61 Clinical Trials for Various Conditions
The goal of this observational study is to evaluate the effects of Pathways to Potential (P2P) on youth violence involvement in Michigan public K-12 students. The main goals of this study are: * This project will link longitudinal P2P participation data to state administrative records and school disciplinary data to evaluate associations between school P2P participation and youth outcomes-specifically chronic absenteeism, peer aggression expulsions, and child maltreatment rates within a school (Aim 1). * Given the focus of P2P is to improve the social and structural conditions within a school that contribute to student chronic absenteeism, the team will assess if chronic absenteeism rates mediate the relationships between school P2P participation and youth violence involvement (Aim 2). * Finally, a survey of success coaches will inform the examination of school and implementation factors that moderate associations between P2P participation and youth violence involvement (Aim 3). Schools participating in P2P receive Michigan Department of Health and Human Services (MDHHS) caseworkers, called success coaches, in local elementary, middle, and high schools. After identifying a social or material need that is a barrier to school attendance (e.g., transportation barriers, caregiver unemployment), success coaches connect students and families to community resources and public assistance.
Child maltreatment and child exposure to adult intimate partner violence (IPV) often co-occur and are detrimental to the mental and physical health of children, yet few prevention programs address these intersecting forms of adversity using dual-generation approaches. The proposed study is a rigorous randomized controlled trial that uses a 2x2 factorial design to evaluate the potential synergistic benefits of delivering programming prenatally and during early childhood in order to support the mother-child relationship and ultimately prevent child maltreatment. If effective in preventing child maltreatment, these programs have the potential for high public health impact given that they are both cost-effective and readily scalable.
Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM). The investigators hypothesize that: 1. The brief video-based intervention will have the immediate and repeated effect of reducing self-stigma among CM survivors compared with the control condition. 2. The brief video-based intervention will increase seeking treatment compared with the control condition. 3. The brief video-based intervention will show similar effects in reducing self-stigma across multiple countries.
Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM). The aim of the proposed study is twofold: (1) to evaluate the effectiveness of a brief video-based intervention in reducing self-stigma among individuals who experienced childhood abuse and/or maltreatment, and (2) to increase openness to seeking treatment.
This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.
This randomized trial will test a newly developed intervention aimed at fathers who have a history of family violence compared to a standard batterer intervention program.
The co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large. The need for effective dual treatment of caregiver substance abuse and child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies with substance-using parents who have engaged in child maltreatment. This project examines two evidence-based treatments-Contingency Management for substance-use problems and Pathways Triple P parenting intervention to improve parenting for prevention of child-maltreatment recurrence. These two systematic interventions are being tested in the context of traditional outpatient treatment for substance-use problems.
In child welfare services, structured behavioral parenting programs have been documented to reduce important child-welfare outcomes, including child maltreatment recidivism.1-3 In this study, we attempt to learn which factors impacted implementation of an evidence-based practice (EBP) in a diversity of child-welfare serving sites and systems. The primary aim of this study was to identify and assess barriers and facilitators of implementation of a structured behavioral parenting program (SC). We utilized a qualitative research strategy that included semi-structured interviews and focus groups with several levels of staff responsible for implementing the model: program administrators, supervisors, and frontline staff (providers). Our second aim was to understand parent and provider reactions to SafeCare (SC) services and Supportive Case Management (SCM), especially parents' perceptions related to trajectory of burden, engagement, satisfaction, and perceived impact across intervention receipt. We employed mixed methods (both quantitative and qualitative data collection) to inform this question. Specifically, we (1) conducted qualitative interviews with families at two time points during the course of service, (2) collected session-by-session ratings from families on service reaction (perceived burden satisfaction, perceived effectiveness) and providers on family engagement, and (3) collected organizational environment surveys from providers at two time points. The final aim of this study wass to examine the short-term impact of SC versus SCM on client-centered outcomes. Quantitative surveys collected in the family's home at the beginning and end of services measured parenting variables, parent mental health and well-being, and child behavioral, social, and emotional well-being.
Parental substance abuse is a leading determinant of child maltreatment and, consequently, is often linked with negative clinical outcomes for children, exorbitant financial costs for the child welfare system, and serious social costs for the investigators nation. Yet, in spite of the seriousness of child maltreatment in the context of parental substance abuse and that there are well-established effective treatments for adult substance abuse, substance-abusing parents in the child welfare system are less likely to be offered services and receive services. Well-integrated treatments for the dual problem of substance abuse and child maltreatment are virtually nonexistent in the research literature. This study is a randomized controlled trial comparing Comprehensive Community Treatment to Multisystemic Therapy-Building Stronger Families (MST-BSF), an integrated model of two evidence-based treatments for parental substance abuse and child maltreatment that has shown promise in a 4-year pilot. Statement of Study Hypothesis: Compared to Comprehensive Community Treatment, parents receiving MST-BSF will show greater reductions in parental substance abuse and psychological distress, greater increases in employment, drug-free activities, social support, and positive parenting, and fewer incidents of reabuse of a child. Children whose families receive MST-BSF will experience fewer child out-of-home placements and greater reductions in internalizing symptoms such as anxiety.
The goal of this project is to examine the effects of the use of cellular-phone technology in conjunction with a parenting program entitled "Planned Activities Training (PAT)" on participant enrollment, engagement, and motivation for the PAT intervention, as well as on parent and child outcomes.
The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship. We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.
This is a population-based evaluation of the effectiveness of the Triple-P-Positive Parenting Program. Triple-P is a system of parenting programs with multiple levels that aims to provide parents with parenting skills and support.
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. It has been estimated that adverse childhood experiences account for 45%, 50%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts. There is also increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differently to treatment. The investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment and research. A potential barrier to the widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems. Therefore, the investigators have designed this observational study to test our hypothesis that answering questions about type and timing of childhood maltreatment are no more stressful than answering standardized mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT). The study will include representative national samples (by age, sex, and ethnicity) from the United States (total N=500, Ages 18-65) and will be conducted online via Prolific™, which maintains a pool of research participants. Participants will be assigned randomly to one of two test sequences. * In sequence 1, the Maltreatment and Abuse Chronology of Exposure (MACE) scale will be presented toward the beginning of the session and the Math/Verbal Test toward the end. * In sequence 2, the order will be reversed. The impact of completing the MACE and standardized IQ questions will be assessed before and after each module, using the abbreviated form of the Profile of Mood States (POMS).
This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA \[MiRNA\]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.
Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.
The PRESERVE \& CONNECT project is a multi-site randomized control trial of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC) in rural and racially and ethnically diverse communities in Vermont and Connecticut.
The goal of this clinical trial is to investigate how the friendship experiences of maltreated (i.e., abused and/or neglected) and non-maltreated adolescents differentially influence their risk for adverse outcomes. The main questions it aims to answer are: 1. How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents? 2. Which friendship experiences influence the associations between maltreatment and ability to regulate stress, as well as future mental health difficulties and revictimization? Participants will: * Attend the initial study visit on the campus of the University of South Carolina with their primary caregiver and a best friend during which they will: * Complete study questionnaires * Be connected to a device that records their physical ability to manage stress * Complete a task during which they will be audio and video recorded and complete a brief assessment rating how they are feeling at different times during task completion * Depending on which research group they are placed in, be assigned to discuss their experience doing this task with their friend (intervention group) or sit quietly in a room for 5 minutes (comparison group) * The follow-up study visit will involve completion of study questionnaires online or via mail 6 months later Additionally, the participant's caregiver and friend will complete study questionnaires. Researchers will compare the intervention group (debriefs with a friend) and comparison group (sits quietly for 5 minutes) to see if the presence of and discussion with the friend influences their physical ability to regulate stress and future outcomes.
Fathers are disproportionately involved in and responsible for family violence. Forty percent of maltreatment cases include the child's father, which is quite considerable when one considers mothers spend more time with the child during the day and engage in a greater variety of activities, relative to fathers. Importantly, the majority of child victims were those five and younger. Contrary to these potential negative impacts, fathers contribute positively to many aspects of child development and overall family functioning, making unique contributions to child peer relationships, language development, academic skills, and the proficiency of the other parent in parenting tasks. Thus, efforts to emphasize the father's role in the child's life, and attenuate any potential risks due to child or family directed violence, represent key public health initiatives within prevention efforts. There are many potential prevention programs that have been developed to support male caregivers. The Nurturing Fathers program and the Coaching Our Children: Heightening Essential Skills program are two examples of father-focused preventive intervention efforts. However, these approaches have not typically been evaluated as preventive interventions in community-based samples using scientifically rigorous methods. Thus, the present study aims to evaluate the effectiveness of these approaches in reducing family violence and improving male caregiver competencies in a randomized, controlled trial. Specifically, Nurturing Fathers Alone and Nurturing Fathers + COACHES will be compared to an attention control, and male caregivers and their children will be randomly assigned to one of the three groups.
The purpose of this study is to perform a program evaluation of the Navy and Marine Corps' New Parent Support Program (NPSP) home-visiting option. Both the Navy and Marine Corps have decided to pilot the Take Root Home Visitation (TRHV) curriculum, which is an evidence-informed, standardized program, with clients receiving NPSP home visits. This study is designed to examine the implementation and program effectiveness of TRHV compared to services as usual (SAU). Program outcomes include child development, parenting behaviors, child maltreatment risk and protective factors, and child maltreatment incidents. Implementation outcomes include clinicians' and clients' satisfaction with the program, clinicians' fidelity to the program delivery model, and clients' engagement with the program.
Smoke Free SafeCare (SFSC) is a proposed braided intervention consisting of two evidence-based interventions: Some Things are Better Outside (STBO), aimed at promoting smoke free home rules, and SafeCare, aimed at reducing child maltreatment and improving mother and child outcomes. STBO is effective in creating smoke free homes and reducing second-hand smoke in low-SES (socioeconomic status) households. SafeCare is an effective parent training program that is broadly disseminated in child protective services in the United States. SafeCare is a promising mechanism to effectively increase the reach of STBO to reduce SHS (secondhand smoke) exposure in families with documented high rates of tobacco use and children with cumulative risk for negative health outcomes.
Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.
This study aims to understand what influences the adoption and implementation of an innovative approach to pediatric primary care by medical professionals and staff providing that care. The innovation concerns addressing common psychosocial problems such as parental depression and substance abuse. Different approaches to training medical professionals will be examined as well as the use of software versus traditional 'paper and pencil' to facilitate implementation.
This is a pilot randomized controlled trial of a behavioral intervention focused on improving parenting skills and preventing child neglect in families of children with special health care needs. The intervention focuses on problem solving, distress tolerance, and emotional regulation skills.
The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for mothers receiving preventive services. The study intervention is adapted from Skills Training in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal and child well-being by reducing the effects of maternal PTSD and depression on parenting. The investigators plan to recruit mothers with high levels of trauma-related symptoms from preventive service agencies, and invite them to participate in the study. This study is a single group design, and data will be collected pre-treatment, post-treatment, and 12-week follow-up.
In this study, a computer-assisted adaptation of SafeCare, an evidence-based home visiting program, will be developed and tested in child welfare. This approach will assist home visitors with the delivery of SafeCare to families, with the goal of improving provider fidelity and implementation success. In the computer-assisted SafeCare sessions, a portion of the session will be delivered on a tablet computer that the home visitor brings to the family's home. The computer software will deliver the educational piece, or explain a piece of each session, along with modeling videos of the skills. The home visitor will follow up with the practice and feedback portions of the session. A randomized feasibility trial will be conducted to test the technology-based approach against the standard SafeCare implementation approach in terms of feasibility of implementation, provider job demands, and resources, as well as client outcomes such as skill acquisition and mental health.
The aim of this randomized controlled trial (RCT) is to conduct a second, independent evaluation the implementation and impact of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child maltreatment and improve child and family health and well-being. Durham Connects is the first home-visiting program that is designed to prevent child maltreatment and improve health and well-being outcomes in an entire community population. Program evaluation will test four hypotheses: 1) The program can be implemented with population reach, fidelity to the manualized intervention protocol, and reliability in assessment of family risk; 2) Random assignment to the Durham Connects program will be associated with lower rates of child maltreatment and emergency department maltreatment-related injuries, better pediatric care, better parental functioning, and better child well-being than assignment as control; 2) Intervention effect sizes will be larger for higher-risk groups; and 3) Community resource use and enhanced family functioning will mediate the positive impact of Durham Connects on outcomes.
The proposed study will compare purveyor coaching (conducted by National SafeCare Training and Research Center (NSTRC)) to local coaching that is supported by the purveyor (NSTRC). The outcomes of interest are home visitor fidelity and competence with the SafeCare model, and family engagement and skill acquisition. The study will also include a rigorous cost effectiveness analysis, and will examine individual and organizational factors that may affect implementation.
The study examines the effectiveness of parent-child Group Attachment Based Intervention (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting skills classes. GABI directly addresses the needs of isolated, marginalized families, with the goals of of enhancing parent coping and resilience, and improving parent-child attachment relationships. We hypothesize that compared to usual care, GABI will be associated with improved child, parent and parent-child outcomes.
The purpose of the project is to assess the initial efficacy of Stepping Stones Triple P-Positive Parenting Program (SSTP) with parents of children below age two with developmental disabilities to strengthen families and prevent child maltreatment.
The aim of this randomized controlled trial (RCT) is to evaluate the impact and mechanisms of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child maltreatment and improve child well-being. It is the first-ever RCT of a home-visiting program that is designed to prevent child maltreatment in an entire community population. Evaluation of program impact will test three hypotheses: 1) Random assignment to the Durham Connects Program will be associated with lower rates of child maltreatment and emergency department maltreatment-related injuries, better pediatric care, better parental functioning, and better child well-being than assignment as control; 2) Intervention effect sizes will be larger for higher-risk groups; and 3) Community resource use and enhanced family functioning will mediate the positive impact of Durham Connects on outcomes.