Clinical Research Directory

Effect of Developmental Care on Very Low Birth Weight Infants

The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are: * Does developmental care shorten the length of hospital stay in the very low birth weight infants? * Does developmental care increase the opportunity of family centered care in the very low birth weight infants? The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units . A developmental care bundle will be tailored to meet the identified needs of participating NICUs.

Oral Health Education for Pregnant Women

The goal of this research is to investigate oral health knowledge in pregnant women receiving care at Hospital La Fe and to see whether a one-time informational intervention improves this knowledge. The main questions this research aims to answer are: What is the level of oral health knowledge among pregnant women attending Hospital La Fe? Does a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy? What factors are related to differences in oral health knowledge among pregnant women? Participants are pregnant women receiving care at Hospital La Fe. They will: Complete a questionnaire about their oral health knowledge. Receive a printed informational leaflet about oral health during pregnancy. Complete the same questionnaire again after a period of time to see if their knowledge has changed. Researchers will compare answers before and after the leaflet is provided to see whether oral health knowledge improves. They will also explore which personal or social factors are linked to different levels of oral health knowledge.

Testing the Efficacy of Safe South Africa

In this study, investigators will examine the efficacy of Safe South Africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (HIV) and intimate partner violence (IPV) among adolescent boys. South Africa faces some of the highest global rates of HIV and IPV with sustained high incidence of HIV and alarming rates of IPV among adolescents and thus, is an ideal site to advance prevention science to tackle these urgent public health priorities. Testing the efficacy of an integrated intervention to prevent HIV risk behavior and IPV for adolescent boys can support optimal health for young people, their future partners, and society.

Family Navigator Plus for Foster Parents

The investigators have designed a 5-week Family Navigator Plus (FN+) educational program to support foster parents in better understanding their youth's mental health needs and in finding mental health services. The purpose of this interventional study is to assess the the program's acceptability (e.g., satisfaction, barriers to participation, and burden), utility (e.g., how useful foster parents found the program to be), and feasibility (e.g., number referred who meet eligibility, time to complete assessments, self-reported feasibility). The investigators hypothesize that our program will be acceptable, useful, and feasible for foster parents of youth with mental health needs.

A Multifaceted Intervention to Reduce Obesity Among Preschool Children: Study Protocol for a Randomized Controlled Trial in Suzhou City

This study aimed to develop a comprehensive, multi-faceted intervention program for weight control and systematically evaluated its effectiveness on indicators of adiposity.

Connecting Families

Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Many low income families may not be receiving all the social benefits for which they are eligible. There are calls for primary care providers to ask patients if they have difficulty making ends meet at the end of the month and to intervene if poverty is identified, but it is not known if intervening can improve parent's and children's health. This study will test whether a Community Support Worker who helps families with young children navigate the social service system by reviewing social needs (like food, housing or energy insecurity) and income supports can lead to increased family income, reduced parenting stress and an improvement in their child's health. The Community Support Worker will help families complete income tax, apply for benefits and community supports for which they are eligible. The investigators will also study the effect of this intervention on health care utilization. Our study will be conducted in Toronto and Kingston in primary care practices participating in the TARGet Kids! primary care research network. Results from this study will help health care providers and policy makers understand whether Community Support Workers are an effective way to integrate the health and social service systems to improve parent and child health.

Exploring Resistance Exercise Training Plus High-Intensity Interval Training (ReHIIT) as Cancer Prehabilitation

Colorectal cancer is the fourth most common cancer in the UK. Prehabilitation, including exercise, can improve recovery from surgery. This pilot study investigates the combined effects of resistance and high-intensity interval training (ReHIIT) in healthy adults to establish baseline physiology and responses for comparison with cancer patients

Bring Sleep to Life - Evaluation and Description of a Sleep Intervention in Emergency Care

Many patients complain of poor sleep during their hospital stay. Therefore, we want to investigate how we can improve the staff's (nurses and assistant nurses) knowledge about sleep and which nursing interventions can lead to improved sleep during their hospital stay. The intervention are in three parts: a clinical guideline introduction of sleep nursing champions a web-based educational course

Effect of Culturally Tailored Health Education on Postnatal Care Use Among Postpartum Women in Ethiopia

This clinical study aims to find out if a redesigned health education program-one that respects local cultural beliefs and is based on well-known behavior change theories-can help improve how well mothers care for their newborns and how often they use postnatal care services. The main hypothesis is that culturally tailored health education provided by trained midwives will lead to: 1. Increased use of postnatal care services by mothers after childbirth, and 2. Improved knowledge among mothers about how to care for their newborns. In the study, midwives will first be trained in how to provide this culturally appropriate health education. Then, the trained midwives will deliver four health education sessions-once a month-to pregnant women during their regular antenatal (before birth) visits at health facilities.

The Effect of a Digital Board Game-Based Psychological Empowerment Program on Nurses' Psychological Empowerment Levels, Job Satisfaction, and Innovative Behaviors

Psychological empowerment is defined as nurses' perceptions of their professional roles as meaningful, their ability to effectively perform their duties, their level of participation in organizational decision-making processes, and their perceptions of their professional productivity. In occupational groups with high stress levels, such as nursing, psychological empowerment plays a crucial role in maintaining individual and organizational well-being. Research indicates that nurses' levels of psychological empowerment are moderate and that there is a need for enhancing interventions. The purpose of this study is to evaluate the effects of a digital board game-based psychological empowerment program on nurses' psychological empowerment levels, job satisfaction, and innovative behaviors. The research was designed with a pretest-posttest randomized controlled experimental design. The study sample will consist of nurses working in a university hospital. Participants will be selected according to specified inclusion and exclusion criteria, and data will be collected using a Personal Information Form, the Psychological Empowerment Scale, the Job Satisfaction Scale, and the Innovative Behavior Scale. The "digital board game-based psychological empowerment program" will be structured based on Kanter and Spreitzer's empowerment theories. The Ministry of Health's 2021 "Guide to Core Competencies in Nursing," the Psychological Empowerment Scale sub-dimensions, and studies on psychological empowerment in nursing in the literature will be considered in the preparation of the training content. The final version of the program will be completed following expert opinions. The program will consist of 6-week sessions. Each session is planned as two parts: (1) online empowerment training and (2) online group workshops. The group workshops will include topic-specific question-and-answer activities, group discussions, and digital board game applications appropriate to the session theme. Re-measurements (post-tests) will be conducted in the first and third months following the intervention. The control group will not receive any active intervention and will be subjected to the same assessment at the same time intervals as the intervention group. The control group will receive a booklet containing the training content at the end of the study. The data obtained will be analyzed using an independent samples t-test. The study results indicate a significant increase in nurses' psychological empowerment levels and an improvement in their job satisfaction and innovative behaviors in the intervention group. While numerous studies on the psychological empowerment of nurses exist in the literature, structured, long-term psychological empowerment programs and intervention studies are limited. The unique aspect of this study is the development and implementation of an innovative game-based intervention program to contribute to the psychological empowerment of nurses.

Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

Adapting An Evidence-Based Intervention To Improve HIV Testing And PrEP Uptake In Vietnam

Young men who have sex with men are experiencing an ongoing HIV epidemic in Vietnam, with an HIV prevalence of 12%. However, HIV testing and pre-exposure prophylaxis (PrEP) use among young men who have sex with men remain low. To improve HIV testing and PrEP use, mobile health (mHealth) interventions hold great promise to reach young men who have sex with men in low- and middle-income countries. HealthMindr, an evidence-based mHealth intervention developed in the United States for men who have sex with men, is an ideal option for adaptation for young men who have sex with men in Vietnam. The specific aims are to (1) Adapt the HealthMindr app to improve HIV testing and PrEP uptake among young men who have sex with men in Vietnam; (2) Examine acceptability, feasibility and preliminary effectiveness of the adapted app among young men who have sex with men in Vietnam and (3) Explore barriers and facilitators of implementing the adapted app among young men who have sex with men in Vietnam. In Aim 1, theater testing will be conducted through focus group discussions with young men who have sex with men and key other stakeholders, including health officials, clinic staff and community-based organizations. Theater testing data will be used to refine the app for beta testing. During beta testing, a small group of young men who have sex with men will use the app for 30 days, then complete an online survey and an exit interview to rate the app's usability, provide their perspectives of the app and report any other areas for improvement. App analytics will also be collected to understand whether and how the app is used. In Aim 2, the adapted app with be tested among young men who have sex with men through a randomized controlled design. Young men who have sex with men will be randomized into the intervention or control arm (1:1 ratio). The intervention arm will have full access to the app for 3 months, while the control group will receive standard-of-care HIV services. Key app features include HIV test planning, risk and PrEP eligibility assessment, ordering of free condoms and HIV test kits, information about PrEP, and PrEP provider and HIV testing locations. HIV testing and PrEP use will be assessed at baseline and 3 months and compared between groups. A mixed methods approach will be used to evaluate app acceptability and feasibility. Quantitative data on acceptability and feasibility will be collected through the 3-month online survey, while qualitative data will be collected through in-depth interviews with a subset of young men who have sex with men in the intervention arm and other key stakeholders. In Aim 3, through the same qualitative study as Aim 2, factors that influence the implementation of the app will be explored. Determinants from seven domains will be identified: condition, technology, value proposition, adopter system, health organization, wider system and embedding/adaption over time. Only when mHealth interventions are both effective and adopted can they maximize their potential to reduce HIV incidence among target populations. This proposal will generate data for designing a full-scale hybrid type 1 effectiveness-implementation trial to test the adapted app and identify implementation strategies to address the barriers of app implementation in low and middle-income countries.

Evaluating the Efficacy of a Text Messaging-based Shisha Smoking Cessation Intervention

The goal of this study is to evaluate the efficacy of a culture specific text-messaging based shisha smoking cessation intervention for young adults in Hong Kong. Participants in the intervention group will receive smartphone text messaging-based intervention and support that contained personalised messages with both text and visual elements over 6 weeks under a manualised programme. Participants in the control group will only receive a leaflet about the health risks of shisha smoking (the exact identical contents received by the participants in the intervention group at a session). All participants will complete a self-administered questionnaire at baseline, 6th- and 12th-week on their self-reported shisha abstinences, knowledge on risk, readiness to quit and attitudes on shisha smoking

The Effects of Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults

1. Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults. 2. Examine the effects of the gamified dual-task intervention on fall risk in older adults. 3. Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.

Physical Activity Routines, Education, Assessment, Literacy, and Information Technology Application in Young Children

Engaging in appropriate volumes of physical activity is important to our current and future health status. Being able to develop habits for physical activity during early years of life may have long lasting benefits throughout individuals' life course. For preschool-aged children, the World Health Organization recommends engagement in a range of activity of varying intensities (from light to vigorous intensities) for 180 minutes every day. However, one local study conducted by the Principal Investigator found that only 12.8% of children from Hong Kong met these recommendations. One key contributing factor to physical activity is one's fundamental movement skills (FMS), such as running, jumping, throwing, and kicking. FMS are considered the prerequisites or "building blocks" of many physical activities and sports. In addition to supporting an active lifestyle, researchers have shown that proficiencies in these skills are associated with better cardiovascular fitness and healthier weight statuses. Building children's fundamental movement skills proficiency from a young age is thus important. "Physical Development" is a development objective under the Hong Kong Kindergarten Education Curriculum. Hence all local preschools provide some form of education to develop children's FMS. However, most preschool teachers have not received formal training in physical education, and standardized curricula in the physical domain is currently unavailable. As such, preschool teachers' ability to instruct and assess children's development in these skills may be limited and suboptimal. Parents are significant influencers in children's development, therefore appropriate support from parents also contribute to the potential successes of the programme. In this study, we aim to address the aforementioned challenges by (1) providing preschool teachers professional development training in pedagogical knowledge and methods in the physical domain, (2) creating a set of teaching materials (in printed and digital formats) and methods that could be incorporated into the overall and preschool-based curricula, (3) creating a parental toolkit with contents mirroring the school materials, to enhance parents' knowledge and promote family-school collaboration, and (4) developing a smartphone-based artificial intelligence rating system to help preschool teachers conveniently and accurately assess children's motor skills, and provide appropriate instructional feedback.

Effectiveness of AI Chatbots in Improving Students' General Wellbeing

The goal of this randomised controlled trial is to evaluate the effectiveness of an AI mental health chatbot in promoting emotional wellbeing and perceived empathy among university students in Singapore with mild or subclinical symptoms of anxiety and depression. The main questions it aims to answer are: Can the chatbot provide emotional validation and be perceived as empathic? Does the chatbot reduce symptoms of anxiety and depression and improve wellbeing more than an inactive control condition? Researchers will compare students who engage in four sessions with the chatbot to students who complete four neutral writing tasks to assess differences in emotional wellbeing, empathy, and resilience. Participants will: Complete baseline wellbeing assessments Be randomised to: Four 20-minute chatbot sessions providing personalised support using cognitive-behavioural and compassion-focused techniques (intervention group), or Four 20-minute neutral writing sessions unrelated to mental health (control group) Complete post-session and follow-up wellbeing questionnaires All sessions are conducted virtually over Zoom. Participants are full-time students at the National University of Singapore, aged 21 and above. The study aims to inform future development of AI tools for emotional support in non-clinical settings.

Qigong and Executive Attention in Older Adults with Depressive Symptoms

The goal of this randomized controlled trial is to test whether executive attention unpacks the antidepressant effect of Baduanjin (a form of health qigong) in older adults. The main questions it aims to answer are: * Is Baduanjin an effective treatment to enhance executive attention in older adults with depressive symptoms? * Does Baduanjin work through enhanced executive attention to alleviate depressive symptoms in older adults? Researchers will compare Baduanjin with waitlist control. Participants will receive 12-week Baduanjin training (two sessions per week and 60 min per session).

Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.

The goals of the program are to help struggling fathers and father figures improve the parent-child relationship, sustain healthy marriages and relationships (and help those who are single identify ways to enter into safe and supportive relationships that may ultimately lead to marriage), and identify and support fathers in their economic stability and employment objectives. These outcomes will be achieved through a series of workshops addressing responsible parenting and marriage and relationships as well as a complement of employment services and comprehensive case management. Additional services needed by participants will be identified and provided either through wraparound programming provided by JFCS or through collaborative agreements with local partner agencies. Additionally, Ignite will incorporate a comprehensive employment program combining both job and career advancement.

Restoring Empowerment and Choosing Hope (REACH)

The goals of REACH are to help adults develop the skills they need to develop healthy relationship and marriage skills, improve ability to parent and co-parent effectively, identify and enhance skills and abilities required to gain or retain economic self-sufficiency, and foster family stability and increase successful marriage rates. Data from the tri-county region comprised of Sarasota, Manatee, and Charlotte counties demonstrates the presence of a number of risk factors affecting family stability, including high rates of single-parent households, births to unwed mothers, and high median rent costs compared to poverty rates and income. By providing families with relationship enhancement, parenting, and economic self-sufficiency services, this should help to optimize each family member's quality of life and improve child well-being.

Efficacy of an Early Rhythmic Intervention in Infancy

The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity. Specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). This intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. The efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. The efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. In addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention. The investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.

'Nurture and Play' - a Pilot Study

The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners. More specifically the objectives of the study are to: * Test the feasibility of the NnP including both parents * Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention * Evaluate the collaboration between the hospitals and the municipalities. The study consists of: 1. A randomized controlled pilot study (n=20 women/couples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers/couples. 2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention. Data will be collected through: * Online Questionnaires. * Interviews. * Videotaped settings.

Internet Delivered Therapy for Social Anxiety in Adults

The goal of this clinical trial is to learn if an internet-delivered CBT protocol for social anxiety in adults (PORTiSOFIE) is effective in Portugal. It will also learn about the impact that PORTiSOFIE may have on relationship dimensions of these individuals. The main questions it aims to answer are: Does PORTiSOFIE is effective? What impact PORTiSOFIE has in relationship dimensions? Participants will: Be assigned to experimental group and receive intervention briefly after screening is complete; Or control group and only receive intervention after the experimental group finishes.

Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention

Participants included in SCAPIS2 (Swedish Cardio Pulmonary bioimage study) are screened regarding swallowing difficulty using a timed water swallow test. Participants who show signs of swallowing difficulty (dysphagia) are included in the present study, which encompasses s flexible endoscopic evaluation of swallowing function (FEES). Participants showing a moderate-severe dysphagia are randomized into one of three intervention groups: muscle strengthening training, skill-based swallowing training and a control group who will receive compensatory treatment. The study is expected to improve diagnostics and treatment of swallowing difficulties in an ageing population.

Evaluation of Educational Interventions Targeting Beliefs About Human Papillomavirus (HPV)

The goal of this clinical trial is to compare the effects of two different educational training programs on beliefs about Human Papillomavirus (HPV) in a group of female hospital employees. The main questions it aims to answer are: • Within the scope of the study, are the training programs provided to reduce misconceptions about HPV effective? • Which educational program is more effective in reducing misconceptions about HPV? Participants will • Complete a pre-test online the day before the first training date to determine the level of their misconceptions about HPV. • Receive informative messages via Whatsapp once a day for three days according to the training program they are assigned to. • Repeat the pre-test at the end of the training programs and one month later. • Receive the more effective training program after one month after the test repetition for the control group. Researchers will compare "Misbeliefs about HPV" and "Current Knowledge about HPV" titled training programs on reducing misconceptions about HPV.