28 Clinical Trials for Various Conditions
The purpose of this study is to explore the effectiveness of the Injeti Self-Esteem Model (ISEM) with a psychoeducational therapy intervention for improving self-esteem among university students. To explore the effectiveness of the ISEM (see Appendix A), investigators are utilizing a mixed method study design to acquire both quantitative and qualitative data to view effectiveness through measurable outcomes and personal experience. The intervention will involve a 1-hour session, which will include administration of the ISEM.
This study will explore the effects of the Injeti Self-Love Model intervention on adolescents challenged with low-self-esteem leading to self-harming, suicidal thoughts and suicidal attempts. This study will examine the promotion of self-esteem through the Injeti Self-Love Model as a safety measure against "poor behavioral habits" such as intentional self-harming, substance abuse, suicidal thinking and suicide attempt as means to cope. Study participation will include initial screening, self-assessment, occupational therapy self-esteem intervention of one session, with an individual follow-up, along with an interview, and finishing up with a one-month follow-up interview. The qualitative research is a methodology for investigating and considering the meaning individuals attribute to a significant human experience. The qualitative approach will be structured around a semi-structured interview initiated at the end of the second follow-up session and after 1-month follow-up.
The study will seek to determine whether there is a corresponding deficit in school performance for teenagers with NF1. Secondly, the study seeks to explore the issue of self-esteem in teenagers with NF1.
The objective of the Efficacy Study of Amazing Me Program is to deliver the Amazing Me intervention and assess its efficacy. The Amazing Me intervention aims to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. The Amazing Me intervention teaches students to be kind to themselves, their bodies, and to others.
The proposed research will used community-based participatory research methods in an urban-based American Indian (AI) community to adapt, implement, and evaluate an after-school program, called Native Spirit (NS), that seeks to improve cultural identity, self-esteem, resilience, and prevent substance use by increasing cultural engagement. Prior research suggests that AI youth that are culturally engaged experience better health outcomes. Additionally, the use of culturally-specific after-school programs has been shown to increase feasibility and sustainability of prevention programs. In order to achieve the goals of this proposed study, the Principal Investigator (PI) will work with local community members and existing tribal partners to implement the 10-session culturally-grounded after-school program and evaluate the program with the following aims: Specific Aim 3 (R00): Examine the effectiveness of NS (increases exposure to local cultural values and activities), a program that seeks to prevent or decrease substance use by strengthening self-esteem, resilience, and cultural identity with 2 Indigenous communities in Arizona using a wait-list control design with 3 data collection timepoints and participant interviews.
The goal of this clinical trial is to evaluate an adapted version of the radKIDS® Personal Empowerment and Safety Education Program in randomly assigned 4th grade classrooms. The primary hypothesis is that students in the radKIDS study arm will have significantly higher growth in safety knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem compared to classrooms in the business as usual condition. At the student level, researchers will compare 4th grade students in classrooms randomized to receive the radKIDS program to those in classrooms receiving their regular instruction. Student participants will complete two surveys a few months apart assessing safety knowledge, self-efficacy, and self-esteem. In the radKIDS2.0 arm, students will receive the radKIDS program between the two surveys. In the control arm, students will receive instruction as usual.
The Dove Self Esteem Project, has provided our research team with funding to develop a 60- minute workshop for Hispanic/Latinx Youth between the ages of 11 to 16 years old that builds body confidence. This workshop was developed based on prior curriculum the investigator has developed for The Dove Self Esteem Project and designed with two teachers and several adolescent children. The aims of the current study are to: 1) examine the efficacy of the workshop, and 2.) evaluate the extent to which children like the curriculum and find it useful. Children will be randomized to control group or intervention group; however, the control group will eventually go through the workshop after 2 surveys. It is hypothesized that children in the intervention group will report higher body satisfaction scores, greater self- esteem, more awareness of body talk and less engagement in appearance comparisons relative to the control group. It is hypothesized that children will report liking the workshop, finding it useful and engaging.
This study will consist of an experimental group and a control group. Approximately 150 adult males and females from the ages of 19+ will take part in this study. Subjects will be divided into a Control and Experimental Group. Subjects for the control and experimental group will be recruited from our internal database of subjects who have previously shown interest in studies and from userinterviews. Subjects in the experimental group (RPM Group) will be admitted to the Tony Robbins Rapid Planning Method (RPM) virtually at no cost, while the subjects assigned to the control group, will not attend the event, but instead be required to regularly complete journaling involving a to-do-list of their weekly work tasks. Psychological assessment surveys will be taken before the event, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention. The control group will take the psychological assessment before beginning journaling, and at 1 week (day 8-13), and 4 weeks (day 29-34) post intervention.
The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in youth institutionalized for behavioral and emotional problems. We are using two study sites, Lawrence Hall and Lydia Home, both Chicago-based residential treatment centers for youth with behavioral and emotional problems, many of whom have experienced child maltreatment and trauma. Comparisons will be made to a matched sample of youth from Lawrence Hall and Lydia Home receiving treatment as usual. Results from this project will provide preliminary evidence of whether a structured, goal-oriented intervention program focused on dog training activities has direct impact on increasing youth emotional self-regulation, impulse control, and self-efficacy, which are important targets for intervention among youth with mental health problems. If successful, this project could lead to a larger, randomized control clinical trials study that tests the longitudinal impact of the program that could further lead to national dissemination of the Recovery \& Care curriculum as an alternative therapeutic approach.
The purpose of this study will be to examine the effectiveness of an application-based lifestyle change program on body composition, body shape, body, image, and self-esteem in females following a 6-week period. The study will be carried out in a randomized, placebo-controlled, parallel manner. Participants will be stratified into quartiles based on their body mass indices during screening and prior to baseline testing. Participants from each quartile will be randomly divided by into experimental or control conditions. Following randomization, participants will be baseline assessed on their body composition using a whole body Dual Energy X-Ray Absorptiometry scan, on their subjective measures of body shape and image using a variety of questionnaires, blood chemistry panel, and lower-body strength using a isometric mid-thigh pull dynamometer. Following baseline testing, participants will undergo 6-weeks of following their respective condition. Participants will be instructed to follow their group-specific guidelines for the 6-week period to the best of their ability. Body shape and image questionnaires and assessments of body composition, blood chemistry, and lower-body strength will be conducted following the week 6 to conclude the study.
The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in Lawrence Hall, a Chicago-based residential treatment center for maltreated youth. In this study, the investigators test the feasibility, acceptability, and short-term efficacy of expanding the program to a group of youth currently in outpatient treatment for social, emotional, and behavioral problems. Results from this project will provide preliminary evidence of whether a structured, goal-oriented intervention program focused on dog training activities has direct impact on increasing youth emotional self-regulation, impulse control, and self-efficacy, which are important targets for intervention among youth with mental health problems. If successful, this project could lead to a larger, randomized control clinical trials study that tests the longitudinal impact of the program that could further lead to national dissemination of the Recovery \& Care curriculum as an alternative therapeutic approach.
Participants (random) will have a conversation with each other over zoom initially with their cameras off and then rate each other on attractiveness, first impressions, and self-esteem. Then both participants will turn their cameras back on and have another conversion and then again rate each other. The ratings are confidential and will not be shared with the other person. Two months later the participants will come to the study clinic office and have an in-person conversation with someone new and rate each other.
Higher rates of depression are reported by autistic adolescents as compared to their non-autistic peers, which is problematic given adverse outcomes (e.g., negative self-esteem, lower academic performance) that are associated with depression. Despite the alarming rates of depression in autistic youth and associated safety concerns, few treatments have been developed. In this study, we investigate the feasibility, acceptability, and preliminary efficacy of an autism-adapted group cognitive-behavioral treatment for autistic adolescents (11-17 years old; middle and high school) in a pilot, nonrandomized trial. Specifically, we aim to increase adolescents' perception and understanding of self, including autistic identity, in order to treat depression. Intervention design and implementation were guided by autistic self-advocates and parents.
Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer. Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this. Clinical-community partnerships are well-positioned to address this care gap. This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting. In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic. Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase. The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change. A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.
The purpose of this study is to test the feasibility of a stigma reduction intervention in Human Immunodeficiency Virus(HIV)-positive women using a video of first-person narratives delivered via personal Ipod Touch.
The purpose of this study is to evaluate the impact of a 4-week art therapy intervention on the relationships between individuals diagnosed with Alzheimer's disease and their care partners, on the self-esteem of diagnosed individuals, and on care partner attitudes towards persons with Alzheimer's disease.
As the population ages, there is increasing interest in developing innovative approaches to promote and sustain mental and emotional well-being. Recent studies have linked engagement with the arts with supporting cognitive functioning, promoting empathy and greater sense of life purpose. The need to develop alternative approaches to sustain emotional well-being is especially acute for the nearly 6 million older Americans who suffer from Alzheimer's disease. There is a need for quality activities that can be done virtually for homebound individuals with cognitive disorders and the individuals' family care-partners. The investigators intend to institute a 3-session virtual art museum pilot program for seniors with cognitive disorders and care-partners using the Visual Thinking Strategies approach. The investigators hypothesize that participation in a virtual guided visual arts experience will enhance emotional well-being and self-esteem for both seniors with cognitive impairment and the seniors' care-partners.
Investigators propose a cross-sectional, observational pilot study to examine the contribution of stress, family dynamics, and peer relationships to quality of life (QOL) in adolescents with Tourette syndrome (TS). Investigators will recruit two groups of participants: 1) adolescents aged 13-17 years of age with TS and 2) adolescents aged 13-17 without any neurologic or psychiatric diagnoses. Participants and one of their parents/caregivers will complete a series of questionnaires screening for and quantifying the extent of stress and mental health symptoms, including anxiety, depression, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD). Participants will also complete instruments characterizing family interactions and peer relationships. Adolescents with TS will also undergo a semi-structured interview assessing the severity of their tics.
This was a randomized controlled pilot trial to evaluate clinical efficacy and feasibility of hatha yoga as a mono-therapy for major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal/nutraceutical mood therapies, or mind-body practices were excluded. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from intervention start at 0 weeks until finish at 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at 0 weeks and 8 weeks. Blinded assessors analyzed whether change in outcome measures would be statistically comparable between the two intervention groups.
This project focuses on social and character development of elementary and middle school-aged children and responds to an urgent national need that schools improve their capacity to address a range of student outcomes, including social skills, character, behavior, academic achievement and health outcomes. This study is a school-based randomized trial to evaluate the Positive Action program. The Positive Action program was designed to promote social and character development and improve behavior and school performance.
The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.
Through the use of an educational intervention, the object of this study is to reduce the prevalence of bullying behaviors among fifth grade school age children. Bullying behaviors promote an environment of violence , fear, and hostility. The study will arrange to present six character education lessons in the classroom of fifth grade students in a New York City public school. Questionnaires will be administered to the students before and after all the lessons have been completed. Questionnaires will collect information about the students self perception of their levels of misconduct, impulsivity, confidence, value of non violence, ways of handling anger, opinions of their leadership behaviors, prevalence of bullying behaviors, and indications of levels of self esteem. Also, their fifth grade teachers will complete pre and post treatment student behavioral questionnaires.
This study will describe the use of an intervention, developed by an organization called Positive Exposure, to improve self-perceptions among adolescents and young adults who may encounter the stigma, or negative effect, of differences in their head and face. Photo-shoots and video interviews will be used. The combined use of those techniques is a new way to address aspects such as self-esteem, body image, and feelings of social awkwardness and anxiety-that is, a way that has never been systematically explored with people who have craniofacial differences. The conditions that participants in this study have will include cleft lip and palate, Apert syndrome, hemifacial microsomia, Treacher Collins syndrome, Mobius syndrome and Sturge-Weber syndrome. Among the goals of photography and video interviews are to help people to define themselves by their strengths rather than by their conditions; visually confront discrimination by others; investigate the possibilities for social support, networking, and creative problem-solving that can be developed for people with craniofacial conditions; and promote hopefulness for the future. Positive Exposure is a nonprofit organization founded in 1997. It investigates the psychosocial experiences of people who have genetic, physical, and mental conditions, among all ages and ethnic and cultural backgrounds of people. According to experiences of people with several conditions, participation with Positive Exposure has enhanced their feelings about themselves as attractive, capable individuals. Patients ages 12 years and older who have craniofacial conditions may be eligible for this pilot study. About 30 people will participate. Participants will be asked to provide the diagnosis of their craniofacial conditions. They will also be asked how many surgeries and what kinds they have had over the years, and how old they were at the time of the surgeries. This information will not be connected to participants' names and will be stored in a database protected by password. There are three parts to the study. In Part 1, patients will be asked to write a personal reflection (for as long as they wish) on their experiences of having their picture taken and being video taped. They will also fill out a brief survey, taking about 15 minutes. They are able to do this at home and will mail their responses to the researchers. In Part 2, they will take part in a photo-shoot (about 1 hour) conducted by the founder and program director of Positive Exposure and then take part in a video interview (about 30 minutes) conducted by a co-investigator from that organization. In Part 3, to take place 1 month following the photo-shoot, participants will write a final reflection that describes their experiences with Positive Exposure and then fill out another brief survey (about 10 minutes). Surveys used in the study will be the Self-Esteem Scale, Perceived Social Stigma Scale, and State Hope Scale. Photo-shoots and video interviews will be held at the studio of Positive Exposure in New York City or, if necessary, at a location closer to the participant's home. The projected time line of this pilot study is 10 months. Direct benefits are not the goal of participation in this study. However, participants may enjoy the photo-shoots and video interviews, as well as the process of reflecting and sharing their life and photo experiences with others. This pilot study will be a starting point for future research into Positive Exposure for adolescents and adults with visible genetic conditions.
The purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia
This study will be used to determine the effectiveness of GirlPOWER!, an innovative mentoring program for adolescent minority girls living in urban areas.
The specific aims of this study are to document the co-existence of depression, low self-esteem, and high-risk behaviors among overweight and at-risk for overweight female adolescents; and decrease the prevalence of high-risk behaviors by improving depressive symptoms/signs and self-esteem through weight management intervention strategies that encourage long-term mental and physical well being. The proposed research will test the following hypotheses: * Overweight and at-risk for overweight female adolescents have poor self-esteem that may mask depression and mediate high-risk behaviors; and * Improved weight perception decreases participation in high-risk behavior secondary to improved self-esteem and depression.
Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. There is little data to show improved long term success for the majority of participants who engage in weight loss behaviors. The specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging "Health at Every Size" (HAES). This treatment model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). The HAES model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.
Background: * Cancer has an enormous impact on the psychological and social well-being of the family unit. The life-threatening connotations of cancer single out the ill child from his peer/family group as one who is different, and often unable to maintain a normal lifestyle. Physical sequelae of cancer and its treatment accentuate the differences between these children and their normal peers/siblings. * It is important that children with cancer be prepared to function outside of protected situations and begin to develop skills of separation and independence. For healthy children, some of these latter skills are acquired by a camping experience. Such an experience for the patient with cancer is frequently precluded by their dependence on medical facilities and the physical limitations of their activities. * The goal of this study will be to assess the short and long term benefits of the "normalized" camping experience, provided in conjunction with Special Love, Inc., on the patients and staff. In particular, we will seek to determine whether such a comprehensive experience is capable of influencing the attitudes and life experiences of patients and staff in a positive manner. Objectives: -To evaluate the impact of an enriched normalized camping experience on the quality of life of the pediatric cancer patient. In particular, attempts will be made to measure the manner in which this experience influences the child's sense of well-being and self-esteem as well as his or her relationship with parents, family, and peers. Eligibility: * Children 7-17 years of age who are currently being treated for cancer or are up to 3 years post therapy OR Young adults with cancer (YACers) 18-25 years of age who are acting as counselors at Camp Fantastic * All children/young adults will be selected for camp after careful screening by a multidisciplinary committee consisting of medical and program directors. * At the discretion of the multidisciplinary committee consisting of medical and program directors, special exceptions may be made for children with extenuating circumstances. Design: * Assessment of benefit may include interviews with children and families before, during and following camp. Observational data on the child's performance at camp will be noted. * Medical and nursing personnel will consist of staff from the Pediatric Branch at the NCI, other units within the NIH, and participating institutions. * Special Love members, the Program Director at the 4-H Center camp (site of the camp) and Pediatric Branch staff at the NCI will coordinate the camp program, taking into account the medical needs of each camper. * Every attempt will be made to provide a full agenda of age appropriate activities for the patients. * The length of the camping experience for children with cancer will be for 7 days beginning on a Sunday and extending through the following Saturday morning. Patients will be transported to the camp from the NIH Clinical Center and the Virginia hospitals by bus.