54 Clinical Trials for Various Conditions
The purpose of this descriptive study is to explore whether there is an association between participation in the Strong Fathers, Stronger Families program and improvements in outcomes related to parenting, co-parenting, and economic stability. Participants are surveyed at program entry and program exit, and changes in participant attitudes are assessed over time.
Based on findings from our prior trials with parents of children with learning and attentional disabilities and parents of children with autism spectrum disorder (Kuhlthau et al., 2020; Park et al., 2020; IRB approved: #:2016P001622 and 2016P002037 respectively), the investigators propose to pilot test and refine the adapted resiliency intervention (SMART-3RP) among fathers of children with special health care needs.
Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.
The purpose of this study is to examine the feasibility of implementing a mental health intervention, using individual and group Cognitive Behavior Therapy (CBT), embedded into Fathers for a Lifetime; an existing parenting program for fathers. The study will also assess the mental health status and daily functioning of fathers participating in the intervention and comparison arms. The mental health treatments available for parents focused on prevention and treatment of mothers or families but rarely was there a focus on fathers. Our study will use an existing parenting program for fathers to provide a mental health treatment for African American fathers with the intent of creating an effective treatment to screen, diagnosis, increase access to mental health services, and provide mental health treatment. By improving fathers' mental health, we can expect to see improvement in daily functioning, parent-parent interactions, parent-child interactions, increase confidence in parenting skills, and a decrease in parental stress.
This pilot study evaluates the feasibility and impact of a father-focused childhood obesity prevention program on paternal food-related parenting practices, mealtime behaviors and father/child nutrition and physical activity behaviors. Half of participants (low-income father and child dyads) will receive an intervention immediately while the other half of participants will serve as a wait-list control group and receive the intervention at a later date.
The purpose of this study is to determine the efficacy of Family Foundations that is to be delivered concurrently with home visiting. Delivered prenatally and postnatally, Family Foundations is a coparenting prevention program for new mothers and fathers that is designed to optimize child outcomes by teaching parents how to work together in raising their child. Using a randomized clinical trial design, families will be assigned to receive Family Foundations + home visiting or home visiting alone. A comprehensive assessment is administered at baseline and then at post-intervention, and 9 and 18 months later. It is hypothesized that families receiving Family Foundations will improve in their resolving of conflict from pre-intervention through follow-up. Additional anticipated outcomes are that those receiving the intervention will have more involved fathers, mothers and fathers will report less conflict, and children will have better emotional and behavioral outcomes relative to those who receive home visiting alone.
This study focuses on the development of the Fathers Supporting Success in Preschoolers (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading to engage fathers in and improve parenting and child behavior.
This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies. Our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU. Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.
This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.
The goal of this observational study is to assess the American Psychological Association's ACT Raising Safe Kids program with male caregivers. The main question\[s\] it aims to answer are: • Will male caregivers in the ACT Raising Safe Kids program report lower child maltreatment, rates of interpersonal violence, and youth aggression. • Does the ACT RSK program have a positive return on investment and will children and caregivers in the ACT RSK condition have a higher quality adjusted life years. Participants will complete four surveys over time and attend the 9-week ACT Raising Safe Kids program. Researchers will compare survey responses from male caregivers taking the ACT Raising Safe Kids classes to male caregivers not taking ACT Raising Safe Kids classes to see if there are changes in anger regulation, family conflict, parent-child conflict, and relationship satisfaction.
The goal of this clinical trial is to test the efficacy of Fathers for Change (F4C) compared to standard Batterer Intervention for fathers with a history of Intimate Partner Violence. The main question\[s\] it aims to answer are: 1. Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment? 2. What are the trajectories of therapeutic change targets across interventions? 3. Does father's emotion regulation and reflective functioning mediate the relationship between the two interventions and child-related outcomes? Participants will be randomized to either Fathers for Change on Batterer Intervention.
Young families need additional institutional support to help them meet the challenges of parenthood. Prenatal clinics are well situated to address some of their needs by expanding services to include fathers. The Father Inclusive Prenatal Care (FIPC) model is designed to prepare young men for the challenges of parenting by supporting the development of their relationship skills as part of routine prenatal healthcare. This approach involves assessing expectant fathers and mothers with a "parent prep-check" (PPC) to identify their needs and then offer services to address those needs and prepare them for parenthood. Services include: (1) parent education about how to understand and care for infants, and how to build secure parent-child bonds; (2) an evidence-based co-parenting program to strengthen and stabilize their family; and (3) educational and employment support designed to help young parents find and keep living wage jobs. The project will be implemented through several community based healthcare sites that are well positioned to engage young fathers through their prenatal clinics. To extend the reach and accessibility of the model, trainings and most services will be available online. As a result of participating in this project it is expected that young couples will have better co-parenting relationships and be better prepared to take care of their infants.
Fathers play a unique role in the lives of children, with high quality interactions found to improve a child's executive functioning and general school achievement. Father involvement also has positive impacts on fathers themselves, with more involved fathers reporting more self-confidence in their parenting, more satisfaction with parenting, demonstration of more maturity, and reports of less psychosocial distress. However, poverty can have a negative association with fathers parenting and child outcomes, though paternal warmth can mediate this relationship. Children's Institute Inc will recruit and implement the 24/7 Dad program which is designed to provide a comprehensive evidenced-based fatherhood program that builds and strengthens father-child relationships. The curriculum for the primary workshops will be the 24/7 Dad curriculum, which addresses both the responsible parenting and healthy relationship areas in this project. A quasi-experimental interrupted time series (ITS) design allows for a continuous sequence of observations on a population, taken repeatedly over time.
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 First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations. This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.
This is a single-arm pilot study to evaluate the feasibility and acceptability of a novel psychosocial intervention to improve psychosocial outcomes for parents with advanced cancer and their co-parents. In this single-center study, we will recruit ten mothers with metastatic breast cancer and their co-parents as dyads (N=20) to participate in the Fathers and Mothers Invested in the Lives of their Youth (FAMILY) intervention. Patient and co-parent dyads will participate in 2-3 study visits with an intervention facilitator and a post-intervention feedback interview. Participants will also complete baseline and follow-up study surveys. The final products of this study will be the FAMILY intervention manual and training materials, and fidelity assessments.
This feasibility and acceptability study will compare in-person to web-based parenting education for adolescent fathers on the outcomes of parenting confidence and participation in parenting activities.
The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance related behaviors and weight status.
While existing teen pregnancy prevention efforts have contributed to significant declines in the overall U.S. teen pregnancy rate, teen pregnancy prevention programs specifically targeting adolescent males are limited and sorely needed. The primary aim of the proposed research is to further develop, evaluate, and disseminate a teen pregnancy prevention program specifically designed for adolescent males to enhance the current scientific evidence and intervention options available for broad public health implementation. The proposed intervention Fathers Raising Responsible Men (FRRM) focuses on the adolescent male component of teen pregnancy by identifying and addressing adolescent risk and paternal protective behaviors specific to adolescent males that have not been fully addressed in previous prevention efforts. This study strives to reduce adolescent male sexual risk behavior through targeting African American and Latino adolescent males aged 15-19 and their fathers residing in the South Bronx, specifically Mott Haven and surrounding areas in three phases. Phase I is a pilot study consisting of eight dyads (fathers and sons) to test and refine the intervention and technical and training assistance needs. Phase II is the Randomized Control Trial (RCT) comprised of two cohorts (a total of 500 father-son dyads) to rigorously evaluate the intervention. During the final 6 months of the project, qualitative interviews with 30 father-son dyads will be conducted to triangulate the quantitative RCT results with participant experiences of FRRM. Finally, in Phase III the intervention will be refined and the intervention materials will be available to the general public, while findings will be widely disseminated. These three phases allow for the successful implementation and evaluation of FRRM in conjunction with the refinement and provision of all training and technical assistance necessary for the intervention. If successful, the proposed project will further develop the current scientific evidence and intervention options targeted specifically to the teen pregnancy prevention needs of African American and Latino adolescent males.
During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for home visiting clients. Focus groups with prior study participants, their male partners, and home visiting staff will be used to develop the FAB curriculum and protocol. FAB text messages aim to improve the mental health of the male partner and help him support his partner's mental health. Feasibility, acceptability, and outcome measures will be supplemented with assessments of fathers' mental health and partners' relationships. Participant assessments will be conducted at baseline, 3 and 6 months in this uncontrolled pilot study. The public health significance and innovation of this project is substantial. If the investigators are able to integrate MB-TXT and MB-DAD into home visiting programs and generate improved mental health outcomes for home visiting clients and their partners, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visitation as a service delivery model for families with infants and young children is rapidly proliferating through federal funding.
The Fathers' Support Center, in partnership with the Brown School Evaluation Center at Washington University in St. Louis, seeks to evaluate the impact of their New Pathways to Responsible Fatherhood Family Formation Program (NPFF). The investigators are most interested in quantifying the added benefit of parenting, father-child engagement, and father well-being curriculum compared to course content containing 80 hour economic stability material only. The impact evaluation will answer four key outcome and implementation specific questions using a mixed methods approach. Participants will be randomly assigned to one of two groups (full program or 80 hour economic stability curriculum only) and tracked for the duration of the program. The impact evaluation tools include a set of validated instruments and will be administered to participants at baseline and again at three and twelve months after completion of the program. Performance measurement data will also be included in our analysis. Investigators hypothesize that participation in the full program will have a greater effect on key outcomes than the economic stability curriculum, a similar number of families will be reached by each condition, and that there will be minimal variability in retention rates across groups.
Background: X-linked retinoschisis (XLRS) is a genetic condition. It usually presents in boys in childhood with vision loss. Genetic conditions affect the people who have it and also their family members. Researchers want to learn if mothers and fathers react differently when a son gets XLRS. They also want to learn how personality impacts the way people react. This will help researchers find better ways to support families living with XLRS. Objective: To learn more about the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS. Also to study personality differences between mothers and fathers. Eligibility: Parents of a biological son of any age with XLRS who is enrolled in protocol 03-EI-0033 Design: Participants will be asked questions in person or by phone. This will last 30 90 minutes. They will be asked about their experience with XLRS and how it has impacted their family. The interview will be recorded. Participants will complete a survey about personality traits. It will be anonymous. It can be completed by mail, email, or fax. It will take about 15 minutes. Participants data may be shared with others, including those not at NIH, if they agree. Their data may be stored. Sponsoring Institution: National Eye Institute
The Urban Institute-a nonprofit, nonpartisan research organization-is partnering with Rubicon Programs to conduct a rigorous evaluation of its Fathers Advancing Communities Together (FACT) program. FACT is a multi-faceted program designed to deliver responsible parenting, healthy relationships, and economic stability services on a voluntary basis to low-income fathers in Contra Costa County, California. Urban's evaluation comprised of three key components: The implementation evaluation will describe FACT program activities and services, including communication and coordination across partners, service delivery mechanisms, and whether and how participants and their families received comprehensive services. Urban will identify a logic model for the program and assess the barriers to and facilitators of program performance. The implementation evaluation will draw from interviews with program staff, partners, and stakeholders, as well as field observations, program and administrative data, and focus groups with FACT participants and their families. The outcome evaluation will build on the implementation evaluation to determine whether specific program components, their frequency, and their duration, are related to outcomes. Urban will conduct surveys of program participants at the time of their enrollment into the program and one year following their enrollment to explore how participants' self-reported attitudes on various domains are associated with economic self-sufficiency and family functioning. Urban will also use program and administrative data collected by Rubicon and its partners, specifically Rubicon's case management database, to assess participant outcomes. The impact evaluation will assess to what extent participation in the FACT program is associated with improved outcomes as compared to similarly situated individuals who did not participate in the program. Urban will work with Rubicon's partners to identify individuals living in Contra Costa County who were eligible to participate in the program but, for whatever reason, did not do so. Once a comparison group of fathers has been established, Urban will use individual-level outcome data to determine whether the FACT program has an impact on economic self-sufficiency and family functioning.
With an emphasis on 12 3-hour group workshops, the TRUE Dads fatherhood intervention program focuses on establishing or strengthening three of men's key roles in the family: 1) their role as providers, through fostering employment and economic self-sufficiency, 2) their role as fathers, in building and maintaining positive engagement with their children, and 3) their role in having and keeping a positive relationship with their co-parenting partner (wife, intimate partner, or other co-parent). The study is a randomized clinical trial that compares participants in a program track with participants a study track (no treatment control group) over a one-year period.
The purpose of this study is to develop and pilot test recruitment methods for a future study of prevention of sexually transmitted infections (STI), including the human immunodeficiency virus (HIV), among Black adolescent boys through sexual health education by their fathers.
In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of paternal ADHD in families and children with ADHD symptoms has not been studied, despite the prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on treatment on the family and child, and effects of treating fathers relative to mothers with ADHD. Paternal ADHD is associated with negative parenting and child conduct problems. The investigators hypothesize that successfully treating parental ADHD in fathers will have a beneficial effects on the family that will extend to the child. Specifically, the investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who have children between the ages of 3 -8. As in the investigator's previous work, the investigators will bank paternal and child DNA and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of stimulant response.
Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV) (defined as physical aggression and/or psychological abuse and control at the hands of an intimate partner), or maltreat their children there has been little consideration of the need for interventions for fathers with histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8 million children are witness to violence in their homes each year. National and regional samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance abuse have children under the age of seven. Large percentages of these men continue to live with or have consistent contact with their young children despite aggression and substance use. Court mandated treatments for perpetrators of domestic violence have become the norm, however the efficacy of these treatments is questionable and most do not speak to the broader needs of batterers and their families. How batterer's treatments might impact parenting and father-child relationships and the psychosocial functioning of children is vastly understudied and not currently understood. Since batterer treatments are court mandated and require tremendous financial and community resources, the efficacy of these interventions in stopping the cycle of domestic violence and improving the health and well-being of the batterer, his partner and children is crucial. There are currently NO evidence-based treatments that address co-morbid substance abuse and domestic violence perpetration with emphasis on paternal parenting and the father-child relationship. Consequently, the proposed psychotherapy development project will develop and evaluate the potential efficacy of a novel, relational parent intervention for fathers with co-morbid substance abuse and IPV who have young children. The goals of this intervention are to decrease aggression and substance abuse by increasing focus on fathering and an improved father-child relationship.
Smoking among Latino males living in the U.S. is a significant public health problem, one that can contribute to disparities in life expectancy and increase mortality. Latinos smoke at the same rate as White males but are less likely than Whites to quit. Interventions do not reach Latino smokers because many speak only Spanish and previous interventions have had notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers likely did not participate. Second, cessation effects were short-term only. Third, no program has attempted to boost Latino cessation rates by capitalizing on a "teachable moment", a time when quitting may seem especially relevant. To address these deficits, we propose to conduct a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We will include couples, rather than just men, to sustain intervention effects. We will partner with community leaders to develop an intervention based primarily on Social Cognitive Theory, the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements will be at the individual level to help Latinos quit smoking and others will be couple-based to improve communication and reduce stress in the postpartum relationship. The program will be culturally sensitive to Latino values, such as familismo, valuing of and duty to the family and personalismo, valuing warm personal relationships. We will recruit Latino couples (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking cessation guide, and a couple-based smoking cessation counseling arm. Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months post-randomization than Latino expectant fathers who receive a self-help smoking cessation guide. Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion, and self-image, which in turn, will increase cessation rates among Latino expectant fathers. Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than couples in the Guia arm.
Teenagers who become parents often struggle with new challenges as they try to take care of their children and themselves. Programs that provide teens with support, education, and counseling may help teens to become the best parents they can be and reach their own goals. Health care providers who take care of pregnant and parenting teenagers are trying to find out what types of programs are most helpful for the physical, emotional, and social health of pregnant and parenting teenagers. The purpose of this study is to find out what kinds of activities help teens be successful as parents and achieve success in their lives.
The purpose of this descriptive study is to explore whether there is an association between participation in the Gentle Warriors Academy and improvements in outcomes related to parenting, co-parenting, and parental well-being. Participants are surveyed at program entry, program exit, and 12 months following program enrollment, and changes in participant attitudes and behaviors are assessed over time.