553 Clinical Trials for Various Conditions
This is a quasi-experimental longitudinal study to compare the outcomes of youth in Psychiatric Residential Treatment Facility (PRTF) compared to youth in the at-home Child-Focused Assertive Community Treatment Team \[Child ACTT\] program. The hypothesis is that Child ACTT will be associated with better outcomes and lower cost than PRTF among adolescents admitted to Child ACTT or PRTF.
There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use. The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up.
This study evaluates the efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Connecting is a 10-week, self-directed parenting workbook with two digital video discs (DVDs). Families receive weekly telephone support as they complete the program.
The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.
Investigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.
The goal of the project is to find out how the investigators can use mobile phones to prevent HIV and address related health problems such as sexual health and mental health among adolescents. The investigators will evaluate and adapt an existing text-message and interactive voice recognition (IVR) system. IVR is Interactive voice response is a technology that allows humans to interact with a computer-operated phone system through the use of voice and DTMF tones input via a keypad. The system was designed by FHI 360 (note FHI 360 is the name of the non-profit not an acronym). FHI 360 is an international nonprofit working to improve the health and well-being of people in the United States and around the world. FHI 360 staffs more than 4,000 professionals who work in more than 60 countries. Examples of the existing content is available (https://m4rh.fhi360.org/?page_id=191) and we have a letter of support from FHI 360, included in my funded grant proposal, stating we may use and modify this content as needed. As noted below anyone can access this content by dialing #161 when in Uganda. FHI 360 sexual reproductive health information is currently available across Uganda for free and can be accessed in by dialing #161. The proposed research comprises two phases. Phase 1 involves two steps, (A) "theater pretesting" (includes brief interviews) (B) focus groups (or more detailed interviews depending on COVID-19 guidelines and described in detail below) that will involve asking adolescents to discuss new messages that would provide basic information about pre-exposure prophylaxis (PrEP) as well as, a set of questions about mental health, and alcohol use. We will conduct focus groups with these adolescents and elicit responses to improve the acceptability of the messages (described in detail below). We will then modify any content as needed and conduct Phase 2 which involves (A) randomized control trial and (B) qualitative key informant interviews. Adolescents (N=200) will be randomly assigned to either the mobile phone-based intervention or to standard of care. Through this approach we will evaluate our adaptation of FHI 360's existing text message and interactive voice recognition (IVR). The adaptation will include PrEP information as well as specific mental health and hazardous alcohol use screens, promote HIV prevention for all adolescents, and support linkage to behavioral health counselors for symptomatic adolescents.
We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.
The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.
As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health. The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.
This study evaluates the effects of mindfulness on physiological stress mechanisms implicated in externalizing behaviors and symptoms of affective and traumatic stress among urban adolescents. Program effects on stress physiology will be evaluated using pre- and post-tests of heart rate variability (HRV) during a stress task. Emotional and behavioral outcomes will be measured using student and teacher ratings.
The purpose of this study is test the American Academy of Pediatrics (AAP) Family Media Use plan among teens and their parents through a randomized intervention and assess impact on outcomes including family media rules and health behavior outcomes.
The goal of this study is to test whether the mobile application (app.) helps adolescents make healthy food choices, decreasing calories purchased from restaurants, fewer number of visits to restaurants, and if it has an impact on their body mass index (BMI). Eligible adolescents will be enrolled in the study along with a parent for approximately 6 weeks.
The purpose of this study is to test if a parenting program can be used to prevent substance use among Latino youth and at the same time promote healthy eating. Pairs of 7th grade students and one of their parents will be enrolled in the study and randomly assigned to three groups: an existing parenting intervention focusing on substance use prevention (FPNG), the enhanced parenting intervention that also has nutrition content (FPNG+), and a comparison program focused on academic success. Only parents will attend intervention sessions. Data will be collected from the parent and their 7th grade student to see how these programs impacted substance use, nutrition, and parenting. The investigators hypothesize that families receiving the FPNG+ will have improved nutrition habits than the other conditions. Students in both FPNG and FPNG+ will have lower substance use rates as compared to the academic success program. In addition, the effects of parenting strategies and sociocultural factors on the FPNG and FPNG+ results will be studied.
Background: The Teen Health Information Literacy Project is an after-school program for high school students. It gives them skills to access valid and reliable health data. It also aims to grow young health advocates. Researchers want to find out more about the impact the program has had on students. They want to use this feedback to improve the program. Objective: To gain feedback about the Teen Health Information Literacy Project. Eligibility: Young people who participated in the Teen Health Information Literacy Project. The project was run by Area Health Education Centers (AHECs) and sponsored by the National Library of Medicine (NLM). Design: The study will be explained to students during a program session. They will take consent forms home to their parents. Participants will split into 6 focus groups. Each one will be conducted at an AHEC project site. The focus group will be a 90-minute discussion between participants and an evaluator from the NLM. The evaluator will be present either in person or by video conference. The evaluator will ask participants questions, which may include the following. What did they like and dislike about the program? Why did they decide to participate? What have they learned? Would they recommend this program to another student? How has the program affected their interest in health-related careers? The discussion will be audio-recorded. The evaluator will use an automated tool to convert recordings into text. After that, she will destroy the audio.
The primary objective is to conduct a pilot study to determine the efficacy of evidence-based interventions delivered in primary care clinic settings on parent-teen health communication.
Preventive care for adolescents is vitally important for maximizing their health and well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive needs of adolescents as demonstrated by poor health outcomes for this population. In this grant application, the investigators propose to expand an existing computer decision support system (CDSS) into the investigators adolescent primary care practices for the purpose of implementing a comprehensive, and developmentally appropriate, screening and physician decision support process. Prior work completed by the investigators research group has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines. The investigators seek to positively impact the effectiveness of preventative primary care visits by applying this previous success to the investigators adolescent practice. The investigators hypothesize that the implementation of developmentally appropriate universal screening practices, using tablet technology, and enhanced physician decision support regarding clinically relevant guidelines for all annual adolescent preventive care visits will result in better health outcomes, including higher rates of adherence to physician recommendations and improved patient functioning. The specific research aims of this proposal are: Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years and tailored evidence-based clinical decision support for physicians. Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of specific mental and physical health problems and treatment outcomes in an adolescent primary health care setting. Adolescent primary care issues of interest for this project include sexually transmitted infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The investigators expect this project to improve the health outcomes of adolescents, guide future efforts to implement universal screening and CDSS in a variety of primary care settings, and provide additional evidence to support broad-based electronic screening and computerized decision support for use in preventive care as a method for improving adolescent health.
The proposed study builds upon preliminary studies in self-selected populations to identify opportunities for early identification of World Trade Center-related health consequences in adolescents. If adverse health consequences are identified, proactive cardiometabolic and pulmonary screening of exposed children may be indicated, with targeted interventions intended to prevent development of chronic obstructive pulmonary disease, and adverse cardiometabolic outcomes in adulthood.
The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.
The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.
The purpose of this study is to test the effectiveness of a new clinical decision support tool, Placement Success Predictor (PSP), in a naturalistic setting. PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type at a behavioral health center using machine learning algorithms. The primary hypothesis is that clients in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success will have better outcomes than the clients who were not. The secondary hypothesis is that clients' level of improvement over time will be positively correlated with the number of days they are in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success.
The purpose of this randomized clinical trial is to test the efficacy of a new clinical decision support tool, Placement Success Predictor (PSP). PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type using machine learning algorithms. The primary hypothesis is that if clinical team members have access to PSP results for youth in the experimental group, these youth will have better outcomes at the 3-month follow-up compared to youth in the control group.
This project will serve adolescents from low-income and historically underserved communities through expansion of existing after-school programs. Adolescents from these communities tend to have slower academic progression and higher high school dropout rates. Extracurricular activities, including informal education through after-school programming, have been suggested to improve these rates and increase college enrollment by supporting traditional classroom-based education. The proposed project aims to educate high school-aged adolescents in food, agriculture, natural resources, and human (FANH) sciences through informal food literacy education. The project also includes a two-tiered cross-age teaching model, allowing for adolescents to be educated by college interns and to become educators for younger youth. Existing curricula, that encompass FANH sciences, will be utilized at each stage of the project. The purpose of the project is not only to educate adolescents in FANH sciences, but also to advance their motivation and efficacy for graduating high school, attending college, and majoring in FANH sciences. The project aims to accomplish these objectives through empowering adolescents to obtain knowledge, skills, and excitement for food literacy. As this model has not been utilized previously, this project will produce a best practices guide for implementing the existing curricula within a two-tiered cross-age teaching model. Additionally, the college internship and mentoring program created through this project will be continued at the initial sites and expanded to other communities. This will allow for a sustainable approach to educating adolescents in FANH sciences and providing mentorship that encourages future enrollment in college.
The study will utilize a stepped wedge cluster randomized design to examine the effectiveness of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent SBIRT change package. Primary care providers will be randomized as to when they receive training and begin delivery of FaCES with their 12 to 17 year old patients, which includes targeted feedback based on the patient's endorsed substance use level on the S2BI screening instrument.
The North Carolina Immunization Branch will evaluate the use of the CDC program to improve adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or AFIX). This evaluation is the first of its kind in the nation and may have a profound impact on prevention. AFIX has four major components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. This program will evaluate the effectiveness of AFIX visits on affecting provider practices to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's immunization rates and strategies for improving rates. The investigators will compare the changes, from baseline to 5 months, in immunization for practices receiving virtual visits (webinars), in-person visits, and no visits (control group). Thirty practices will be randomly assigned to each intervention type. The main outcomes of this study are practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data will be collected on practices with at least 200 adolescent patients (note: there is no patient-level data collected in this study).
NEXT is a seven-year longitudinal assessment of a representative sample of U.S. adolescent and young adults starting at grade 10. The goals of the NEXT longitudinal study include: to identify the trajectory of adolescent health status and health behaviors from mid-adolescence through the post high school years; to examine individual predictors of the onset of key adolescent risk behaviors and risk indicators during this period; to identify genetic, personal, family, school, and social/environmental factors that promote or sustain positive health behaviors; to identify transition points in health risk and risk behaviors and changes in family, school, and social/environmental precursors to these transitions, and to examine the role of potential gene-environment interactions in the development of health status and health behaviors. . This study collects reliable and valid data on health behaviors and health indicators and their social, environmental, and biological contexts beginning with a nationally representative probability cohort of 10th-grade children in the U.S in 2009 and following them through 2016. Measures are collected annually for seven years beginning in the 2009-2010 school year and ending in the 2016-2017 school year. African-American youth are oversampled to provide better population estimates of this group and to provide an adequate sample to examine racial/ethnic differences in longitudinal predictors of health, health behaviors, and health behavior change. Hispanic youth do not require oversampling because they currently represent a sufficient proportion of the population of adolescents to provide an adequate sample to examine racial/ethnic differences. Self-reports of health status, health behaviors, and health attitudes are collected by in-school and online surveys. Anthropometric data, genetic information, and neighborhood characteristics are gathered on all participants as well. The study also incorporates an Administrator Survey and other data sources to obtain related information on school-level health programs and community-level contextual data. The NEXT Generation Health Study data support NICHD, National Heart, Lung and Blood Institute (NHLBI), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Maternal and Child Health Branch of the Health Resources and Services Administration (HRSA/MCHB) in fulfillment of program requirements that address supportive health environments for adolescents and young adults. In addition, a representative subsample of overweight and normal weight adolescents has been identified: additional data on behavioral risk factors and biological markers and risk factors are gathered on these adolescents. Driving performance will also be evaluated in 150 young adults.
The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities. * The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues. * The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness. * The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population. * Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.
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.
The New Jersey Physicians Advisory Group (NJPAG) previously created the Yes You Can...Make Smart Choices! (YYC...MSC!) program with the goal of preventing teen pregnancy and enhancing character development in youth. YYC...MSC! is a fully developed intervention that NJPAG has experience implementing that is grounded in a theoretical framework with promising evidence of effectiveness. However, this intervention has not yet undergone a rigorous evaluation with a control or comparison group. This evaluation aims to conduct a randomized control trial (RCT) to determine the program's effectiveness. This evaluation will focus on the entire PREIS planned intervention, YYC...MSC!. The intervention will be implemented in 13 Newark Public Schools in New Jersey, including Weequahic High School and Newark School of Global Studies. Findings from this study will expand the evidence base on adolescent pregnancy prevention through this innovative program. After the study, findings will be disseminated to encourage program interest, support, and adoption in real-world service systems or communities, including schools. The primary research question is, "What is the effect of the 2-week YYC...MSC! program on 9th grade students in Northeast urban school districts' reports of engaging in sexual intercourse 12-months after the pre-survey compared to those that do not receive the program?" The outcome for the primary research questions is sexual intercourse in the last 3 months and the domain is sexual activity.
The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.
This pilot study aims to assess the feasibility, acceptability, and effectiveness of using nitrous oxide (N2O) sedation for intrauterine device (IUD) insertions for nulliparous adolescent and young adult women in a primary care clinic setting.