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Developmental Delay clinical trials

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NCT ID: NCT06347666 Recruiting - Developmental Delay Clinical Trials

Coaching in Early Development Project

Start date: January 12, 2024
Phase: N/A
Study type: Interventional

Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff.

NCT ID: NCT06145659 Recruiting - Developmental Delay Clinical Trials

School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays

PreM
Start date: March 25, 2024
Phase: N/A
Study type: Interventional

This proposal aims to test whether a proposed community-clinical linkage (CCL), an educational-medical linkage model, improves access to school-based services and subsequent child, parent, family and health service outcomes and offers a promising strategy to address longstanding racial, ethnic and income health care disparities among families with preschool children with developmental delays and disabilities. The investigators designed an educational-clinical linkage model, Preschool and Me (PreM) which incorporates key components of a CCL. It also utilizes a personalized medical-education care plan with remote lay navigator support to increase access to school-based services.

NCT ID: NCT05749783 Recruiting - Developmental Delay Clinical Trials

Responsiveness of the Object Permanence Scale

Start date: February 1, 2023
Phase:
Study type: Observational

The aim of the study is the examining responsiveness of the Object Permanence Scale. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and 3 months. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.

NCT ID: NCT05749718 Recruiting - Developmental Delay Clinical Trials

Reliability and Validity of the Turkish Version of the Object Permanence Scale

Start date: February 1, 2023
Phase:
Study type: Observational

The aim of the study is the cultural adaptation of the Object Permanence Scale to Turkish and to examine its validity and reliability. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and after 1 week (retest). Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.

NCT ID: NCT05675371 Recruiting - Clinical trials for Autism Spectrum Disorder

Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children

MEASURE-ASD1
Start date: March 31, 2023
Phase:
Study type: Observational

The goal of this clinical study is to learn about the utility and performance of the EarliPoint(™) System: Evaluation for Autism Spectrum Disorder to monitor changes in a child's verbal ability, non-verbal learning, and social disability over time in children ages 15-84 months with autism spectrum disorder or related developmental delays (DD) and in those who are typically developing. The main questions it aims to answer are: - To estimate the change in each of the EarliPoint index scores in typically developing children ages 15-84 months from baseline through 180 days as a function of the child's age. - To estimate the change in the EarliPoint verbal and non-verbal index scores in ASD/DD children ages 15-84 months from baseline through 180 days as a function of the child's age in: a) those who showed clinical improvement, and b) those who did not show clinical improvement. - To estimate the relationship of the EarliPoint verbal and non-verbal index scores to clinical reference assessments in ASD/DD children as a function of their age from baseline through 180 days. - To estimate the degree of change, if change occurs, month-to-month in the EarliPoint Social Disability Index score from baseline through 180 days. - To estimate the incidence of behavioral events (e.g., tantrums, etc.) which limit the subject from completing an eye-tracking session. - To estimate the incidence of adverse device effects associated with the use of the study device.

NCT ID: NCT05527080 Recruiting - Child Development Clinical Trials

Development of Motility and Cognition in Infants

PILKE
Start date: October 1, 2021
Phase:
Study type: Observational

PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. In addition, PILKE studies correlation of early motor development to later neurocognitive development.

NCT ID: NCT05467527 Recruiting - Clinical trials for Autism Spectrum Disorder

PACT Programme for Parents of Children With SHCN

Start date: June 27, 2022
Phase: N/A
Study type: Interventional

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

NCT ID: NCT05418023 Recruiting - Clinical trials for Autism Spectrum Disorder

Validation of a Salivary miRNA Diagnostic Test for ASD

Start date: March 16, 2022
Phase:
Study type: Observational

This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. Participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. Children in the pediatric/provider setting who will receive a referral for an ASD diagnosis because they were determined to have a suspicion of developing ASD will be enrolled in the study. Children will also be enrolled in the specialist evaluation setting where they will receive a DSM-5 diagnosis. A subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered.

NCT ID: NCT04672967 Recruiting - Clinical trials for Autism Spectrum Disorder

MAP Autism Prediction Study

MAP
Start date: November 3, 2021
Phase:
Study type: Observational

This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the ages 18 and 60 months who have been referred to a developmental pediatric center for clinical evaluation of ASD or other developmental delay. Two selected sites will enroll 75 participants each with another 50 typically developing participants. Participants will receive a physical exam (including a dysmorphology evaluation), ADOS, VABS, MSEL, DSM-5, and M-CHAT assessments, and receive a diagnosis. A fasting blood draw is required, consisting of 2 mL vacutainer tubes (max 4 mL). Sites must process blood according to sponsor requirements (outlined in the Sponsor's Laboratory Manual). Certain metabolite levels in the blood will be used for diagnostic screening test development.

NCT ID: NCT04518332 Recruiting - Clinical trials for Postoperative Complications

Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.

rSO2-LDLT
Start date: September 1, 2020
Phase:
Study type: Observational

This rSO2 study is a prospective clinical study. The purpose of the rSO2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. This study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.