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Developmental Delay clinical trials

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NCT ID: NCT02712853 Completed - Clinical trials for Autism Spectrum Disorder

Improving Autism Screening With Brain-Related miRNA

Start date: November 2015
Phase:
Study type: Observational

The goal of this project is to identify specific miRNAs that are increased or decreased in the saliva of children with developmental delay and are useful for screening toddlers for ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals to developmental specialists, and expedite the arrangement of early intervention services.

NCT ID: NCT02699814 Completed - Clinical trials for Mental Health Disorder

H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation

H3
Start date: March 2016
Phase: N/A
Study type: Interventional

The goal of this project is to develop and pilot test a community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems that is replicable, effective, and sustainable. Project procedures include child mental health screening, on-site brief mental health interventions, referral to specialty mental health, use of co-located child psychiatrist, detection of need for primary care in specialty mental health program. Subjects will be enrolled for 1 year, with interviews at baseline and 3, 6 and 12 months. Dr. Bonnie Zima at UCLA has been contracted by the project funder to design and implement the evaluation of the project, which includes developing data collection procedures, training staff on implementation of data collection workflow, coordinating with sites to ensure evaluation design and IRB protocols are followed, and coordinating with both study sites to verify data reliability. Some potential anticipated risks include being uncomfortable answering questions associated with the measures used in the study, and although unlikely, someone may access participant information that is confidential. Some benefits include helping to find ways to improve how to deliver mental health care for children served in publicly-funded primary care and mental health clinics.

NCT ID: NCT02633241 Completed - Epilepsy Clinical Trials

A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

Start date: March 2, 2017
Phase: Phase 4
Study type: Interventional

This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI. The investigators studied three arms to examine the effectiveness of dexmedetomidine. Arm 1 was a single bolus of 1.0 mcg/kg with 1.0 mcg/kg/hr infusion followed by propofol infusion. Arm 2 was a bolus of 1.0 mcg/kg with 0.5 mcg/kg/hr infusion followed by propofol infusion. Arm 3 was only a single bolus of 1.0 mcg/kg with no infusion followed by propofol infusion.

NCT ID: NCT02593825 Completed - Cerebral Palsy Clinical Trials

Efficacy of the START-Play Program for Infants With Neuromotor Disorders

START-Play
Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.

NCT ID: NCT02414438 Completed - Clinical trials for Intellectual Disability

Establishing the Clinical Utility of First StepDx PLUS and NextStepDx PLUS Study

Start date: August 2014
Phase: N/A
Study type: Interventional

The study uses a randomized controlled study design of pediatric neurologists and developmental pediatricians and front-line (primary care) pediatricians to determine if use of FirstStepDx PLUS and Next StepDx PLUS are associated with higher clinical quality, less variability in clinical practice, and lower costs from decreased resource utilization. The Clinical Performance and Value Vignettes (CPV) used in this study simulate a clinical encounter for individuals with an atypical phenotype and clinical presentation indicative of a possible genetic disorder. We will measure the difference in combined diagnostic and treatment CPV® domain score post-intervention versus baseline comparing intervention and control groups

NCT ID: NCT02396576 Completed - Depression Clinical Trials

Using Telehealth to Deliver Mental Health Services in Primary Care Settings for Children in Underserved Areas

Start date: April 7, 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02141802 Completed - Cerebral Palsy Clinical Trials

Clinical Effectiveness of Increased Standing Time in Non-ambulant Children With Cerebral Palsy:a Pilot Study

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

Children with cerebral palsy commonly use standing frames to position them to help prevent contracture and deformity and to help their function. There is a lack of evidence to support the correct dosage of standing frame use. The aim of this study is to pilot a randomised controlled trial of the clinical effects of doubling the duration of standing, using standing frames, in young children who are unable to walk, who have cerebral palsy or developmental delay. It will determine whether it is feasable to carry out a multi-centred trial. The study objectives will be to determine: 1. presence of adverse events 2. recruitment and drop out rate 3. compliance with the intervention 4. feasibility of the randomisation and minimisation process 5. the proportion of the outcome measures taken 6. effect size estimate 7. required study costs 8. effectiveness of blinding procedure

NCT ID: NCT02115334 Completed - Developmental Delay Clinical Trials

Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay

Start date: May 2011
Phase: N/A
Study type: Interventional

Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.

NCT ID: NCT01975506 Completed - Developmental Delay Clinical Trials

Occupational Therapy in the Context of Head Start

Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to identify the role of occupational therapy within Head Start programs. Representatives within Head Start will be asked to participate in a nationwide internet based survey identifying the amount and type of services provided within this area. The Model of Human Occupation (MOHO) will also be included in the study by identifying current use of the model and how it can be utilized in the future. In order to complete this study to the fullest extent, we must begin by defining the Model of Human Occupation as well as understanding the mission of the National Head Start Association. The vision of MOHO is to support practice that is focused on occupation, client centered, holistic, evidence-based, and complementary to other occupational therapy models. The mission of the National Head Start Association is to coalesce, inspire and support the Head Start field as a leader in early childhood development and education. This has lead researchers to perform the following study: An examination of occupational therapy in the context of Head Start.

NCT ID: NCT01660958 Completed - Developmental Delay Clinical Trials

Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India

GrowSmart
Start date: August 2012
Phase: N/A
Study type: Interventional

Project Grow Smart evaluates the impact fortification with multiple micronutrient powders (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient status, growth, and morbidity (secondary outcomes) among young children in rural India (Nalgonda district of Telegana). There is an infant phase and a preschool phase; investigators, study team members, and participants are unaware of whether the fortification is MNP vs. placebo. The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP vs. placebo and early learning vs. routine care), conducted through home visits. Sachets (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are: 1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads to better development; 3) Integrated MNP plus early learning leads to better development through both additive and synergistic processes. Developmental evaluations and anthropometric measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood draws for micronutrient status are performed at baseline and endline. Morbidity measures are collected monthly using a morbidity form, modeled after the Demographic and Health Survey. The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC) (preschools). AWC are classified as high or low stimulation, based on an objective observational rating system of the physical environment of the preschools and teacher-child interactions. Preschools are categorized into high/low-quality based on median split, followed by random assignment of MNP/placebo nested within high/low-quality preschools. The hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The intervention has been modified to coincide with the academic term (September-May). Evaluations are conducted at baseline (September) and end-line (prior to May), with an 8-month intervention period.