26 Clinical Trials for Various Conditions
The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.
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.
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.
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.
Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others
Child maltreatment is a leading cause of death and disability in children. More than 3 million reports to Child Protective Services are made every year in the US and almost 1,600 children die annually due to maltreatment. Children who are victims of maltreatment often have significant lifelong adverse health, social, and economic consequences. Accurate and timely recognition of the early signs of child maltreatment is critical to decreasing morbidity and mortality. A significant proportion of children who suffer severe morbidity and/or mortality from maltreatment had been previously evaluated by physician(s) who did not recognize the abuse. The American Academy of Pediatrics has evidence-based recommendations for the testing which should be done as part of the medical evaluation of children with suspected physical abuse. However, despite these evidence-based recommendations, physicians fail to consistently screen for and evaluate for abuse even in high-risk situations. The investigators have developed and evaluated what the investigators believe to be the first, comprehensive electronic health record (EHR) based child abuse clinical decision support (CA-CDS). This EHR-based CA-CDS system informs medical care at multiple points during the care for a potentially maltreated child, beginning with identification of suspected abuse to the handing off of information to CPS which has a mandate to protect children who are victims of suspected maltreatment. The investigators are disseminating the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system which they developed as part of the investigator's initial PCORI grant. 1. a universal child abuse screen (CAS) - supports identification of maltreatment 2. an embedded child abuse alert system - supports identification of maltreatment 3. alerts to physicians and advanced practice providers - supports identification of maltreatment 4. physical abuse order set - supports proper evaluation of suspected physical abuse 5. documentation assistance for making reports of suspected maltreatment to Child Protective Services - supports mandated reporting The primary objective is to disseminate and implement CA-CDS in two different EHRs in two hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess whether the CA-CDS improves identification, evaluation and mandated reporting of child maltreatment. Aim #1 is to compare the rates of identification of possible child abuse - defined as reports to Child Protective Services - before and after integration of CA-CDS into the EHR among children presenting to 5 Emergency Departments in two different health systems. Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS into the EHR in 5 Emergency Departments in two health care systems. Once the D\&I is complete, the investigators will have demonstrated the feasibility of implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a critical step towards the goal of having a CA-CDS as a standard EHR component.
The proposed stage 1 intervention development study is designed to address two significant co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce family violence because SA treatment alone does not result in an end to these behaviors. Currently available interventions have had little success in reducing male IPV. Fathers for Change, an integrated outpatient intervention, shows promise as an intervention model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers as a motivation for change and targets factors that are known to trigger SA, IPV and CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not been integrated and tested as part of a residential substance abuse program for men. This project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed by comparing it to PE in the areas of: participant completion rates, hostile cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in hostile cognitions and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces relapse, IPV and CM risk behaviors.
Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact of iLook Out for Child Abuse, an online, interactive learning module about reporting suspected child abuse. Delivered via a learning management system to early childhood professionals who work with infants and young children, this study assessed iLookOut's effect on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting suspected child abuse; and 3) preparedness to protect children at risk. Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and increase self-reported preparedness of early childhood providers to report suspected child abuse. Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same measurements as Phase 1, and is available for use (free of charge) for all childcare providers in Pennsylvania at https://www.ilookoutforchildabuse.com.
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.
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.
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 will implement and evaluate a mentoring program designed to promote positive youth development and reduce adverse outcomes among maltreated adolescents with open child welfare cases. Teenagers who have been maltreated are at heightened risk for involvement in delinquency, substance use, and educational failure as a result of disrupted attachments with caregivers and exposure to violence within their homes and communities. Although youth mentoring is a widely used prevention approach nationally, it has not been rigorously studied for its effects in preventing these adverse outcomes among maltreated youth involved in the child welfare system. This randomized controlled trial will permit us to implement and evaluate the Fostering Healthy Futures for Teens (FHF-T) program, which will use mentoring and skills training within an innovative positive youth development (PYD) framework to promote adaptive functioning and prevent adverse outcomes. Graduate student mentors will deliver 9 months of prevention programming in teenagers' homes and communities. Mentors will focus on helping youth set and reach goals that will improve their functioning in five targeted "REACH" domains: Relationships, Education, Activities, Career, and Health. In reaching those goals, mentors will help youth build social-emotional skills associated with preventing adverse outcomes (e.g., emotion regulation, communication, problem solving). The randomized controlled trial will enroll 234 racially and ethnically diverse 8th and 9th grade youth (117 intervention, 117 control), who will provide data at baseline prior to randomization, immediately post-program and 15 months post program follow-up. The aims of the study include testing the efficacy of FHF-T for high-risk 8th and 9th graders in preventing adverse outcomes and examining whether better functioning in positive youth development domains mediates intervention effects. It is hypothesized that youth randomly assigned to the FHF-T prevention condition, relative to youth assigned to the control condition, will evidence better functioning on indices of positive youth development in the REACH domains leading to better long-term outcomes, including adaptive functioning, high school graduation, career attainment/employment, healthy relationships, and quality of life.
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.
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 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 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.
Our broad goal is to help prevent child maltreatment (CM) by modifying pediatric practice to be more responsive to prevalent psychosocial needs of many children and families.Training pediatricians to address key risk factors for CM, the Safe Environment for Every Kid (SEEK) model aims to support parenting and family functioning, reducing the risk for CM while helping promote children's health, development and safety. We are building upon the existing pediatric primary care system and strengthening the training of pediatricians. The project also builds on our extensive research and clinical expertise in CM and in prevention (Black \& Dubowitz, 1999, Dubowitz et al., 1998, 1999, in press; Dubowitz \& Guterman, 2005, Gaudin \& Dubowitz, 1997). We have developed and implemented an enhanced model of pediatric primary care, taking advantage of the enormous opportunities of the existing pediatric primary care system, with its regular contact with young children and parents (Dubowitz \& Newberger, 1989; Dubowitz, 1989, 1990; Green, 1994). Pediatricians typically devote over half their time to checkups, focusing on prevention. There is increasing recognition that pediatric care must incorporate aspects of parental and family functioning and collaborate with community resources (Academy of Pediatrics, 1998; Green, 1994b). The broad goal of this project is to implement concepts that have been embraced by the field of pediatrics, but have not been applied and tested.
The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.
The study will examine the extent to which a group motivational intervention (ME) impacts retention, treatment compliance, and long-term outcomes in families with a history of, or high risk for, child maltreatment.
The purpose of this study is to examine the efficacy of techniques to enhance participation in parenting programs.
This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs.
Trauma-informed treatment will improve emotional regulation and behavior.