116 Clinical Trials for Various Conditions
Alternatives For Girls (AFG's) EmpowHer curriculum is a program for pre-and early middle school girls (ages 10-15). The curriculum is gender-specific (girls), youth-co-led, and innovative (using online platforms and digitized presentation of material that targets minority/high-risk African American and Latina girls). EmpowHer addresses four adulthood preparation subjects (APS), such as parent-child communication, healthy relationships, adolescent development, and healthy life skills, and is implemented as an after-school program.
The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.
The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is: (RQ1a): What is the effect of adding 4.5 hours of Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 9th and 10th graders compared to the students receiving only the 14-hour-long Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the 14-hour-long Relationship Smarts Plus curriculum on rates of unprotected sex among 9th and 10th graders compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection. The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)
Children's Hospital Los Angeles and ETR will implement and test the effectiveness of a pregnancy prevention intervention, My Future Self, targeting youth ages 16-19 in Los Angeles and San Diego Counties who, for a variety of reasons, are receiving education or training in non-traditional settings. These youth typically experience a combination of needs related to unstable or no housing, extreme poverty, involvement with child welfare or juvenile justice, historical trauma, and/or learning differences. My Future Self is a 5 week program consisting of 5 group sessions. Our study will enroll up to 704 highly mobile youth from various sites in Los Angeles and San Diego. Youth will be randomized to receive the My Future Self intervention in conjunction with their regular services or just their regular services. All youth enrolled will complete baseline, 6 month and 12 month surveys.
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely. Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health. The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.
Manhood 2.0 is a male-only group-level intervention, delivered over 13 hours, based on social cognitive theory, social norm theory, theory of gender and power, and the theory of reasoned action. The intervention is a gender-transformative program that promotes critical reflection and awareness on reproductive health, healthy relationships, gender norms and stereotypes that drive reproductive health behavior, and explicit and proactive support of female partner contraceptive use. Activities include group discussion, role playing, knowledge sharing, and skill-building; their purpose is to challenge young men to think critically about social expectations and restrictive norms, engage in dialogue about these gender norms, and then assess the way rigid norms affect their attitudes and behaviors toward a number of key issues, including intimate relationships, gender-based violence, substance abuse, sexually transmitted infections, and early pregnancy. Young men receive the intervention at a local community center or high school. Comparison condition young men receive a post-high school readiness program that does not discuss gender norms or sexual and reproductive health. The study was conducted with six cohorts of eligible young men ages 15-18 who received a baseline, immediate post-intervention, and three-month post-intervention survey. To participate in the study, individuals had to meet all the following criteria: (1) Identify as male; (2) Ages 15 to 18; (3) Not actively planning a pregnancy with someone; (4) Never participated in the community center's sexual and reproductive health program; (5) Received no additional sexual or reproductive health programming in the last three months; (6) Able to participate in a program delivered in English only. The investigators hypothesized that Manhood 2.0 participants would have lower rates of unprotected sex and more equitable attitudes towards gender than comparison participants.
The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female adolescents and their female caregivers. Specifically, investigators aim to evaluate the impact of "Asdzaan Be'eena'" or Female Pathways in English (henceforth referred to as AB) on risk and protective factors for early substance use and sexual debut through a randomized controlled trial (RCT) in partnership with the Navajo Nation. The program was developed and pilot tested through an extensive formative phase conducted by our tribal-academic partnership (IRB protocols: #00006569 and #00009117). Investigators will examine the efficacy of the AB program for reducing risk factors and improving protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use.
A multi-site randomized trial. Adolescents enrolled in this Clinical Trial will be enrolled into one of two arms. Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the Multi-level intervention arm will be offered immediate Emergency Department based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care).
Investigators will assess the preliminary effects of Girls Invest, an innovative savings intervention that aims to reduce economic, social, and health behavior risks associated with disproportionately high rates of pregnancy among US Latina adolescents. Girls Invest involves a multidisciplinary conceptual model adapting the most effective prevention strategies from the disciplines of public health and economics. Participants receive a savings account (via our collaborating bank) with $100 deposited in increments based on completion of each module of a gender and life skills training via a mobile "app."
This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).
This study used a randomized controlled design to evaluate the efficacy of a new mobile app, Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based mobile health application that can be accessed through mobile smartphones and computers. Pulse was designed to increase highly effective birth control use and reproductive and sexual health care utilization, and ultimately decrease teen pregnancy. The sample was comprised of 2,317 women aged 18-20 who, at enrollment, were not pregnant or trying to become pregnant, had daily access to a smartphone, were currently living in the United States or a U.S. territory, and spoke English. Most of the sample (86%) identified as Black and/or Latinx. The evaluation team enrolled participants over a two and a half year enrollment period using social media, including Facebook and Instagram. Users accessed Pulse autonomously, on their own terms, and in their own time and place. The app consists of 6 sections and includes 3 hours of unique content. It does not require the user to follow a specific sequence of content viewed; however, all users received a monetary incentive after registering with the app. Young women randomized to the intervention condition were given access to Pulse indefinitely and received daily text messages related to sexual health for 6 weeks. Control participants were directed to a free general health/fitness web-based mobile application, also called Pulse, and received text messages related to general health for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain different content. Participants in both the intervention and comparison groups received a baseline survey, a 6-week follow-up survey, and a 6-month follow-up survey (the 6-month follow-up survey was only administered to participants recruited between November 2018 and March 2019). Participants also received incentives for completing the baseline and post-intervention surveys. Both surveys were conducted online via an electronic survey platform. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.
The purpose of this study is to find out if information and support provided with a mobile-delivered (via iPad) momHealth Teen Pregnancy Program can promote healthy choices and behaviors during and after pregnancy.
The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations \& Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.
Alternatives For Girls (AFG) is offering LeadHer as a gender-specific teen pregnancy prevention curriculum to girls between the ages of 14-19 years old who live in Wayne County, MI. The curriculum seeks to demonstrate that girls who participate in LeadHer will show increased rates of avoidance of unprotected sex, will show increased use of birth control and reduced rates of pregnancy. LeadHer will run over a 6-session period covering topics designed to prevent teen pregnancy and develop girls into leaders. The sessions will be co-led by youth (Peer Educators).
This study uses a randomized controlled design to evaluate the efficacy of a new mobile app, Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based mobile health application that can be accessed through mobile smartphones and computers. Pulse was designed to increase highly effective birth control use and reproductive and sexual health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of women with the following characteristics at study enrollment: aged 18-20, not pregnant or trying to become pregnant, has daily access to a smartphone, currently living in the United States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to enroll up to 1,300 participants over a one-year enrollment period using social media, including Facebook, Instagram, and Twitter. Users access Pulse autonomously, on their own terms, and in their own time and place. The app consists of 6 sections and includes 3 hours of unique content. It does not require the user to follow a specific sequence of content viewed; however, all users will receive a monetary incentive after registering with the apps. Youth randomized to the intervention condition are given access to Pulse indefinitely and receive daily text messages related to sexual health for 6 weeks. Control participants are directed to a free general health/fitness web-based mobile application, also called Pulse, and receive text messages related to general health for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain different content. Participants in both the intervention and comparison groups receive a baseline survey and a 6-week follow-up survey. Participants will also receive incentives once they complete the baseline and post-intervention survey. Both surveys are conducted online via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and peer educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes either received an alternative program that focused on health, nutrition, and fitness, or business as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.
50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.
The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB women ages 14-18 years, nation-wide. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is associated with increases in TPP behavior.
The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.
Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.
While the U.S. teen birth rate is currently at its lowest level, it remains high in relation to other industrialized countries and continues to be a public health concern due to health risks for teen mothers and their babies, and associated social and economic costs. Parental monitoring, supervision, and open communication about sexual issues have been found to be protective factors for adolescent sexual activity and pregnancy. Our theoretically based Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is designed to build parental communication, knowledge, and attitudes to discuss sensitive topics with their child, including sexuality, pregnancy prevention, and preventing sexually transmitted illnesses (STIs). This age group of children was selected because parental communication about pregnancy and STI prevention will be most effective if initiated prior to, rather than after, the age when children commonly become sexually active. The "Let's Talk about Sex" program is grounded in behavior change theory and incorporates the use of video for behavioral modeling and emotional support.
This study is comparing the impact of two teen pregnancy prevention interventions, Reducing the Risk and Love Note with a non-related training on community building to determine which is most effective for which participants in delaying sexual initiation, enhancing use of condoms and other forms of birth control, decreasing sexually transmitted diseases and decreasing the number of pregnancies. The participants were 1450 youth between the ages of 14 and 19 including those from poor urban settings, those from immigrant and refugee families and those from the foster care system. Both girls and boys were be in the study. The investigators predict that girls, immigrants and refugees and foster youth will have better outcomes when participating in Love Notes, a program focused on healthy relationship formation and maintenance as a frame for how to manage the sexual aspect of relationships while boys and urban youth will have better outcomes when participating in Reducing the Risk. Both groups will have better outcomes than those in the control condition.
The purpose of the study is to evaluate the effects of different dietary calcium have on the pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during pregnancy will result in higher bone mass in the newborn.
This is a randomized clinical trial assessing the efficacy of two types of counseling (Computer-Assisted Motivational Intervention \[CAMI\] versus Didactic Educational Counseling \[DEC\]) to see which can better reduce female adolescents' risk taking behaviors that put them at risk for unintended pregnancy and sexually transmitted diseases (STDs). The intervention phase consists of three 30-minute counseling sessions over the first 6 months followed by a visit every three months during the 12 month follow up phase. We, the researchers, hypothesize that the CAMI will decrease the proportion of subjects who engage in any intercourse that is poorly protected against pregnancy and against STDs.
The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is: Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse? Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)). Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.
The goal of this randomized trial is to learn if the Are You Ready? (AYR) intervention has a positive impact on the sexual and mental health behaviors of sexually active youth between the ages of 14 and 21 years old who are at risk for or involved in the juvenile justice and/or child welfare systems. The primary research questions it aims to answer are: * Three months after being offered the intervention, does AYR impact youth's receipt of sexually transmitted infection testing in the past three months? * Three months after being offered the intervention, does AYR impact youth's use of coping skills? * Nine months after being offered the intervention, does AYR impact youth's frequency of having vaginal and anal sex without condoms in the past three months? Researchers will compare participants randomized to receive AYR (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered AYR as a virtual or in-person, 2.5 hour group session. Participants randomized to the control group will be offered a virtually delivered control condition.
The goal of this randomized trial is to learn if the Stepping Stones (StSt) intervention has a positive impact on the sexual health and relationship behaviors of sexually active youth between the ages of 12 and 22 years old who are at risk for or involved in the legal or child welfare systems. The primary research questions it aims to answer are: * Three months after being offered the intervention, does StSt impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does StSt impact youth's frequency of having vaginal and anal sex without condoms in the past four months? * Nine months after being offered the intervention, does StSt impact youth's perpetration of emotional abuse in the past four months? Researchers will compare participants randomized to receive StSt (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered StSt as an-person, individual-based intervention delivered over four sessions during a 6-8 week period. Participants randomized to the control group will be offered a virtually delivered control condition.
The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the legal system. The primary research questions it aims to answer are: * Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months? Researchers will compare participants randomized to receive Unstained (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.
The purpose of the study is to determine the impact of the offer to participate in the Young United Parents! (YUP!) intervention relative to the control condition on use of effective non-barrier contraception and frequency of vaginal sex without condoms three months after the intervention period has concluded.