Clinical Research Directory

Talk Parenting Education Program II

The goal of this clinical trial is to learn whether Talk Parenting, a voice-based program delivered through an Amazon Echo Dot (Alexa), can help parents and caregivers of children ages 3-5 years improve challenging bedtime and morning routines. The main questions it aims to answer are: Does using Talk Parenting improve families' bedtime and morning experiences and children's sleep/wake habits? Does using Talk Parenting improve parents' routine-related parenting practices and confidence, strengthen the parent-child relationship, and reduce children's behavior problems and parents' stress? Researchers will compare families who receive Talk Parenting right away to families who wait 6 weeks to receive the program (a waitlist control group receiving usual services during the wait). Participants will: Complete online questionnaires at the start of the study and again about 6 weeks later (and a follow-up questionnaire later in the study). Receive a pre-configured Amazon Echo Dot (to keep) and instructions to use Talk Parenting routines at home, including a bedtime routine, a brief calming routine, and a morning routine (enabled after the first 2 weeks).

ResIlience-based Stigma REdUction Program ("Rise-up")

Stigma and discrimination related to HIV and AIDS ("HIV-related stigma") have been identified worldwide as major barriers to HIV treatment and care, posing challenges to HIV prevention efforts and provision of adequate care, support, and treatment. Despite decades of global efforts to tackle HIV-related stigma, previous interventions designed to reduce stigma have been largely ineffective. The knowledge gaps and challenges for combating HIV-related stigma are partly rooted in the complexity and diversity of the stigma and partly in the limitations in current conceptualization of stigma reduction efforts. Recent research, including our own preliminary data, has shown the promise of resilience approaches that focus on the development of strengths, competencies, resources, and capacities of people living with HIV (PLWH) and those of their real or surrogate family members and healthcare facilities to prevent, reduce, and mitigate the negative effects of stigma. However, the resilience approach, while hypothesized, has not been widely tested in intervention trials. In the current application, we propose to develop, implement, and evaluate a theory-guided, multilevel multimode resilience-based intervention via a stepped-wedge randomized trial among 800 PLWH and their real or surrogate family members as well as 320 healthcare providers in Guangxi, China where we have built a strong research infrastructure and community collaboration through NIH-funded research since 2004. The primary outcome will be viral suppression among PLWH, and the intermediate outcomes will include resilience resources at the levels of individuals, the real or surrogate family members, and healthcare facilities as well as chronic stress response and adherence to treatment and care. The proposed study is innovative as it addresses a number of knowledge gaps in HIV-related stigma reduction intervention research based on both a conceptualization of stigma reduction and advancement in intervention research methodology (e.g., multilevel and multi-component intervention modality, a stepped wedge design, the addition of biomarkers to assess the effects of stigma, and targeting primary HIV clinical outcomes such as viral suppression). The proposed research is significant as it addresses a critical public health issue in the US and globally. The proposed intervention protocol, if proven efficacious, has the potential to be replicated in other low- and middle-income countries to mitigate the negative impact of stigma on the HIV treatment and care continuum.

Evaluation Methodology of Emotional States for People With Cerebral Palsy

The objective of this study is to determine what are the most robust parameters for the measurement of emotional states in users suffering from cerebral palsy. Users have different ages (adults and children) with different capacities. Measures will be taken in different contexts where users will do several tasks pleasant and unpleasant. Some of the tasks involve physical activity, which must be taken into account due to the possible disturbance that it can introduce in the measures taken. It is intended to detect states of demotivation, fatigue, or physical or emotional stress. For this, we will use signals of two types: physiological measurements and inertial sensors. The handicap we find is that the subjects have difficulties expressing and recognizing emotional states, which rules out the use of a self-assessment test to contrast the measures taken. This makes us turn to their caregivers or family members or alternatively or in a complementary way to take measurements in contexts or situations of daily life where the emotional state induced in the subject is known. Once the parameters were established, the measurement of the emotional state will allow us to make a real-time evaluation of how the users are feeling during the tasks, in this way the activity can be better conducted by adapting it so that it is as efficient as possible and takes us to good results. Music will be studied as a motivating factor and for improving the emotional state when approaching rehabilitation therapies. There will be 4 sessions during which measurements will be recorded. 1: measurement of this parameter when he or she is in an activity of daily life that is pleasurable. 2: measurement of this parameter when he or she is in an activity of daily life that is of discomfort. 3: Measurement of this parameter during the performance of rehabilitation activities. 4: Measurement of this parameter during rehabilitation activities accompanied with music according to the preferences.