133 Clinical Trials for Various Conditions
At Yale New Haven Hospital, parents on the postpartum ward receive a Take 5 program to help train and prepare parents for strategies to manage their infant's crying. Inconsolable crying is a leading cause for abusive head trauma (AHT) in infants, and the Take 5 program has proven effective in reducing rates of AHT. However, it is also important to examine new ways of improving AHT preventative programs to optimize outcomes for infants. The purpose of this proposal is to determine whether adding a one-minute audio-clip of an infant crying, which specifically addresses AHT, to the Take 5 message given to parents of newborns on the postpartum floor of the hospital strengthens the preventive message. This is a randomized controlled trial (RCT) of parents on the postpartum ward; half will receive just Take 5, and the other half will receive the audio-clip and Take 5. Our hypotheses to be tested are that relative to parents who had Take 5 alone, those parents who hear the audio-clip before learning Take 5 will: 1. Have higher HR/BPs and higher negative affect after the training session 2. Be more likely to remember use Take 5 when they became frustrated with their infant's crying when followed up 6 weeks later. 3. Be more likely to tell other people about Take 5 and be more likely to say Take 5 was useful.
Preliminary controlled trial of a brief intervention designed to reduce child maltreatment risk among low-income pregnant mothers. Foci will include major risk factors for maltreatment, including substance abuse, social isolation, depression, violence exposure, and maladaptive child-rearing attitudes/beliefs.
This proposed randomized controlled trial will examine whether gamified micro-learning is a feasible and effective way to promote long-term learning about child abuse and its reporting. After completing the interactive online learning program, iLookOut for Child Abuse, early childhood professionals will receive brief (5-10 minute) gamified learning exercises to complete on their smart-phones. By measuring knowledge (and other outcomes) over time, the investigators will determine how much knowledge decays over various time periods, how well micro-learning can remediate that decay, and whether such a 2-phase intervention is feasible for helping early childhood professionals be better prepared to identify and report suspected child abuse.
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.
This five-year study aims to improve childcare provider (CCP) reporting of suspected child abuse by means of an online learning module, iLook Out for Child Abuse. Using an interactive, video-based story-line (along with follow-up activities), iLookOut engages CCPs emotionally and intellectually to take the first step in addressing the epidemic of child abuse -which in the U.S. claims \>680,000 confirmed victims annually. The consequences of child abuse can be devastating and long-lasting. The purpose of this study is to establish an evidence-based intervention that can help those who care for young children recognize and report suspected child abuse before irreparable harm occurs.
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.
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.
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 purpose of this study is to assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse.
This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).
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.
This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention.
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.
An intervention study to provide in-the-moment parenting tips with the goal of increasing healthy parent-child interactions leading to resiliency in high-risk children. Specifically, in a sample of parents participating in HV programs, the investigators will use a smartphone app (mHealth app) to deliver daily tailored messages with tips on monitoring and promoting child development. Daily assessments of parents' emotions, parenting behaviors, and interactions with their children will also be collected via the app. During the 4-week EMA study, parents will receive either 2 weeks of the mHealth intervention + EMA data collection followed by 2 weeks of only EMA data collection or to receive 2 weeks of only EMA data collection followed by 2 weeks of mHealth intervention + EMA data collection.
Birth parents of young children who have been placed into foster care are a highly vulnerable population of caregivers. Little is known about the ability of existing prevention programs to intervene with birth parents who have recently been reunified with their children under the age of six. This project aims to evaluate a brief, home-visiting intervention model with a sample of reunified birth parents, examining its effectiveness to improve parenting and child wellbeing, and reduce reoccurrence of maltreatment and reunification failure.
The Quality Improvement Center on Domestic Violence in Child Welfare (QIC-DVCW) is a five-year federal cooperative agreement with the Children's Bureau to test an approach to improve how child welfare agencies and their partners work collaboratively to help families experiencing domestic violence. The safety and well-being of child survivors of domestic violence and child maltreatment are closely connected to the safety and well-being of the adult survivor of domestic violence. For this reason, the QIC-DVCW is testing an Adult \& Child Survivor-Centered Approach to addressing the needs of both the parent and child, which includes effectively engaging and working with the person causing them harm. The following four research questions were developed to guide the work of the Recipient's evaluation of the QIC-DVCW, and Provider's data will help to answer these questions: 1. Does a collaborative, adult and child survivor-centered approach-that includes safely engaging and establishing accountability of the DV offender-improve adult and child survivor safety, child permanence, and child and family well-being for child welfare involved families experiencing DV? 2. For which families and in which social contexts does an adult and child survivor-centered approach improve these outcomes? 3. What factors are associated with successful implementation and sustainability of an adult and child survivor-centered approach? 4. What are the costs associated with the implementation and maintenance of an adult and child survivor-centered approach, and how do these costs compare to the costs of "practice as usual"?
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 evaluates the feasibility, acceptability, and impact of a collaborative care practice for infants investigated by state Child Protective Services (CPS) for suspected maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of life, as well as the frequent contact of infants with health care providers in the first year of life, the investigators will conduct a RCT to measure the impact of a collaborative practice model linking CPS caseworkers with primary health care providers during an investigation for suspected infant maltreatment. With this trial, the investigators will ask (3a) Can a collaborative practice model improve parent-reported infant health-related quality of life 6 months following child welfare involvement for suspected infant maltreatment? and (3b) Does a collaborative practice model impact repeat child welfare involvement for suspected child maltreatment over 6 months?
This study will examine the incremental benefit of animal-assisted therapy (AAT) as an adjunct intervention when combined with Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for the treatment of maltreated youth. In addition, the development of therapeutic rapport and the intensity of stress experienced during treatment sessions will be examined as mediational mechanisms of treatment outcome. This project will help determine whether a larger study to test the beneficial effects of AAT for maltreated youth is feasible and warranted.
Child maltreatment, particularly neglect, disproportionally affects low-income children with special health care needs (CSHCN) and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. Child Abuse Prevention Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children. This study is a multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child neglect, adherence to recommended medical care, and family stressors and strengths.
This is a randomized, controlled trial (RCT) of Parent-Child Interaction Therapy (PCIT) designed to test the effects of PCIT on self-regulation and behavior in child maltreating (CM) parents and their elementary-school children. Two hundred-fifty (250) maltreating mothers and their children (age 5-8 years) will be drawn from Child Protective Services and randomized to the PCIT intervention or a control condition (services as usual). Key contextual risk factors will be assessed, including cumulative risk, parent mental health, and parent substance use. A multirater, multimethod approach to assessment will include measures of self-regulation, parenting skills and children's behavior outcomes. Families will be followed to 1 year for CM recidivism. Findings from this proposed study are expected to have significant implications for optimizing CM parenting interventions by (a) determining the sensitivity of CM parent and child neurobehavioral self-regulation systems to intervention, and (b) identifying individual differences in self-regulation that mediate and moderate response to intervention and long-term maintenance of gains.
The study evaluates the feasibility and effectiveness of a well-documented relationship-based intervention (Promoting First Relationships), compared to a resource and referral condition, in improving outcomes for families of infants and toddlers referred to Child Protective Services (CPS) for maltreatment. In addition, it evaluates the effectiveness of training community social service workers in providing the intervention.
This is a multi-county randomized controlled trial of the Fostering Healthy Futures (FHF) preventive intervention program (consisting of mentoring and skills groups) with 256 maltreated preadolescent youth in out-of-home care. It is hypothesized that participation in the FHF program will result in better functioning in cognitive, social, and behavioral domains, and that these gains will result in improved mental health functioning, quality of life, and reductions in problem behaviors and adverse life-course outcomes.
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.
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.
The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly Visits with case management referrals to community services as usual, and to determine whether participation in the program reduces the number of reports for child maltreatment within the first seven years of the child's life.
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.
This study will determine the effectiveness of abuse-focused cognitive behavioral therapy that is provided by a community health clinic in addressing the behavioral and emotional health needs of children and adolescents whose parents have used physical disciplinary action.
This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.
This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.