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NCT07547696
The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.
NCT06670066
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
NCT03694418
N/E is a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, constructed on Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire to implement a holistic SRH intervention for American Indian youth. N/E includes: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase communication between adult family members and youth about SRH topics; 3) a cultural mentoring component at the community level that pairs American Indian youth with adults and elders to discuss traditional American Indian beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at the systems level in Fort Peck to coordinate SRH services for American Indian youth. The overarching aim of this proposal is to refine, tailor, and finalize the components of N/E and evaluate its efficacy. We will use a cluster-randomized stepped-wedge design (SWD), in which 5 schools that American Indian youth from Fort Peck attend are the clusters to be randomized into the intervention 1 at a time, with all schools eventually being randomized to the intervention. The 5 schools are located in separate communities, mitigating the potential for cross-contamination. N/E is a 5-year study involving 456 14- to 18-year-old American Indian youth.
NCT05514730
Relatively little is known about the treatment of problematic sexual behavior (PSB) displayed by preteen children. Randomized controlled trials (RCTs) examining potential treatments are rare and the available results to date are generally underwhelming. A new protocol, termed Phase-Based Treatment (PBT) for Preteen PSB, has shown positive results in an early stage pilot and during community implementation efforts. This trial will be the first RCT of PBT and aim to determine whether PBT might outperform a treatment-as-usual condition.
NCT05022134
This is a prospective study involving two phases: 1) adaptation and 2) intervention, in adolescents aged 14-21 experiencing homelessness. The overarching goal is to develop and evaluate the effectiveness and feasibility of a counselling intervention to improve access to contraception among AYA experiencing homelessness. During the first phase, referred to as the adaption phase, we will rely on collective input from formative groups of AYA experiencing homelessness to adapt the CHOICE counselling intervention for this underserved and under-resourced population. In the second phase, referred to as the intervention phase, we will evaluate the effectiveness and feasibility of the adapted intervention (CHOICE-AYA).
NCT06913660
This is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with HIV (ALHIV) ages 15-21 in Kisumu, Kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).
NCT07102303
The goal of this clinical trial is to study the effectiveness of an online group therapy to treat people with cybersex addiction or online sexual compulsivity. It will compare group therapy to individual therapy. It uses cognitive behavioral therapy, a therapy that aims to change thoughts and behaviors. In this case, the therapy will train participants in coping strategies that allow them to control their sexual impulses. The main questions it aims to answer are: Is online group therapy effective to treat cybersex addiction/online sexual compulsivity? How does group therapy compare to individual therapy? Researchers will compare the results of participants in group therapy to those in individual therapy and those who receive no treatment. Participants will: Attend evaluation sessions Attend therapy sessions once per week for 12 weeks Keep a weekly diary of their sexual behavior Complete follow-up surveys 1 week, 3 months, 6 months, 9 months, and 12 months after treatment
NCT06276595
The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. This project will evaluate the impact of "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use.
NCT06406296
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of problematic chemsex.
NCT02432352
The purpose of this study is to assess the feasibility and acceptability of a family-based preventive intervention designed to reduce sexual risk behaviors and depressive symptoms among South African adolescents and their parents/guardians/caregivers.
NCT06951555
Cybersex addiction, understood as a subtype of Internet addiction or a manifestation of Compulsive Sexual Behavior Disorder, is a growing phenomenon. Recent studies developed by our research group have revealed that about 10% of young people in Spain could be at risk of suffering or already suffer from this problem, which can lead to consequences beyond the addiction or compulsive behavior itself, such as low self-esteem, emotional problems, sexual dysfunction, infidelity, breakups, social isolation, development of paraphilias, increase of risky sexual behavior, problems with the law, etc.. Although some studies have been carried out so far, especially on the prevalence and characterization of the sociodemographic and psychological profile of people with this disorder, psychological intervention programs for this problem have hardly been developed, and studies on the effectiveness of such programs are very scarce. Furthermore, seeking psychological help for people with this type of problem is infrequent due in part to the stigma associated with sexual addictions. In this sense, e-health approaches can reach a potential audience of users who would not access treatment if they had to physically visit a clinic. For this reason, the present project seeks to evaluate the efficacy of an online intervention aimed at the treatment of cybersex addiction or online sexual compulsive behavior disorder in the general population. For this purpose, a sample of 100 patients with a risk or pathological profile will be randomly assigned to an experimental (n=50) or control group (n=50) with similar characteristics. All of them will undergo an online assessment. The experimental group will receive an individualized online program of twelve one-hour sessions. The study will be based on an experimental design of comparison between groups (experimental-control) with pretest-posttest-follow-up evaluation at 1 month, 3 months, 6 months and 12 months, to evaluate the efficacy of the intervention. For this purpose, descriptive and differential statistical analyses (t-tests and repeated measures ANOVA), Cohen's d test for effect size and regression analysis will be performed.
NCT06579781
Child Trends will conduct a randomized control trial evaluation of Parent Toolkit 2.0, an innovative intervention for parents and caregivers of middle and high school students. Child Trends will collaborate with Morehouse School of Medicine and Tressa Tucker \& Associates, LLC to implement and evaluate the program with 1,000 parent-teen pairs across Georgia. The program includes three components that will be delivered across a three-week period: (1) an online self-paced Parent Guide with information, tips, tools, and resources on adolescent health, including sexual health; (2) four videos modeling parent-teen communication around sex and contraception; and (3) two group-based sessions for parent participants to discuss program content and improve communication skills. The program aims to increase parent knowledge and parent-teen communication about adolescent health, sexual health, and relationships to help youth adopt health-promoting behaviors such as delaying sexual initiation and increasing contraceptive use.
NCT06408545
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of problematic chemsex. As a pilot study, the intervention will be tested in a small group.
NCT04272853
Achieving the correct quantity and quality of sleep is essential for the health and recovery processes of the athlete; night rest is often negatively influenced by many variables, including: high training loads, long-range trips, evening competitions, and / or high levels of anxiety and stress. High training loads can therefore have negative influences both on sleep but also on the risk of injury in athletes. Understanding and studying, in different sports, how sexual / masturbatory activity can influence sleep has primary importance for athletic and medical staff of athletes with the ultimate aim of preserving sports performance and reducing the risk of injuries. The primary objective of this experimentation is to explore the perceived relationship between sexual activity (or masturbation), sleep quality and sleep latency in a population of athletes.
NCT06764901
1. Summary The STOP-CSAM Study is a two-armed randomized controlled trial of a non-pharmacological Therapy Chat Service for prevention of Child Sexual Abuse (CSA) and Child Sexual Abuse Materials (CSAM) in self-referred and self motivated patients with high frequent CSAM use and non-detected by the legal authorities. 2. Trial design This study is a prospective multicentred, stratified, parallel-group superiority study conducted in Germany, Czechia and Spain. 3. Background There has been a significant increase in child sexual abuse material (CSAM) on the internet in recent years. The use of CSAM is problematic especially because it creates a demand for and maintains contact child sexual abuse. Unfortunately, despite the significant increase in the number of CSAM users, limited resources are available for investigation and prosecution. Consequently, many users remain in the community, with neither intervention from the criminal justice system, nor the health system. The proposed study will examine whether a therapy chat service (TCS) intervention reduces the demand for, circulation and spread of CSAM in undetected offenders, as compared to a control group. 4. Methods The sample consists of individuals aged 18 years or older (expected N = 630), who have used CSAM in the prior two weeks and are seeking help voluntarily. Participants will be randomized to (1) a Therapy Chat Service (TCS) intervention or (2) a four-week waitlist (control group) followed by a TCS intervention. The TCS intervention group will receive four to six one-hour online therapy chat sessions over the period of four weeks, while the control group will remain on a waitlist for these four weeks before receiving the same TCS intervention. Assessments will be conducted at baseline (pre-intervention) and at 4-, 8-, 12- and 16-weeks post-intervention. The main objective of the study is to compare the effectiveness of TCS in the prevention of CSAM use within a sample of self-referred participants. The primary outcome is the significant decrease of CSAM consumption, which will be assessed by comparing self-reported severity and time spent using CSAM in the two weeks before the intervention and at four weeks following the intervention. Potential progress measures include time spent, severity and frequency of CSAM consumed. Psychological wellbeing and total sexual outlet will be also measured as secondary outcomes, other participant variables such as risk factors for CSAM consumption or sexual interests and therapeutic variables such as number of patient-therapist interactions, modules covered per session, common factors of psychotherapy, adverse effects of intervention and dropout rate will be also measured. Outcomes between groups will be compared following standard principles for RCTs. 5. Results The study will open for recruitment in October 2023, and data collection is expected to be completed by November 2024. The results for the primary outcomes are planned to be analysed by December 2024 and submitted for publication by the end of the project in March 2025. 6. Discussion The study will test whether the TCS intervention has a positive effect, not only in terms of reducing self-seeking potential sexual offenders' problematic sexual behaviours, but also on measures such as psychological wellbeing in CSAM users. Possible adverse effects of TCS intervention will also be assessed. Recently, a similar trial called PRIOTAB-CBT, compared pre- and post-treatment outcome measures between a treatment group to a control group (Lätth et al., 2022). Results showed a significantly larger reduction in time spent using CSAM in the treatment group, in comparison to the control group. PRIOTAB-CBTh was a single-centre, single-blinded, psychological placebo-controlled RCT of an online cognitive behavioural psychotherapy. If the STOP-CSAM trial demonstrates that a TCS intervention reduces CSAM use, it could be an effective prevention strategy for sexual violence against children. 8\. Funding European Commission - Internal Security Fund (ISF-2021).
NCT05954130
Pregnancy is an important process with many changes in a woman's life. During this period, the sexual lives of couples may be affected due to anatomical, physiological and psychological changes. While sexual intercourse during pregnancy strengthens the harmony between spouses, emotional bond, and self-confidence of the woman, its role is important in terms of the continuation of the marriage. The development of technology in the world and in our country has led to an increase in the use of mobile devices. The emergence of telehealth and mobile applications with the Covid-19 pandemic has enabled individuals to access information whenever they want and more easily. The aim of this study was to determine the effect of mobile application support given to pregnant women for sexual health on sexual function and quality of sexual life. It is planned to develop a mobile application in this direction by preparing a guide, with the foresight that sexuality during pregnancy is not an easily expressed subject and that pregnant women and health workers need training materials. After the power analysis, it is aimed to reach a total of 70 people, 35 in the experimental group and 35 in the control group. Data will be collected with Personal Information Form, Female Sexual Function Index, Sexual Life Quality Scale and Qualitative Interview Form. Based on the developed guide and mobile application, training will be given to pregnant women in the first, second and third trimesters, and it is thought that the mobile application support specific to sexual health during pregnancy may contribute to increasing sexual function and sexual life quality.
NCT01088542
The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.
NCT06485284
The goal of this randomized controlled trial is to evaluate the impacts of El Camino, a goal-setting sexual health promotion program targeted toward Latino adolescents. The primary research questions are: * Research Question 1: Is participation in the El Camino goal setting program associated with greater abstinence (measured as never had sex, no recent sexual activity) relative to a comparison group that did not receive El Camino? * Research Question 2: Is participation in El Camino associated with reduced unprotected sex (measured as sex without any method of contraception, sex without a condom) for the intervention group relative to the comparison group? Researchers will compare those who received El Camino to a comparison group who received an alternative program that does not include sexual health components. As part of the study, participants will be asked to: * Attend approximately 11 hours of programming completed over 11 weeks * Complete baseline, post-intervention, and 12-month follow-up surveys * For select participants who received the El Camino program, participate in an optional focus group discussion
NCT06443268
The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers. The main question is: • to discover the factors associated with quality of life and stress in patient-caregiver dyads. Participants will be asked to fill out questionnaires and agree to provide a hair sample (in order to measure stress hormones in hair) and consent to use of their routine clinical and laboratory data. Researchers will compare a group of participants without stroke to establish a comparable baseline.
NCT04762381
Robotic-assisted hysterectomy is an alternative to laparoscopic surgery as part of a minimal invasive regimen. Several treatment strategies are followed to improve the overall outcome and minimize surgical stress. Glucocorticoids provide significant analgesic and antiemetic effects but its role in a fast-track, multi-modal setting is not settled when discharge is planned within 24-36 hours. This study will evaluate in a randomized trial the effect of a single dose of 24 mg dexamethasone on women undergoing robotic-assisted hysterectomy with regard to surgical stress measured by c-reactive protein as primary outcome and, further, other stress markers like white blood cells. The postoperative recovery will be registered in validated charts and questionnaires for pain and analgesic use, quality of recovery, incontinence, sexual and work life. Furthermore, in a sub-analysis, transcriptional profiling will be applied to explore, which parts of the innate and cellular immune system is activated to explore the mechanisms of surgical stress response. The hypothesis is that women undergoing robotic hysterectomy would benefit from peroperative glucocorticoid treatment on important life qualities like pain, fatigue, freedom of medications and resuming work and sexual activities. Further, future adjuvant peroperative regimens may be able to target the stress response in a more appropriate way