82 Clinical Trials for Various Conditions
The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.
This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. Behavioral and social problems are likely to interfere with school adjustment. The investigators hypothesize that children who receive the intervention will show better school readiness and school adjustment outcomes.
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).
Purpose: This study will examine brain activity in children age 10-18 with disruptive behavior problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD), compared with children without behavioral problems. Our goal is to examine differences in how emotions, social situations, and problem-solving situations are processed in the brain across these groups of children.
Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused interventions effectively prevent behavioral health problems such as depression and conduct disorders and can provide a downstream economic benefit to society by reducing criminal activity, education costs, and health care use. Unfortunately, parenting programs are not widely available, accessible, nor well-attended. Pediatric primary care is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal contact point to increase access. However, primary care clinicians (PCCs) often have insufficient training in behavioral health topics and typical referral practices are inadequate. There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to develop effective referral practices in conjunction with increasing the accessibility of parenting programs. The study long-term goal is to prevent significant behavioral health problems through widespread access to effective and accessible parenting programs through primary care referrals. In this study there are two trials: First is the primary care clinicians "PCC" trial, testing the effectiveness of referral training (aim 1). Second is the parents "eGen" trial provided by therapists, testing the effectiveness of eGen parenting intervention (aim 2).
This study will look at who does not improve after doing a behavioral parent training program briefly through telehealth. It will also study ways to make the intervention better for those that do not improve.
The purpose of the proposed study is to evaluate the impact of a behavioral intervention team (BIT) on 2 adult units: a general medical (8N); a cardiac/medical stepdown (8S) at Vanderbilt University Medical Center (VUMC) with a higher proportion of patients with behavioral health comorbidities.
The purpose of this project is to conduct a follow-up study with women that had participated in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink and Blue Kids Study is a follow-up study with the mothers and also with the children they were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8 years old, which is a perfect time to look at developmental outcomes in children. This study will look at children with exposure to nicotine or antidepressants during pregnancy, as well as children who were not exposed. The investigators hypothesis is that children who were exposed to either nicotine or antidepressants in pregnancy will have poorer developmental outcomes than children who were not exposed. The investigators are also interested in determining whether nicotine exposure or antidepressant exposure results in poorer outcomes. The investigators specific aims are: 1. To determine whether pre-school and school aged offspring exposed to maternal cigarette smoking or antidepressants during pregnancy are more likely to have social-emotional problems compared to children who were not exposed to cigarettes or antidepressants during pregnancy. 2. To determine whether pre-school and school aged children who were exposed to prenatal maternal cigarette smoking or antidepressants during pregnancy display cognitive impairments as compared to children who were not exposed to either prenatal maternal cigarette smoking or antidepressants. 3. To determine if pre-school and school aged children who were exposed to maternal prenatal cigarette smoking or antidepressants display impaired motor development as compared to children who were not exposed to maternal cigarette smoking or antidepressants in pregnancy.
This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special education students in behavioral classrooms. The program includes multiple service components: the RECAP classroom mental health curriculum, which develops students' behavioral and social skills; reading intervention; individualized skills training; and parent group. Schools are randomly assigned to the treatment or control group. This two-year multi-component mental health and academic intervention is hypothesized to improve students' mental health, social skills, and academic functioning.
This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.
This study has two phases: Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers. Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers
In partnership with a multi-site, Los Angeles-area community clinic consortium, North East Valley Health Corporation (NEVHC), the investigators will use telehealth to integrate pediatric developmental, behavioral and mental health (DB/MH) services into primary care for low-income, publicly insured children. During Project Year 1, the investigators used qualitative methods to conduct and analyze interviews with parents, clinicians, and staff at NEVHC to assess their perspectives on the delivery of child DB/MH services and on a potential telehealth-based patient visit, coordination, and clinician education system for the provision of DB/MH specialty care in primary care settings to children ages 5-12. This data was used in a stakeholder-engaged process to customize a telehealth-based delivery system for pediatric DB/MH services that can be integrated into primary care settings. During Project Years 2-3, the investigators will conduct a cluster randomized controlled trial (RCT) to compare the customized telehealth-based patient visit, coordination, and clinician education system to the usual in-person, community- based referral system at NEVHC. This study will examine whether a telehealth developmental, behavioral and mental health delivery model can be an effective, efficient, and family-centered way to provide integrated DB/MH services to children in low-income communities.
This study compares the effectiveness of Child Parent Psychotherapy to that of usual care (defined as: referral to therapists in the community or Columbia University Medical Center) in improving maternal depressive symptoms and child emotional and behavioral disturbances. The investigators will recruit mothers who report being mildly to moderately depressed and their preschoolers (ages 3-5 years) who they are concerned are exhibiting emotional and/or behavioral problems.
The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts. Building on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.
The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.
In the present study, investigators aim to (1) adapt the Making Connections Intervention (MCI) as an intervention to address telehealth engagement and examine whether this targeted intervention can improve youth engagement in telehealth treatment; and (2) assess attitudes towards help-seeking and therapeutic alliance from both the youth and clinician viewpoint to examine the impact of these factors on engagement in telemental health treatment. Forty adolescent participants ages 12-18 will be randomized to either telehealth treatment as usual (TAU) plus the telehealth Making Connections Intervention (MCI-T) engagement session or telehealth TAU alone and followed for 12 weeks from baseline assessment. All clinicians will receive training in the MCI-T intervention and provide either MCI-T + usual care or usual care only depending on the condition to which the adolescents are randomized. All evaluations and therapy sessions will be done over telehealth platform.
The Mindful Parenting and Parent Training Study will be investigating the combination of Bögels and Restifo's (2014) Mindful Parenting Program and Chorpita and Weisz's (2009) Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH) Program, specifically the BPT module. The Mindful Parenting Program is an adaptation for parents of the Mindfulness-Based Cognitive Therapy, and the Mindfulness-Based Stress Reduction program; the program will consist of 7-weekly 2.5-hour parent group sessions. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1.5-hour sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection. Both evaluation and treatment services will be offered at no cost to study participants. Parents, children, and teachers will also be offered monetary incentive to thank them for their time and effort completing study related assessments throughout the course of the study to determine if the combination of the Mindful Parenting Program with BPT improves functioning in children with disruptive behavioral problems, as well as the parent-child relationship and the parent's acquisition and enactment of the skills they learn in BPT.
The Clinic Treatment Project tested two alternative methods of delivering evidence-based practices within public community-based mental health clinics, using training and supervision procedures designed for the settings and users.
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.
This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.
The investigators propose to create e-Connect, a new service delivery model that will enable real time identification and targeted, county-specific referral and linkage of participants with suicidal behavior (SB) and related behavioral health (BH) problems. e-Connect will: (i) establish and formalize interagency referral decisions based on clinical need, jointly derived by JJ (juvenile justice) and BH agencies; (ii) train probation staff to increase BH/SB understanding; (iii) utilize an existing evidence-based (EB) BH/SB screen; and (iv) develop a mobile application to seamlessly integrate screening, classification of clinical need and development of a related referral plan. There are 4 project phases: Development, Baseline, Implementation, and Sustainment/Evaluation. After development, activities take place in 10 NY (New York) counties and all study counties will begin the intervention at the same time. The investigators will examine changes in outcomes (e.g., service use) relative to baseline in (i) identification of participants service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) participants BH service use (access and engagement). Analyses will further consider contributions of multi-level factors (e.g., staff, organizational, family, and community) that influence implementation (feasibility, acceptability, sustainability) of e-Connect across various probation department processing categories (e.g. status offenders, diversion cases). The investigators will consider the role of mediating elements (e.g., probation practices) in explaining the association between e-Connect and identification, referral, and service use.
Behavioral problems are part of many of the chronic diseases that cause the majority of illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse, failure to take treatment, sleep problems, anxiety, depression, and stress are major issues, especially when chronic medical problems such as heart disease, lung disease, diabetes, or kidney disease are also present. These behavioral problems can often be helped, but the current health care system doesn't do a good job of getting the right care to these patients. Behavioral health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychological and social factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer ways have been proposed for helping these patients. In co-location, a behavioral health clinician (such as a Psychologist or Social Worker) is located in or near the primary practice to increase the chance that the patient will make it to treatment. In Integrated Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team. The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve outcomes? The key decision affected by the research is at the practice level: whether and how to use behavioral health services. The investigators plan to do a randomized, parallel group clustered study of 3,000 subjects in 40 practices with co-located behavioral health services. Practices randomized to the active intervention will convert to IBH using a practice improvement method that has helped in other settings. The investigators will measure the health status of patients in each practice before and after they start using IBH. The investigators will compare the change in those outcomes to health status changes of patients in practices who have not yet started using IBH. The investigators plan to study adults who have both medical and behavioral problems, and get their care in Family Medicine clinics, General Internal Medicine practices, and Community Health Centers.
This research is being done to: * identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems, * learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.
The goal of this clinical trial is to compare a novel tactic for mitigating reinstatement compared to the current standard of care approach using a translational-treatment model. The main questions it aims to answer are: 1. how well does progressive ratio training mitigate response-dependent reinstatement compared to the standard of care approach? 2. how well does progressive ratio training mitigate response-independent reinstatement compared to the standard of care approach?
Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.
Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.
The goals of this clinical trial are to identify factors associated with the development of problem behavior in Cornelia de Lange syndrome (CdLS) and to develop an effective behavioral assessment and treatment model for problem behavior in children with CdLS. The hypotheses are as follows: 1. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit preferences for auditory stimuli relative to other categories (e.g., visual, tactile) of stimuli. 2. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit problem behavior to obtain adult attention or to escape task demands relative to tangible and control conditions, as measured by functional analysis results. 3. Function-based behavioral treatments will reduce problem behavior in individuals with CdLS by 80% or greater relative to baseline rates. 4. Individuals with CdLS and problem behavior will exhibit more impaired communication, demonstrate increased emotion dysregulation, and exhibit more severe symptoms of Autism Spectrum Disorder (ASD) relative to those with CdLS and no problem behavior. Participants in the intervention group (families of children with CdLS and problem behaviors) will be asked to complete study measures and attend 2 full days and one half-day of clinic services at Kennedy Krieger Institute so that the study team can provide assessment and treatment of child problem behaviors, and then train parents to apply the intervention. Participants in the control group (families of children with CdLS and no problem behavior) will be asked to complete study measures once every 3 months for a 2-year period to monitor the children. This study will improve the ability to effectively treat problem behavior is CdLS, as well as identify key variables associated with problem behavior in CdLS which may be examined in future studies and clinical practice to foster early intervention and prevention efforts.
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer's disease (AD).