176 Clinical Trials for Various Conditions
The purpose of this study is to assess how family relationships are related to health and nutrition behaviors among transgender and gender diverse youth and young adults.
The purpose of this study is to investigate a behavioral intervention with foster families.
In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.
The current study aims to examine the effectiveness of an online, self-paced post-adoption intervention to improve understanding, well-being, and connection within adoptive families.To evaluate the effectiveness of this intervention, a mixed method, pre-post design with two conditions will be used. Data from standard, reliable measures and free-response items will be collected pre- and post-intervention from participants in two conditions: the intervention condition and the waitlist condition. The intervention condition involves receiving the intervention immediately following pre-assessments; the waitlist condition involves receiving the intervention approximately 3 months after the intervention condition once all data collection is completed. The study aims to answer six research questions. Each research question involves analyses of the differences between the intervention and waitlist conditions across multiple time points. 1. What is the intervention's effect on improving awareness of the needs of different family members and understanding how to meet these needs? Hypothesis 1: At post-intervention, parents in the intervention condition will report an improved awareness of the needs of each family member and greater understanding of how to meet these needs. 2. What is the intervention's effect on parent well-being (i.e., parenting confidence and parenting stress) from pre- to post-intervention? Hypothesis 2: Parents in the intervention condition will report increased parenting confidence and trending decreases in parenting stress from pre- to post-intervention compared to those in the waitlist condition. 3. What is the intervention's effect on child well-being (i.e., self-esteem and emotional and behavioral problems) from pre- to post-intervention? Hypothesis 3: Children in the intervention condition will report increased self-esteem and trending decreases in emotional and behavioral problems from pre- to post-intervention compared to those in the waitlist condition. 4. What is the intervention's effect on the quality of the parent-child relationship from pre- to post-intervention? Hypothesis 4: Both parents and children in the intervention condition will report improved connection in the parent-child relationship from pre- to post-intervention compared to those in the waitlist condition. 5. As an exploratory question, what is the intervention's effect on the quality of the sibling relationship from pre- to post-intervention? Hypothesis 5: Children in the intervention condition will report an improvement in the quality of their relationship with their sibling(s) from pre- to post-intervention compared to children in the waitlist condition. 6. What is the intervention's effect on connection and communication within the overall family system from pre- to post-intervention? Hypothesis 6: Parents and children in the intervention condition will report increased family communication and family connection in the whole family system from pre- to post-intervention compared to parents and children in the waitlist condition.
Community Health from Engagement and Environmental Renewal (CHEER) will leverage previous Centers for Disease Control and Prevention (CDC) community engagement projects to reach and intervene on a high need population. Disadvantage and poverty have long-term and transgenerational adverse impacts on social interaction and cohesion and residents' emotional and physical health. Mothers living and raising children in these conditions face multiple stressors without the community support previous generations relied on. Decades of research on American cities have connected the social, economic, and physical characteristics of neighborhoods with a lack of social cohesion, inability to maintain shared norms of acceptable behavior,and increases in health disparities and risky behaviors. Social cohesion and collective efficacy inversely associate with depression among youth. In a parallel manner, improved parenting practices and youth behavior directly associate with neighborhood social interactions and social cohesion. While these associations are suggestive, CHEER will directly test causal hypotheses at the neighborhood and family levels in a randomized control trial, that can significantly advance the evidence base for public health interventions: Family Youth Intervention (FYI) and an Environment: Social and Physical Intervention (ESPI) to increase social interaction, social cohesion, and collective efficacy and influence wellbeing of mothers and their youth.
The goal of this study is to pilot an adapted family resilience program among families with a recent history of homelessness in Los Angeles County and to assess for feasibility and acceptability. The investigators have adapted a family resilience program called Families Overcoming Under Stress (FOCUS), a trauma-informed intervention designed for families experiencing trauma, parental substance use, and homelessness. Our primary hypothesis is that the adapted family resilience program will be feasible and acceptable to families with a recent history of homelessness. Families that are eligible to participate in the study will be assigned to the adapted family resilience intervention. The intervention program consists of around 8-10 modules lasting up to one hour each. The program provides psychoeducation and teaches resilience skills including communication, problem solving, goal setting, and how to deal with stress. Families will be asked to fill out 3 surveys (one at the beginning of the program, one at the end of the program, and at 6 months follow-up). Some families may also be asked to participate in a hour long interview after the completion of the program for feedback on the program. At this time, all assessments and intervention are being conducted remotely due to the pandemic.
The purpose of this study is to determine whether the healthy marriage and relationship education program Elevate: Taking Your Relationship to the Next Level results in improved couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect potential.
This project evaluates Real Relationships, a program provided by the Children's Aid Society (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible Fatherhood) program. Research questions focus on recruitment and retention of participants, and short- and long-term participant outcomes associated with different formats for offering the program.
The Parenting Center (TPC) offers the Empowering Families program, which integrates a relationship education curriculum (Family Wellness) into a comprehensive set of services that includes case management, employment services, and financial coaching. The evaluation will test the effectiveness of offering relationship skills education services with a robust economic security component to low-income couples raising children.
The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.
Every program element was designed to ensure that all children in the areas served will live in stable, happy, healthy family situations. The JFCS Healthy Families/Healthy Children program will provide relationship skill enhancement interventions. All program participants in the intervention group will have acces to: parenting skill enhancement interventions, employment readiness and/or situation enhancement, as well as financial knowledge and/or situation enhancement.
The University of Florida offers relationship education programs named ELEVATE, for couples, and Smart Steps, for couples in stepfamilies, in Citrus, Duval, Manatee, Palm Beach, and Santa Rosa counties. Each workshop comprises 4 2.5-hour long sessions. The STREAMS evaluation will examine whether text messages informed by behavioral insight theory can improve couples' attendance at relationship skills education group sessions, and if so, which kinds of messages are most effective
Research shows that sexual and gender minority youth (SGMY) experience high rates of mental health problems and other challenges (e.g., social, academic). A major factor that leads to these challenges is family rejection (family behaviors and reactions that minimize, deny, ridicule and attempt to prevent or change a child's sexual orientation, gender identity and gender expression). Racial and ethnic minority youth experience the highest rates of family rejection and related health risks. The Family Acceptance Project (FAP) is a research, education, and intervention initiative that was founded more than 20 years ago to help diverse families learn to support and affirm their SGMY. FAP's Family Support Model is grounded in the lived experiences of diverse SGMY and families and uses a culture-based family support framework that enables parents and caregivers to change rejecting behaviors that FAP's research has shown contribute to health risks and increase supportive and accepting behaviors that promote well-being for SGMY. The overall goal of this research project is to evaluate a nine-week online version of FAP's Family Support Model (FAP-O). The investigators will specifically study how FAP-O: 1. Promotes parent/caregiver acceptance and support of their sexual and gender minority youth. 2. Increases family bonding and communication. 3. Increases SGMYs' feelings of pride in being LGBTQ+ and more hopeful about the future. 4. Leads to reductions in mental health problems reported by SGMY who experience family rejection. Before receiving FAP-O's family support services, racial and ethnic minority SGMY (ages 14 to 20) and their caregivers will complete an initial pre-test survey. After completing this initial (baseline) survey, half of the families will participate in program sessions. Following the first round of sessions, all participants will complete an immediate follow-up survey, with an additional survey conducted six months after this. These surveys help us learn if FAP-O impacts the project's goals above. After the final survey, the other half of the families will attend program sessions. The investigators will also ask SGMY and caregivers to share what they liked about the program and their guidance for enhancing it.
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).
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.
The goal of this clinical study is to develop a community-based program to support family members of transition-aged youth on the autism spectrum to help them plan for the future. The main aims of the study are: 1. To develop the Families FORWARD program 2. To conduct proof-of-concept testing of the Families FORWARD program Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program.
The goal of this study is to determine the feasibility and acceptability of a novel family-based hypertension self-management intervention, Walk Together, adapted from an existing empirically-supported dyadic intervention, for implementation in primary care.
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.
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.
The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?
Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope program to promote responsible fatherhood in the Bronx among low-income adult (18 years or older) fathers with non-custodial children (under the age of 24). The program, called HERO Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by enhancing relationship and anger-management skills and providing marriage education; providing skills-based parenting education, disseminating information about good parenting practices, and encouraging child support payments (in partnership with our local OCSE); and fostering economic stability by providing employment-related supports inclusive of job search, vocational skills training, job referrals, and job retention.
The purpose of this project is to test the impact of different forms of technology (virtual reality vs. video chat) on quality of life and family relationships in older adults who reside in senior living communities and an adult child who lives at a distance. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.
The project is aimed at meeting the support needs of community fathers who are expecting a baby or who have recently had a baby. This work is being conducted in conjunction with community partners through The Women's Clinic of Northern Colorado (WCNC). Researchers and WCNC staff will work together to develop and implement programs for prenatal and postpartum fathers. Participants will be invited to a group mentoring program and also will be provided access to supplementary educational podcasts focused on topics relevant to prenatal and postpartum fathers. The investigators are seeking to understand what participants like and don't like about the program and how participation in the program affects participants' stress, well-being, and parenting.
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.
The proposed study will evaluate the efficacy of a family-based obesity prevention intervention in increasing physical activity and improving the quality of dietary intake among Hispanic Youth. Additional primary outcomes that will be examined include drug use and sexual risk behaviors. Secondary outcomes include examining the effects of family functioning and BMI. The knowledge expected to be gained in this study will have strong implications for prevention as well as contribute to the reduction of obesity-related health disparities seen in Hispanic youth.
The smart phone application (B-SMART) to be developed in this research project for family members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid drunk driving once the IID is removed from their automobiles. As such, the public health consequences of DWI, in terms of health, morbidity and mortality, and its economic and societal consequences, will be positively influenced by a highly accessible and diffusible intervention. The proposed Phase II project will complete the development and programming of the B-SMART smartphone web app and test its impact in a randomized efficacy trial with first-time DWI offenders and their concerned family members.
This study is designed to refine and test the efficacy of a computer assisted culturally informed and flexible/adaptive intervention for Latino adolescents for whom self-harm behaviors are a health disparity-specifically, Latinas and sexual/gender minority youth.
The proposed program will flexibly provide an array of relationship promotion activities incorporating case management and job placement/career advancement activities: marriage and relationship education; pre-marital education and marriage skills; marriage enhancement and marriage skills for married couples; and divorce reduction and relationship skills. In addition, our proposed local evaluation will examine factors that might account for the observed impacts of attending relationship education programs (i.e., higher levels of relationship satisfaction), including dosage of workshops, relationship commitment and longevity, and skill learning.
This pilot study will test the effect of an online asynchronous psychoeducational intervention to improve relationship quality and prevent verbal-type elder mistreatment in caregiving dyads. The investigators will use a pre-post test design to test the feasibility and acceptability of this video-based intervention, and to determine the likelihood that participation in this program may improve caregiver relationship quality.
This study will develop and test the efficacy of an online, family-based intervention (MySTYLE) tailored to the relevant sexual health needs of non-heterosexual adolescent males and their parents/caregivers compared waitlist control group. Adolescent males and their parents will be recruited from community organizations, medical clinics and schools in Jackson, MS. Interviews with youth, parents, and relevant community leaders will inform the development of the interventions. Youth and their parents/caregivers in both intervention arms will complete three assessments in the four months after enrolling. This study will provide a wealth of information about the degree to which this intervention may be disseminated for this highly vulnerable population of young people.