8 Clinical Trials for Various Conditions
The overall goal of the project is to develop a feasible, effective and sustainable school-based program to manage anxiety in elementary and middle school students with Autism Spectrum Disorder (ASD) and other special learning needs. There are two phases to this Department of Health and Human Services/Health Resources and Services Administration-funded research. In the first phase, there will be engagement of community partners in the process of developing the adapted intervention for implementation in schools. The first phase is ongoing until approximately fall of 2018. This project is the second phase of this program of research and is focused on piloting and implementing the school-based intervention within 3 local school districts in a systematic and sustainable way - through a "train-the-trainer" model. Primary aims are: 1. to prepare cross-disciplinary teams of School - Based Trainers to conduct three pilot student groups of Facing Your Fears - School Based (FYF-SB) within their own district, with the goal of later training others in their districts to deliver FYF-SB. 2. at the start of the following academic year (2019-2020), within each of the three participating districts, 10 schools will be randomized to one of two conditions for the fall semester: a) FYF-SB or b) Usual Care; and assess implementation and treatment outcomes.
The purpose of this study is to examine the use of, and reaction to, one particular software application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The hypothesis is that the use of these devices will increase engagement, motivation, interest, and have perceived benefits to users with unique attention-limiting cognitive disabilities. How does the observation of and user feedback from gameplay reveal areas of improvement for the game, strengths, and perceptions of value among the players and adults?
This study investigated the effects of a sensory diet intervention program on five children with a sensory processing disorder. The effect was investigated on children's sensory processing skills, psychosocial skills, and classroom engagement.
This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.
This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with special needs, this study aims to identify the psychosocial needs of parents of children with learning disabilities, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP). Phase II: Informed by Phase I findings, this study aims to develop and determine the feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP) program for parents of children with Specific Learning Disabilities (SPLD). Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial, establishing efficacy of a virtual resiliency program.
Children with explosive aggression are often rejected by their peers, placed in special classroom, and contribute to family discord. When psychotherapy and family therapy is unsuccessful, medications are often used. Current medications are stimulants (e.g. methylphenidate, dextroamphetamine), anticonvulsants (e.g. Divalproex) and antipsychotics (olanzapine, risperidone). At this time, the available medications are of limited usefulness, either because they do not always work or because they have side effects such as weight gain or insomnia. There is a clear need for new medications to treat explosive aggression when psychotherapy is unsuccessful. The hypothesis of this study is the medication Intuniv when combined with psychotherapy will be more helpful to children with explosive aggression than placebo combined with psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor is it an anticonvulsant, nor is it an antipsychotic. The children in this study will be between the ages of 6 and 12 and meet Diagnostic and Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for Intermittent Explosive Disorder.
The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.
The study team will conduct a mixed methods evaluation of the implementation of an evidence-based clinical program -- the Pediatric Complex Care Integration (PCCI) program - for improvement of care integration for children and youth with special healthcare needs (CYSHCN) and children with medical complexity (CMC). The PCCI program is not a discrete intervention itself; rather it is a health system-initiated program that will be implemented as a new standard of care for eligible patients with the intention of improving quality of care, implemented by clinical teams within Duke Health.