Clinical Research Directory

Mixed Methods Evaluation of the Pomona Household Universal Grant (HUG) Program

The City of Pomona is launching the Pomona Household Universal Grant (HUG) program in the Summer of 2024. Pomona HUG is a pilot project that will provide 250 parents/caregivers with children under 5 years old $500 a month for 18 months. Pomona's guaranteed income (GI) initiative provides relief for the most economically vulnerable households. The study will investigate the impacts of GI on financial security, material hardship, health and well-being, food security, social support, parenting, and childhood development. The intervention group will be compared to a control group of 350 parents/caregivers receiving only a nominal ($20) amount per month during the 18 month period.

The Effect of Short Film and Video-Based Education on the Intensive Care Unit Introduction for Parents of Premature Infants on Stress, Care Participation, and Satisfaction Levels

The primary objective of this single-center, parallel-group, randomized controlled experimental study is to evaluate the effect of short film and video-based education on the intensive care unit orientation provided to parents of premature infants, specifically assessing its impact on stress levels as the primary outcome and satisfaction and level of involvement in care as secondary outcomes. Using the block randomization method, 72 parents will be assigned to three different groups ("Routine Care" n=24, "Routine Care + Short Film-based Education" n=24, "Routine Care + Video-based Education" n=24). Research Hypotheses: Primary Hypothesis: H1/1: There is a difference between the mean stress scores of parents by group. Secondary Hypotheses: H1/2: There is a difference between the mean scores of parents' participation in care according to groups. H1/3: There is a difference between the mean scores of parents' satisfaction according to groups.

Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties

The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems. The main questions this study aims to answer are: * Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention? * Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)? Researchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention. Participants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old. If assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.

Project COPE-Spain (Coping Options for Parent Empowerment)

The goal of this study trial is to establish the preliminary clinical utility of the COPE program (Coping Options for Parent Empowerment) adapted for caregivers of adolescents in the Spanish context. This program aims to improve parents' emotional well-being, enhance their parenting skills, and promote positive changes in their childrens' emotional and behavioral well-being. This study will adapt the COPE program for in-person group administration in the Spanish context, specifically in the school setting.

Enhancing Preschool Children's Attention and Behaviour: Parent-Focused Program

This study aims to evaluate the feasibility and efficacy of the Building Regulation in Dual Generations (BRIDGE) program for caregivers with significant mental health concerns and preschool and young children (3-7 years old) with elevated attention and/or behavior problems. The BRIDGE program focuses on supporting parental psychological distress and improving young children's self-regulation (SR), thereby reducing their attention and behavior problems. The long-term goal of this work is to improve family well-being and social-emotional development for young children by implementing an accessible and scalable dual-regulation program. The investigators will achieve this through the following key objectives: 1. Assess the feasibility and accessibility of BRIDGE for preschool and young children (3-7 years old) with significant attention and behavior programs through questionnaires asking about attendance, satisfaction, and unmet needs. 2. Examine the efficacy of BRIDGE compared to control group at improving maternal mental health and child attention and behavioral difficulties in young children (primary outcomes). The investigators will also examine parenting stress (secondary outcome). 3. Identify predictors of academic readiness skills in preschool and young children. The investigators hypothesize that an increase in parental and child emotion-regulation skills and reduced attention, as well as behavioral problems, will lead to increased pre-academic skills in children.

Mother-infant Bonding in the Brain: a Mindfulness-based Intervention

The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or parental stress. The intervention "Mindful with your Baby" is one of the very few interventions for maternal postnatal mental health issues that takes the bond between mother and infant into account. It is hypothesized that the "Mindful with your Baby" intervention will reduce levels of postpartum depression, anxiety and parental stress, and improve mother-infant behavioral interaction and increase neural synchrony between mother and infant brains.

The Effect of a Micro-Appreciation Intervention (Three-Things Journal Application) on Caregiver Burden, Family Functioning, and Happiness Levels for Mothers of Children With Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder in which individuals experience significant difficulties in social interaction, communication, and repetitive behaviors. Families of children with ASD, especially mothers, face a high level of physical, emotional, and psychological caregiving burden while trying to adapt to their children's developmental needs. Constant caregiving responsibilities increase the risk of burnout, stress, and depression in mothers, while also negatively impacting family functioning and life satisfaction. Mothers of children with ASD require greater emotional resilience, self-regulation, and social support than those in traditional parenting roles. In this context, interventions that support psychological well-being offer important strategies that can help mothers cope with the burden of care. In recent years, positive psychology-based interventions have been shown to positively contribute to individuals' mental health and are effective in increasing subjective well-being. Positive psychology approaches help individuals recognize and focus on the positive aspects of their lives, reducing stress levels and increasing psychological resilience. One such approach, micro-appreciation interventions, aims to increase individuals' positive emotional experiences by consciously focusing on small but significant positive events they encounter in their daily lives. Micro-appreciation interventions change individuals' perceptual frameworks, encouraging them to focus on positive moments instead of negative experiences. Such interventions stand out as an effective method for reducing the psychological and physiological effects of stress, increasing positive emotions, and improving overall life satisfaction. One micro-appreciation intervention, the "Three Things Journal," is a simple yet effective strategy that involves individuals writing down three positive events they appreciate in their lives each day. Research has shown that this practice is effective in increasing individuals' awareness of positive experiences, reducing levels of depression and anxiety, and increasing subjective well-being. Regularly experiencing positive emotions strengthens individuals' ability to cope with challenges and increases their psychological resilience and optimism. Especially for individuals under intense stress, such small but regular practices can yield greater psychological benefits in the long term.

Acceptance and Commitment Therapy-based Intervention for Parents of a Child With Medical Complexity

A pilot randomized controlled trial of an Acceptance and Commitment Therapy-based intervention will be conducted to decrease psychological symptoms, while increase psychological flexibility for parents of a child with medical complexity during their difficulties.