Tele-PCIT: Internet Delivered PCIT for Young Children with Neurodevelopmental Disorders

Date Added
December 11th, 2021
PRO Number
Pro00114624
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via tele-health for young children with a developmental diagnosis (ex. suspected or diagnosed autism, ADHD, global developmental delay, etc.) and disruptive behavior problems. Participants will go through a screening to determine eligibility. Once screening is complete, participants will complete a pre-therapy assessment in clinic, followed by 10 telehealth sessions one time per week, at no cost. Participants will then be asked to complete an in-person post-therapy assessment and follow-up questionnaires will be re-administered 3 months following the completion of therapy. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Jessie Montezuma
843-714-1352
autismresearch@musc.edu

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 24 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)

Date Added
January 4th, 2022
PRO Number
Pro00113213
Researcher
Ronald Teufel

List of Studies


Keywords
Infant, Infectious Diseases
Summary

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract. infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. Despite more than 50 years of attempted vaccine development, there are no licensed vaccines. While RSV prevention exists in the form of a specific RSV IgG (palivizumab) requiring 5 once monthly injections, it is licensed only for infants who experience the greatest morbidity and mortality from RSV: preterm infants born ≤ 35 weeks GA, children with chronic lung disease of prematurity, children with hemodynamically significant congenital heart disease. EDP-938 is a novel, orally administered, non-fusion replication inhibitor of respiratory syncytial virus (RSV) that is being developed as a potential treatment for RSV infection.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias

Date Added
March 11th, 2022
PRO Number
Pro00118800
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with leukemia. This study is called a screening study and we are doing this study to find better ways to diagnose and treat leukemia in children, adolescents and young adults. Bone marrow, blood, and medical information about participant's cancer and treatment will be collected. Participants can expect to be on this study for 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Impact of Disparities in Food Security on Glycemic Control and Health Care Utilization Among Youth and Young Adults with Diabetes 2

Date Added
November 30th, 2022
PRO Number
Pro00124480
Researcher
Angela Liese

List of Studies

Keywords
Diabetes
Summary

This study includes a longitudinal mixed methods study of 360 YYA with diabetes in SC, CO, and WA conducted with SFS 1 participants. SFS 2 will have two parts: (1) an intense, longitudinal study consisting of two 14-day assessment periods spaced 9 months apart which will include CGM, EMA, accelerometry, and surveys in all participants (the EMA study); and (2) a concurrent events qualitative study with a subset of participants (30 T1D, 15 T2D) who will complete 13 one-on-one, semi-structured interviews throughout the 9-month assessment period (the qualitative study).

Institution
USC
Recruitment Contact
Krystal Cooper
803-777-4485
hugheskp@mailbox.sc.edu

Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial

Date Added
April 4th, 2023
PRO Number
Pro00127137
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Minorities, Pain, Pediatrics, Rare Diseases
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms. 272 teens and adults with SCD will be enrolled in this study which is being conducted at the Medical University of South Carolina in Charleston SC., East Carolina University in Greenville NC., University of Miami in Miami FL., and the University of Alabama in Birmingham AL.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

Attention and Development in Infancy

Date Added
April 6th, 2023
PRO Number
Pro00127823
Researcher
Jessica Bradshaw

List of Studies

Keywords
Autism, Infant
Summary

Early intervention for infants and toddlers with or at an elevated likelihood for autism spectrum disorder can promote developmental skills and improve lifelong outcomes. Yet, many children with ASD are not diagnosed until after age 3. In order to improve early detection of ASD, we are investigating very early predictors of social communication challenges in infants as young as 1 week to 4 months of age.

This research study examines how the development of attention and motor skills in the first year of life is associated with the emergence of social and communication skills in three groups of infants: infants who are first born or who have a sibling with no developmental delays, infants who have an older sibling diagnosed with autism spectrum disorder, and infants who were born preterm.

Institution
USC
Recruitment Contact
Elizabeth Dixon
8039938356
esdlab@sc.edu

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Date Added
May 16th, 2023
PRO Number
Pro00128723
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer/Leukemia
Summary

This study is for patients with acute leukemia or myelodysplastic syndrome (MDS). This study is being done to help understand whether a haplo related donor or a MUD HCT for people with acute leukemia or MDS is better or if there is no difference at all.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

The impact of cannabis and tobacco/nicotine product co-use in young adults: Prospective cessation evaluation and substitution

Date Added
September 15th, 2023
PRO Number
Pro00131124
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Institution
MUSC
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)

Date Added
August 9th, 2024
PRO Number
Pro00135409
Researcher
Ronald Teufel

List of Studies


Keywords
Children's Health, Vaccine
Summary

Infants and young children are at increased risk for respiratory syncytial virus (RSV) infections because of their maturing immune system and lack of prior exposure to RSV. A genetically stable live-attenuated RSV vaccine (from the US National Institutes of Health) has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies. A Phase II study is ongoing to evaluate vaccine virus transmissibility to close contacts of study participants (VAD00014 study). Study VAD00004 will be initiated as part of the Phase III development of the RSVt vaccine. The objective of this study is RSVt clinical efficacy, while also further investigating the safety and immunogenicity of the RSVt vaccine in a global context. Vaccine efficacy against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be assessed separately, which will provide evidence of protection against RSV respiratory disease if efficacy against both LRTD and URTD is demonstrated.

Institution
MUSC
Recruitment Contact
Trudy Spuller
843-876-0000
pctg@musc.edu

Group Parenting Program for Managing Disruptive Behavior in Young Children

Date Added
September 8th, 2024
PRO Number
Pro00138994
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research is to assess a group-based telehealth parenting program for child ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based telehealth PCIT sessions, and an online post intervention assessment. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Alexandra Marsden
843-714-1352
autismresearch@musc.edu



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