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Early Intervention clinical trials

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NCT ID: NCT06361134 Completed - Infant Development Clinical Trials

Efficacy of Supporting SAFE Early Intervention

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.

NCT ID: NCT06080087 Active, not recruiting - Autism Clinical Trials

Implementation Toolkit to Enhance EBP Among Marginalized Families

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

Although the efficacy of early intervention (EI) for autistic children and their families has been established, many marginalized families with diverse cultural and linguistic backgrounds still report inequitable access to evidence-based practices (EBP). There are several strategies to increase EBP implementation that are especially relevant to marginalized families who report inequitable access to coaching from EI providers, such as increasing the capacity of EI providers to coach families in a culturally responsive way. However, EI providers are provided with limited professional development in both family coaching and cultural responsiveness, which results in perpetuation of EBP implementation failure. Thus, it is crucial to develop and validate an implementation toolkit that comprises strategies to enhance cultural responsiveness in the uptake of EBPs among EI providers. Therefore, the overall purpose of this research is to identify facilitators and barriers of EBP implementation among marginalized families in EI to aid the development an implementation toolkit with a focus on capacity building of EI providers to implement EBP with cultural responsiveness. This will involve conducting individual interviews with EI providers.

NCT ID: NCT05907109 Recruiting - Clinical trials for Congenital Heart Disease

NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil

Start date: March 16, 2021
Phase: N/A
Study type: Interventional

The objective of this randomized clinical trial is to test the effectiveness of a low-cost hybrid remotely monitored parent-mediated and clinic-based multidisciplinary early intervention (EI) for low-income infants with CHD in Brazil. The intervention protocols will be administered according to age modules, families will be monitored weekly. High risk infants also receive supplemental clinic-based interventions according to developmental needs. Controls will receive standard of care and access to early child development and nutrition practices information from the Brazilian Ministry of Health. All infants will be evaluated at within a 42-month follow-up research outpatient clinic, called NeuroCardio Baby at Santo Antonio Pediatric Hospital, of the Santa Casa de Misericordia Hospital Complex, and affiliated with The Cardiology Institute-University Foundation of Cardiology (IC-FUC), Porto Alegre, Brazil.

NCT ID: NCT05880238 Completed - Early Intervention Clinical Trials

The Effect of Sensory Motor Training in Preschool Children

Start date: May 17, 2023
Phase: N/A
Study type: Interventional

When looking at the literature, sensory-motor skills, self-regulation, executive functions, cognitive styles, and school readiness are strongly related concepts. Self-regulation skills are closely related to the maturity of sensory-motor components. Therefore, it is important to provide sensory-motor training with self-regulation strategies. However, no study investigating the effects of self-regulation strategies combined with sensory-motor training on school readiness, self-regulation, executive functions, and cognitive styles could be found in the literature. Our study aims to examine the effect of self-regulation strategies and occupational therapy-based sensory-motor training on self-regulation, cognitive skills, and school readiness in preschool children. The research will be carried out in two preschool classrooms of students aged 5-6 years registered for the 2022-2023 academic year at Özel Mavi Umut Eğitim Kurumları in Istanbul. A total of 38 children will participate in the study, 19 in the intervention group and 19 in the control group. While the control group continues their preschool education, the intervention group will receive group interventions including self-regulation strategies and sensory-motor skills training for 1 hour, twice a week, for 10 weeks, in addition to their regular preschool education. Metropolitan School Readiness Test, Kansas Pre-School Self-Concept Scale Form A, Childhood Executive Function Inventory, Pre-School Self-Regulation Scale, Dunn Sensory Profile, and Bruininks-Oseretsky Short Form 2 will use to evaluate both the intervention and control groups at 10-week intervals. The data obtained from the evaluations will be analyzed using SPSS (Statistical Package for Social Science) 22.0 version. If the data follows a normal distribution, the Paired Student's t-test will be used for comparison, and if not, the Wilcoxon Matched Two-Sample Test will be used. Mean±standard deviation (X±SD) will be determined for the identified variables. A statistical significance level of p≤0.05 will be considered.

NCT ID: NCT05614206 Recruiting - Clinical trials for Autism Spectrum Disorder

Biomarkers Trajectories of Early Intervention in Siblings of Children With Autism Spectrum Disorder

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

This project deals with essential challenges in the context of Autism Spectrum Disorder benefiting from a prospective design in childhood, early intervention and a cutting-edge experimental techniques. The present study tests the potential effect of early intervention on neural and behavioral responses in toddlers at elevated likelihood of developing autism (siblings of children with autism) who show clinical autistic signs. Four comparison groups were included in the study: (1) toddlers at elevated likelihood of developing autism with clinical autistic signs who receive early intervention from 18 to 24 months (2) toddlers at elevated likelihood of developing autism with clinical autistic signs who do not receive early intervention (3) toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring, and (4) typically developing toddlers who only received assessment and monitoring. This study focuses on social and nonsocial sensory integration skills (measured by electroencephalographic and eyetracking recordings) to identify reliable biomarkers for early detection and intervention of autism during a critical period of development. The characterization of biomarkers will guide the detection of the most vulnerable children that will benefit from early intervention, with the long-term aim of reducing the impact of autism on the National Health System.

NCT ID: NCT05399667 Active, not recruiting - Preterm Birth Clinical Trials

Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program

Start date: January 31, 2020
Phase:
Study type: Observational

This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program. The preterm-born children participated in the project entitle "Early Intervention Program for Preterm Infants and Their Parents: establishing the impact at 18 Months Corrected Age" (NCT02835612), which performed a continuous early stimulation in very and extremely preterm infant's families in their first 12 to 18 months. In the present study, preterm born children currently with 3 to 6 years old and their mothers (or legal guardian) are once more invited to a one-day visit for a nutritional and clinical evaluation at the Clinical Research Center of Hospital de Clínicas de Porto Alegre/Brazil. In the consultation, preterm born children and theirs mothers are submitted to the following exams: body composition by electrical bioimpedance, clinical and physical evaluation, anthropometric measurements, and children's eating habits, eating behavior and parental educational style in food through specific questionnaires. Moreover, this study will also investigate a group of pre-scholar health children born at term to obtain reference values for variables analysed. The goal with these findings is to determine if an early stimulation program could present a positive impact in anthropometric outcomes and nutritional aspects in this more vulnerable preterm born population.

NCT ID: NCT05334550 Not yet recruiting - Parents Clinical Trials

Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent

Start date: June 2, 2022
Phase: N/A
Study type: Interventional

This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.

NCT ID: NCT05333224 Recruiting - Early Intervention Clinical Trials

Effectiveness of Telerehabilitation in High Risk of Infants

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

While the mortality rate in preterm births has decreased thanks to recent developments in the field of medicine, disability risk factors increase for premature babies. Premature birth, low birth weight, and all accompanying problems in this process reveal the concept of the risky baby. Early intervention is very important for these babies who are at risk for neurodevelopmental problems. Although early intervention is a general concept, the subject the investigators focus on is early physiotherapy approaches. Early physiotherapy approaches include many methods. However, recently, family-centered approaches have been emphasized and studies have been carried out on this issue; Likewise, the goal-oriented therapy approach, which is a treatment with a high level of evidence, is also being investigated. Telerehabilitation, on the other hand, has become a method that is frequently used with the increase in the use of technological methods. The effectiveness of family-centered, goal-oriented physiotherapy approaches is known in previous studies on this subject; There are studies conducted on a remotely monitored portable intelligent system created for telerehabilitation, but no studies have been found in which telerehabilitation has been applied using the real-time video conferencing method. It has also been reported in the literature that the development of risky infants is affected by factors such as the education level of families, their economic status, mental health, perceived support level, and the mother-infant relationship.

NCT ID: NCT04783220 Recruiting - Early Intervention Clinical Trials

PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)

PREPARE
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.

NCT ID: NCT04759573 Recruiting - Prematurity Clinical Trials

Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit

EVC
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Background: Preterm infants are at risk for developing altered trajectories of cognitive, social, and linguistic competences compared to a term population. This is mainly due to medical and environmental factors, as they are exposed to an atypical auditory environment and, simultaneously, to long periods of early separation from their parents. The short-term effects of Early Vocal Contact (EVC) on an infant's early stability have been investigated, but currently, there is limited evidence of its impact on the infant's autonomic nervous system maturation, as indexed by the heart rate variability, as well as on its long-term impact on infant neurodevelopment. This multi-centric study aims to investigate the effects of EVC on a preterm infant's physiology, neurobehaviour, and development. Methods: Eighty stable preterm infants, born at 25 to 32 weeks and 6 days gestational age, without specific abnormalities, will be selected and randomized to either an intervention or a control group. The intervention group will receive EVC: mothers talking and singing to their preterm infants for 10 minutes thrice a week for 2 weeks. Mothers in the control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviour through a standard cluster of indicators. Infants will be assessed at baseline, at the end of the intervention, at term equivalent age, and at 3, 6, 12- and 24-months corrected age, with a battery of physiological, neurobehavioral, and developmental measures. Discussion: Early interventions in the neonatal intensive care unit have shown important effects on the neurodevelopment of preterm infants, lowering the negative long-term effects of an atypical auditory and interactional environment. This study will provide new insights into the mother-infant early contact as protective intervention against the sequelae of prematurity during the sensitive period of development. An early intervention, such as EVC, is intuitive and easy to implement in the daily care of preterm infants. However, its long-term effects on infant neurodevelopment and on maternal sensitivity and stress still need accurate investigations.