63 Clinical Trials for Various Conditions
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.
The objective of the study is to evaluate the efficacy of an online intervention (the Parents Support Program) aimed at increasing supportive behaviors among parents of transgender youth. The intervention consists of three modules that include a variety engaging activities such as social perspective taking exercises, writing prompts, videos of parents, youth, and experts, and psycho-educational materials. The study uses an experimental design with a waitlist control. Both the experimental and control groups will complete a pre-test, one month follow up, and two month follow up survey. Targeted outcomes include knowledge about gender diversity, attitudes about trans youth, and supportive parenting behaviors.
BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available. OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depressionÍž infant health care utilization, and immunization status. METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months. PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depressionÍž infant health care utilization and immunization status. ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.
The purpose of this study is to develop and test a social media-based (Facebook) intervention that provides support and skills to parents with adolescent children in treatment for substance abuse. The Facebook intervention, PURPOSE, will be 8 weeks long and led by other parents (peer leaders). Peer leaders will go through 2 2-3-hour training sessions and be assessed at the end to confirm their understanding of study protocol and procedures. The study PI will lead 2 short (2-weeks) trial tests of various segments of the intervention to test out content and procedures. Then, a pilot trial with 80 parents, 40 randomized to PURPOSE and 40 randomized to treatment as usual (TAU), will be done to test how useful PURPOSE can be in promoting parents' engagement in their child's treatment and recovery while reducing their own distress and feelings of shame/stigma. Parents will do a phone interview at the start of PURPOSE and again at the end of the 8 weeks.
The purpose of this study is to determine whether a nutrition and physical activity education program for families of overweight or obese adolescents with Down syndrome is more effective when behavioral lifestyle change strategies are added.
The goal of this clinical trial is to learn if Grief-informed Parent Support sessions offered weekly to parents with a child in the pediatric intensive care unit work to decrease symptoms of parent grief compared to a non-grief informed parent support program offered weekly to parents with a child in the pediatric intensive care unit. The main question is: Do parents with a child in the pediatric intensive care unit report fewer symptoms of grief, such as depression and anxiety, following their attendance at a parent support program with a grief-informed intervention compared to parents who receive a non-grief informed support program. Participants will be randomized to : Receive a 8-session grief-informed parent support program or a 8-session non grief-informed parent support program. Parents will report symptoms of grief before and after the 8-session parent support program.
BACKGROUND: The Defense Health Agency (DHA) and the Office of Military Community and Family Policy (MC\&FP) requested assistance in evaluating the effectiveness of a military pilot implementation of a civilian program designed to assist families with infants called HealthySteps (HS; HealthySteps National Office, 2018). HS is a unique pediatric primary care-based program that helps families identify and manage parenting challenges. The program interweaves the medical support of the pediatrician's office with the resources and services of a HS Specialist trained to help parents understand their infants' needs (e.g., feeding, behavior, sleep) and their role as caregivers. HS Specialists provide enhanced educational support and facilitate targeted referrals to other relevant DoD and civilian support resources. OBJECTIVE: The HS program has not been widely implemented or evaluated previously in a military context. However, a small 2-site pilot was initiated in 2017 by MC\&FP to assess the feasibility of offering the HS program in military treatment facilities (MTF). The Defense Health Agency (DHA) further determined that this pilot program could be expanded to fulfill a 2019 National Defense Authorization Act (NDAA) requirement for the implementation and evaluation of a pilot program to reduce risk factors for child abuse and neglect within the U.S. military community. APPROACH: This outcome evaluation study entailed a review of medical records for families enrolled in the HS pilot as well as the collection of prospective survey data. Survey data collected from primary caregivers enrolled in HS at seven implementation locations throughout the U.S. is being compared with survey data collected from caregivers of newborns seeking care at control locations offering pediatric treatment as usual. VALUE: The HS program is expected to improve parental engagement in well-baby care, increase targeted screenings and referrals, improve parental efficacy and knowledge, as well as facilitate integration and utilization of existing family services available across disparate military support settings. It also is expected to increase military service satisfaction and perceived support among military parents. Summary reports of study results will be provided to MC\&FP, DHA, and Congress. RESEARCH COLLABORATORS: NHRC is a Department of the Navy Bureau of Medicine and Surgery research command located in San Diego, California. Abt Global is a leading civilian professional research corporation with extensive experience in military health research. Investigators from these two institutions are collaborating to conduct this outcome evaluation. STUDY POPULATION: Participating pilot program clinics included 7 military pediatric clinic locations selected by DHA and serving personnel and their families from all U.S. military service branches. All families with children aged 0-4 months seeking well-baby care at participating MTF pilot pediatric clinics were eligible for HS program services and for study recruitment. Additionally, beneficiaries similarly seeking care for a newborn at 11 MTF pediatric clinics providing treatment as usual were eligible for the comparison condition. Medical records for this population were reviewed and prospective survey evaluation data were collected and merged together for ongoing analysis and reporting.
There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the community) can be effective in reducing hospitalizations for asthmatic children. This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to reduce asthma-related pediatric hospitalizations and emergency department visits.
This project aims to adapt the parent component of Safe Alternatives for Teens and Youth (SAFETY) outpatient intervention to SAFETY-Parent (SAFETY-P), a self-paced interactive learning module for parents, to be implemented as an augmentation for youth being seen for suicidal ideation, suicidal behavior, or recent suicide attempts across multiple settings at Nationwide Children's Hospital (NCH, Columbus, Ohio).
This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their child's mental health. This research has the potential to improve services for families seeking emergency psychiatric support, with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable, cost-effective, accessible tools.
Parents of children who die traumatically or unexpectedly from things like suicide or an overdose suffer from mental and physical health problems and can experience massive disruptions in their family life. For about half of these parents, the first, and sometimes only, interactions they have with the healthcare system when their child dies are with a medical examiner or coroner (hereafter 'ME'). But MEs have little to no training in helping grieving families, and there are no standards guiding medical examiners or coroners on how or even if they should help grieving families. This gap leaves parents to find the help they need on their own. This research will test two different strategies for addressing this gap in the healthcare system.
Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.
Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.
The need for assisted-technology at home reflects some of the most serious health-related conditions faced by children with physical and developmental disabilities. 'Technology-dependent' is often used in the literature to describe children "who need both a medical device to compensate for the loss of a vital body function and substantial and ongoing nursing care to avert death or further disability". Parenting a child is stressful and challenging, and even under ideal circumstances the care of a child with complex needs requires greater than normal parenting skills. Studies have showed that parents of children whose illness require assisted-technology experience significant emotional stress, potential gaps in social support, and social isolation leading to lower quality of life, unhealthy family functioning, and negative psychological consequences. This study intends to assess the feasibility and efficacy of a tele-psychotherapy (Tele-P) intervention as a way to promote the emotional functioning of parents and to help increase the quality of life of children that are technology-dependent in the Greater Boston Area. It is hypothesized that parents who adhere to psychotherapy sessions via videoconferencing (Tele-P) will demonstrate significant reductions in symptoms of depression, anxiety and social isolation. Children of parents in the (Tele-P) condition will show significantly greater improvements in their quality of life including their physical health, mental health, family life, free time, and general life enjoyment. A randomized controlled trial is proposed in order to evaluate the feasibility and efficacy of a tele-psychotherapy intervention for parents of technology-dependent children at the Critical Care, Anesthesia and Perioperative Extension (CAPE) program in Boston Children's Hospital. This study will serve as model for social workers to perform an intervention for parent's raising technology-dependent children. This study proposes that tele-psychotherapy be a means of advocating for this underserved population.
The goal of this project is to develop and test e-Unstuck, an e-learning intervention that (1) provides advanced training to parents of children with Autism Spectrum Disorder without Intellectual Disability (ASDwoID) on how to implement the evidence-based Unstuck and On Target (UOT) curriculum at home and (2) is built on 3C's proprietary, state-of-the-art, Dynamic e-Learning Platform, an established platform with high ratings of quality, value, usability, and feasibility from end users. As a result of the pilot efficacy test, the investigators hypothesize that (1) parents who interact with the e-Unstuck software will report greater knowledge and use of UOT principles, less parenting stress and greater parenting sense of competence, and improved child executive function (EF) and social skills compared to control parents, (2) parents who spend more time engaged with the intervention will show greater improvements in outcome variables, and (3) parents who interact with the e-Unstuck software will find the software to be of high quality, value, usability, and feasibility.
The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.
This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
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.
The goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.
After the initial hospitalization, parents of children newly diagnosed with cancer assume responsibility for assessing and managing their care; however, parents are often overwhelmed with information received throughout the hospitalization and are apprehensive about caring for their child at home. Parents want concise, focused information on how to care for their child after the hospital discharge. Two parent education discharge support strategies (PEDSS) were created to use at hospital discharge. PEDSS consists of a symptom management intervention and a support for the caregiver intervention. A cluster randomized control trial will assess the effectiveness and feasibility of the two different interventions.
The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. While there have been large advances in diagnostic assessments like genetic and endocrine testing, the tests do not always show what caused the DSD. And, even when the tests do reveal an explanation for the DSD, knowing what happened genetically or hormonally does not usually lead to a single "correct" treatment plan. Instead, it is likely that there are different acceptable treatment options - and parents will need to make decisions based, in part, on their personal preferences, values, and cultural background. Adding more stress to the situation is knowledge that many of the decisions that need to be made by parents early in a child's life are irreversible and exert life-long consequences for the child and the family. To support parents becoming actively involved in making such decisions, and to reduce the likelihood of future worry and regret about decisions that have been made, the investigators will create a decision support tool (DST). The DST will help educate families about typical and atypical sex development of the body, the process by which DSD are diagnosed (especially how to interpret genetic test results), and possible relationships between diagnostic/genetic testing, decisions about care, and known consequences of those decisions on their child and entire family. The DST will be used by parents of young children together with their child's health care provider. The investigators will bring together a network of researchers, health care providers, representatives of patient support and advocacy organizations, and parents of children with DSD to share their experiences. Participants of this network will be involved at each stage of creating the DST, revising it, and putting it into practice. At the end of this project, the investigators will have a fully formed DST that will be available for parents to use with their child's healthcare team as they are first learning their child may have a DSD.
Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts.
This study tests the effectiveness of parent and family oriented support interventions that are designed to help with weight loss among African American families. Obesity tends to run in families, thus family based interventions, with parents as main change agents have been strongly recommended. The parent and family oriented support Interventions may help facilitate weight loss among African American families.
Children presenting to the University of Iowa Health Care System (UIHC), Blank Children's Hospital (Blank), Children's Hospital of Minneapolis, and Kansas City Mercy Children's Hospital with an injury resulting in admission will be the sample population. A child will be included if they are 10-17 years old with an unintentional injury. Consenting children and their parents will be asked to complete a series of four questionnaires: before hospital discharge, at 1-month post discharge, 3-months and 6-months post discharge. The parent-child dyads will be randomized (1:1) to receive 1) training in Link for Injured Kids or 2) Trauma Education. The survey completed in the hospital will be a paper survey or online via an iPad, and follow-up surveys can be completed on paper or online. Aim #1: Assess the feasibility of Link for Injured Kids through qualitative research with parents and providers of previously injured children from UI Children's Hospital. Aim #2: Through a randomized trial, determine the range of potential psychosocial and behavioral health indicators possibly impacted by Link for Injured Kids. This will identify the types of outcomes which could include post-traumatic stress disorder (PTSD), depression, nonspecific distress, quality of life, absenteeism, school performance, coping skills, communication skills, and access to mental health.
Background: - Studies show that Internet Support Groups (ISGs) can help parents of children with chronic conditions. Researchers want to find out if ISGs can help parents of a child with the genetic disorder Neurofibromatosis Type 1 (NF1). Objective: - To see if an ISG for parents with a child with NF1 can give the parents more social support and less anxiety. Eligibility: - Adults age 18 and older with a child (age 0 25 years) with NF1. Design: * Participants will register for the study on a website hosted by the Children s Tumor Foundation. * Participants will complete 5 questionnaires. These will be about their emotional well-being, their child s health status, and their contact information. * The ISG will include a Discussion Forum that participants can enter 24 hours a day, 7 days a week. A professional moderator will post questions and discussion topics. The moderator can also respond to questions. They will be a psychologist, a psychology associate, or a nurse-practitioner. Each one will be highly experienced at working with young people with NF1 and their families. * The ISG also will contain a chat room. Here participants can chat with other users in real time. The chat room will be open for one 90-minute session per week. * The ISG will remain open for 8 weeks. Then participants will retake 4 of the questionnaires from the beginning of the study. They will also complete 1 other questionnaire about their experiences with the ISG. Information from any messages participants post on the ISG website will be collected. * Three months after the ISG closes, participants will complete the questionnaires one final time.
This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.