Clinical Research Directory

Jockey Club Support Project

Guided by the process model of emotion regulation, integrative affect-regulation framework for resilience, and the reciprocal dynamics of emotion, affect, and resilience in the family system, researchers will develop a parallel intervention to incorporate two key members in Mainland-Hong Kong cross-boundary families: a parent and a child by improving their affect/emotion regulation skills, de-escalate family conflicts, and flourish under hardships. Specifically, researchers predict that participants in the intervention group will report greater improvement in resilience, emotion regulation, psychological well-being, family harmony, and social connectedness than those in the control group.

Evaluation of a Family-centered Program for Problematic Gaming/Excessive Screen Use

The Family-Centered Program for Problematic Gaming and Excessive Screen Use (FAME) is a pioneering initiative designed to address the growing challenges of excessive screen use and gaming among children and adolescents, particularly within family dynamics.

Transitioning Together Boston

A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time.

Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families

The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions.

Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration

Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders. As described above, three high risk groups are interested in this study, the previous heavy smokers (group 1); those who has family history (group 2) and those who have high risk occupation or environment factors (group 3). From the published researches, we assume the detection rate to be 1.1% for group 1 based on NLST results16, 2.6% for group 2 (395 out of 12,011 subjects in TALENT), and we assume the detection Group 3 to be 1% after consulting board-certified senior specialists in this field. This is a prospective, multi-center, single arm study in Taiwan of subjects who are eligible to receive LDCT screening based on recommendation of Health Promotion Administration of Taiwan. The primary objective of TRIO part A is the LDCT screening acceptance rate of high lung cancer risk subjects. The primary objective of TRIO part B is the exact lung cancer detection rates in these three groups. Other secondary objectives are also included.

Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa

The study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths.

Specimen and Clinical Data Collection Plan for LDCT Screening Participants

Lung cancer remains the leading cause of cancer-related mortality in Taiwan and globally, with increasing incidence and the highest healthcare cost burden among cancers in Taiwan. Despite the widespread use of low-dose computed tomography (LDCT) for screening smokers, over half of lung cancer cases in Taiwan occur in never-smokers, highlighting the need for improved risk stratification. Current national LDCT screening programs do not collect comprehensive risk-related data, limiting their predictive accuracy. This project proposes a five-year, multi-center initiative to establish an integrated biospecimen and clinical data collection system. In its first year, a feasibility pilot will be conducted, followed by recruitment of 12,000 participants. Data collection will include biospecimens (blood, urine, tissue), genomic and proteomic analyses, imaging, and detailed questionnaires covering lifestyle, environmental, and occupational exposures. The project will also develop and validate lung cancer prediction models incorporating epidemiologic, biomarker, air pollution, and imaging data. A Common Data Model (CDM) will be implemented to ensure cross-institutional data standardization and support future international collaboration.

Family Intervention for Black Teens With Type 1 Diabetes

The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).

Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings ("sibling participants;" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT. Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment. Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol. Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.

Filipino Family Health Initiative

The overall objective of this research is to test the effectiveness of a parenting program on Filipino parents living in California. The sample will include 180 Filipino immigrant families, half of which will receive the Online Incredible Years® School Age Basic \& Advanced Parent Training Program (intervention) and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control) and be placed on a 3-month waitlist for the IY parenting program.

Parent Web - Support for Families With Young People

To test an online parent training program. Relative to a randomized wait-list control group, those in the Parent Web (PW) will show benefits on well-being, parenting, stress, youth mental health.

The Parental Journey. Digital Tool for Security in Parenthood, a Way to Promote Public Health. A Pilot Study.

The goal of this randomized clinical pilot study is to evaluate the feasibility and experience of the internet-based parental support program "Parenting - a journey together". This program is intended to be delivered via the national Support and Treatment Platform and used within primary care to enhance traditional parental support within child health care when needed. The main questions it aims to answer are: 1. Is the digital parental support intervention feasible and helpful within primary care? 2. How do parents perceive the program "Parenting - a journey together"? 3. Does the program increase the sense of parental ability and security in parenting by reflecting on attitudes and approaches in interaction with the child? Participants in this study will be parents of children aged 2-5 years who have expressed interest in participating in the study and in the parental support program. Participants will be randomized into either the intervention group or the control group. Participants will be asked to complete validated questionnaires measuring the parent-child relationship, perceived parental ability, stress, and well-being before and after the parental support program, and again after 3 months. These results will then be compared with those of the control group.The knowledge gained from the pilot study can contribute to the development of digital parental support interventions within primary care. If the pilot study proves that the interactive digital parenting program is feasible for use in child health centers and is perceived as helpful by parents, a larger randomized controlled (RCT) study, (not included in this application) will be conducted to evaluate its effectiveness.

Dialogical Family Guidance PostDoc Study

This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention.