research is to make the support better for young people who use these services. This research involves doing a randomised controlled trial. This means half the young people will get the usual support from FCAMHS, and half will get the usual support plus the new support. The results will be used to compare mentalisation based therapy to the support FCAMHS usually provides. This will show the best way to support young people with their aggressive/violent behaviours. To start with, young people will answer a questionnaire. Following this, young people will receive either usual support or usual support plus MBT for six months. After this, young people will answer a questionnaire again. Some young people will be asked to take part in an optional interview to share their thoughts on this research. All young people aged 10-17 years who have been referred to a FCAMHS in England will be asked to take part, as long as they can speak and understand English. Some young people might not want to take part in this research and that will not change the support they receive.

Navigating Mental Health Treatment for Black Youth

This study looks to conduct a systematic adaptation of Suicidal Teens Accessing Treatment (STAT-ED) for Black youth presenting in the emergency department who have suicide risk. A randomized controlled trial of STAT-ED adapted for Black youth and their caregivers will examine whether patient navigation intervention can increase mental health treatment initiation and number of visits.

Evaluation of a Family-centered Program for Problematic Gaming/Excessive Screen Use

The Family-Centered Program for Problematic Gaming and Excessive Screen Use (FAME) is a pioneering initiative designed to address the growing challenges of excessive screen use and gaming among children and adolescents, particularly within family dynamics.

Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence

The goal of this research study is to implement and evaluate a comprehensive community-level approach, Healthy Communities for Youth, that includes both a selective hospital-based prevention strategy, Emerging Leaders, and universal prevention strategies that increase Positive Youth Development opportunities through participatory action research, stakeholder education, community mobilization, and an overall focus on increasing community capacity for prevention. Key project aims are to evaluate the impact of Healthy Communities for Youth on community rates of youth violence using surveillance data and evaluate the impact of each violence prevention strategy on proximal outcomes including their impact on risk factors and protective processes related to multiple forms of youth violence.

Fostering Healthy Futures for Teens: An RCT

This study will implement and evaluate a mentoring program designed to promote positive youth development and reduce adverse outcomes among maltreated adolescents with open child welfare cases. Teenagers who have been maltreated are at heightened risk for involvement in delinquency, substance use, and educational failure as a result of disrupted attachments with caregivers and exposure to violence within their homes and communities. Although youth mentoring is a widely used prevention approach nationally, it has not been rigorously studied for its effects in preventing these adverse outcomes among maltreated youth involved in the child welfare system. This randomized controlled trial will permit us to implement and evaluate the Fostering Healthy Futures for Teens (FHF-T) program, which will use mentoring and skills training within an innovative positive youth development (PYD) framework to promote adaptive functioning and prevent adverse outcomes. Graduate student mentors will deliver 9 months of prevention programming in teenagers' homes and communities. Mentors will focus on helping youth set and reach goals that will improve their functioning in five targeted "REACH" domains: Relationships, Education, Activities, Career, and Health. In reaching those goals, mentors will help youth build social-emotional skills associated with preventing adverse outcomes (e.g., emotion regulation, communication, problem solving). The randomized controlled trial will enroll 234 racially and ethnically diverse 8th and 9th grade youth (117 intervention, 117 control), who will provide data at baseline prior to randomization, immediately post-program and 15 months post program follow-up. The aims of the study include testing the efficacy of FHF-T for high-risk 8th and 9th graders in preventing adverse outcomes and examining whether better functioning in positive youth development domains mediates intervention effects. It is hypothesized that youth randomly assigned to the FHF-T prevention condition, relative to youth assigned to the control condition, will evidence better functioning on indices of positive youth development in the REACH domains leading to better long-term outcomes, including adaptive functioning, high school graduation, career attainment/employment, healthy relationships, and quality of life.

Personalized Approach To Habits - Sleep

Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep

Using Shared Decision Making to Improve Family Media Use Planning

Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Family Media Check-In (FMC).

The Canadian Underage Substance Use Prevention Trial

Despite having made some strides with respect to reducing adolescent drinking rates, illicit substance use and substance use disorders (SUDs) remain significantly above national targets for health promotion and disease prevention in Canada and the United States. Now, more than ever, there is a pressing need for effective substance abuse prevention in Canada, particularly for those most at risk of developing substance use problems including prescription drug misuse. Clearly, new approaches to prevention (with lower numbers needed to treat) are needed and which translate new research on addiction vulnerability to personalised prevention and early intervention. The PreVenture Program involves brief cognitive-behavioural interventions targeting personality traits from a neurocognitive perspective. While the personality-targeted approach has been shown to be effective in reducing most substance use behaviors, it has yet to be evaluated for its impact on uptake of prescription drug misuse in adolescents. The Canadian Underage Substance use Prevention (CUSP) Trial aims to evaluate the long-term effects of a personality-targeted school-based prevention program on delaying the onset of drug and alcohol use in adolescence over three years across Canada. This is a hybrid effectiveness \[E\] and implementation-facilitation \[IF\] trial on delaying the onset of drug and alcohol use in adolescence. In the \[E\] part, the effects of a personalized prevention program will be tested against usual school-based prevention curricula. PreVenture is delivered through a TtT implementation model with or without \[IF\], e.g. with ongoing supervision and web-based support. The \[IF\] package is designed to support long-term sustainability of PreVenture after a community accesses PreVenture training.

HIV Engagement and Adolescent Depression Support (HEADS-UP)

This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.

Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care

The purpose of the study is to rigorously evaluate Next4You, an innovative, fully mobile program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in the foster care system in California.

Internet-based Talking About Risk and Adolescent Choices: Health and Emotion Regulation Options

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Rigorous Evaluation of Let's Talk Birth Control

The goal of this cluster-level randomized controlled trial is to evaluate the impacts of Let's Talk Birth Control, a clinical decision support intervention for adolescents that consists of a printed contraceptive decision aid (CDA), contraceptive counseling, and a QR code to the Bedsider.org Method Explorer (ME). The goal of Let's Talk Birth Control is to reduce rates of sex without a contraceptive method among adolescent patients, increase use of preferred contraceptive method, as well as to increase self-efficacy to discuss, obtain, and correctly use contraceptive methods The primary research questions are: * Does receiving care from a health center participating in Let's Talk Birth Control reduce rates of sex without a contraceptive method among adolescent patients compared to those visiting a standard of care control health center? * Does receiving care from a health center participating in Let's Talk Birth Control increase use of preferred contraceptive method among adolescent patients compared to those visiting a standard of care control health center? The evaluation will focus on the impacts of receiving the Let's Talk Birth Control intervention, as compared to receiving standard health care services. As part of this study: * All participants will be asked to complete baseline, 1-week post-intervention, and 9-month follow-up surveys. * Participants at health centers randomized to receive the Let's Talk intervention, will be asked to: * Review the Let's Talk CDA independently prior to meeting with their healthcare provider * Participate in an observation focused on the provider's use of the CDA for contraceptive counseling during the healthcare visit (select participants only) * Participate in a focus group discussing their perceptions of the Let's Talk Birth Control intervention (select participants only) Staff at health centers randomized to receive the Let's Talk intervention will be asked to: * Complete a 45-60 minute online asynchronous training covering patient-centered contraceptive counseling (PCCC) for adolescents and using the CDA * Use the Let's Talk CDA to facilitate patient-centered contraceptive counseling with patients that have enrolled in the study

Tennessee Youth Prepared for Success

The principal objective of Tennessee Youth Prepared for Success is to pilot, implement, and test innovative adolescent pregnancy prevention strategies using a randomized controlled trial (RCT) to effectively educate youth on both abstinence and contraception with the goal of reducing youth pregnancies, births, and STIs. Tennessee Youth Prepared for Success will address Adulthood Preparation Subjects (APS) to promote youths' successful and healthy transition to adulthood; include a Positive Youth Development (PYD) approach to engage youth and provide positive influences and skill building opportunities; and implement activities/interventions within a trauma-informed approach to account for the mental health needs of those who have experienced maltreatment, abuse, or violence. The project's goals and principal and subordinate objectives align with the PREIS program's goals/objectives and purpose, including (1) targeting high-risk youth to prevent pregnancy and STIs, including HIV/AIDS; (2) rigorously evaluating interventions using an RCT; (3) manualizing/packaging curriculum; and (4) disseminating lessons learned, best practices, and relevant findings. Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural counties in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth (e.g., systems-involved).

Psychiatric Care and Education for Adolescents and Young Adults in the Ile-de-France Region: Expectations and Experiences of Young People and Parents Concerned

Most chronic psychiatric disorders begin before the age of 18. In the most severe cases, prolonged hospitalization is essential, but this ultimately leads to harmful school dropout and social exclusion. "Care-study" hospitalizations offer comprehensive psychiatric, educational, and social care to prevent this. However, these programs have been largely under-evaluated ; only one limited and very old study has looked at the perspective of the young people concerned, and none at all has looked at their parents. Today, however, PREMS (Patient-Reported Experience Measures), which assess how users experience care (satisfaction, subjective and objective experiences, relationships with caregivers), are important indicators for improving care systems. the investigators therefore wish to gather young people's expectations regarding healthcare and education, as well as their opinions and those of their parents on their experiences in the current context, in order to evaluate and improve these systems by better meeting the expectations and needs of users.

Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer

The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.

Cannabis, Linked Emotions, and Adolescent Risk Study

The goal of this study is to disentangle relationships between acute cannabis use and withdrawal on proximal depression and suicide risk and recovery in adolescents ages 12-18 years by incorporating time-varying patterns of substance use, mood, and SI. This project aims to guide the development of scalable, individualized, accessible, and affordable interventions aimed to reduce depression and suicide risk among adolescents.

Cognitive Remediation Intervention to Prepare for Transition of Care

Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.

Adolescents and Young Adults With Cancer: Their Preferred Involvement in Decision Making

The purpose of this mixed-methods study is to determine Adolescent and Young Adult (AYAs) decision making preferences post cancer diagnosis using vignettes designed to assess their preferred involvement in decisions about their cancer treatment and variables associated with these treatment decision-making (TDM) preferences.

Benefits of Physical Activity During the School Day to Reduce Mental Fatigue and Optimize Cognitive and Psychosocial Processes in Secondary School Students

The main aim of the MENTALFIT project is to test the effectiveness of physically active teaching methodologies to reduce mental fatigue and optimize cognitive, emotional, and motivational processes in secondary school students. Specifically, the study aims to examine differences depending on the type of physically active strategy implemented (physically active learning, active breaks, and active recesses) on students' mental fatigue, cognitive function, group dynamics, and motivational processes. Furthermore, the project aims to compare whether learning and academic performance are similar in traditional classes versus classes employing a physically active teaching methodology. Finally, a secondary objective of the project is to create and validate new instruments to assess the different psychobiological and educational processes included in this project.

Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. The study employs a longitudinal case-controlled design in 60 14-18 year old youth with ASD at 3 time-points 8 months apart, each including m-fMRI during learning and behavioral measurement of executive and adaptive function. Aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. Aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. Aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.

Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement

The purpose of this research study is to learn if a parenting program called Adolescent Mental Health Parenting Program for Child Adult Relationship Enhancement (AMP-CARE) can help parents have more confidence in parenting their teen and improve their knowledge about normal teen development and teen mental health. The main questions it aims to answer are: * Does the AMP-CARE parenting program improve confidence in teen parenting and positive parenting? * Does the AMP-CARE parenting program improve parent knowledge about mental health? Researchers will compare participants who complete the parenting program to those who do not. Participants will: * Complete 2 surveys, one at the start of the study and one 6 -12 weeks later * Half of the participants will be randomly picked to attend the 6 virtual AMP-CARE sessions right away. * The other half will have the opportunity to attend AMP-CARE after they complete the second survey.