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Development Delay clinical trials

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NCT ID: NCT06412653 Not yet recruiting - Epilepsy Clinical Trials

Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders

ZINCGNAO1
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders. The main questions it aims to answer are: - Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy? - Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients. Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.

NCT ID: NCT06399952 Recruiting - Sleep Disorder Clinical Trials

Baker Gordon Syndrome Natural History Study

BAGOS
Start date: April 30, 2024
Phase:
Study type: Observational

The goal of this study is to conduct a prospective, longitudinal assessment of the natural clinical progression of children and adults with Synaptotagmin1-Associated Neurodevelopmental Disorder also known as Baker Gordon Syndrome (BAGOS). This will be performed by acquiring baseline measurements and developing effective outcome measures and diagnostic tools for the disorder, to prepare the healthcare system for future clinical trials.

NCT ID: NCT06314438 Completed - Autism Clinical Trials

Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are: - Is the Family Care Project workbook useful for families? - Is the Family Care Project workbook easy to use? - Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds? Participants will complete surveys that elicit their feedback on their use of the workbook.

NCT ID: NCT06263777 Completed - Clinical trials for Autism Spectrum Disorder

Early Detection of Children With Developmental Disabilities in Assiut Governorate

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

The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years).

NCT ID: NCT06229704 Not yet recruiting - Children, Only Clinical Trials

Vestibular and Postural Function in Children Suspected of Balance Disorders

VASIC
Start date: January 2025
Phase:
Study type: Observational

The goal of this prospective cohort study is to investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation. The main hypothesis of the study is that delayed gross motor development and symptoms of dizziness and balance problems in some children are caused by vestibular dysfunction. The investigators expect that early detection and rehabilitation by a physiotherapist will improve the balance ability for the child. The participants will be children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.

NCT ID: NCT06184243 Recruiting - Parents Clinical Trials

Home-Based Social Skills Intervention for Young Children With Developmental Delays

Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about how parent training can be used to teach a social skills intervention for their young child with developmental delays. Video modeling is a type of technology based intervention that teaches new skills using videos of someone acting out the behavior. The main questions it aims to answer are: - How well do the parent training procedures teach parents all the steps for using video modeling as a social skills intervention? - Do the children with developmental delays play and communicate more with their parents after the parent uses video modeling as a social skills intervention? Parent participants will be asked to participate in 3 interviews 30 min to 1 hour each, 2 in-home sessions 1 ½ to 2 hours each, 30 min Zoom sessions 2-3 times per week for 2-5 months Child participants will participate in 2 in-home sessions 1 ½ to 2 hours each and 30 min Zoom sessions 2-3 times per week for 2-5 months The time commitment is in ideal conditions, but will be impacted by other participants and parent schedules. The family will be committing to approximately 2-5 hours per week for 2-5 months. Sessions may occur as few as 0 or as many as 5 times per week. The hypothesis is that the parent training will teach parents all the steps to use video modeling intervention in their home with their young child with a disability. The second hypothesis is that the child with a disability will learn new social skills to play and communicate better in their home with their parent after watching the video models.

NCT ID: NCT05969808 Completed - Development Delay Clinical Trials

Effects of Adapted Physical Activities on Visual Motor Integration in Children With Developmental Delay

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

Developmental delay occurs when a child does not achieve developmental milestones in comparison to peers of the same age range. Children and adolescents with developmental delay often experience participation restrictions. Visual motor integration (VMI) is the ability of the child's hands and eyes to work together to guide their movements. Visual motor integration is a broad term encompasses cognitive as well as manual domains. This study will focused on the Manual Dexterity and intra-limb coordination (VMI). And it will evaluate the effects of adaptive physical activity on Visual Motor Integration. Adaptive physical activities (APAs) are exercises and games that have been specially designed to fulfil the unique needs and skills of special needs or developmental delays.

NCT ID: NCT05909670 Recruiting - Parenting Clinical Trials

FASTT Telehealth Behavioral Support Service for Caregivers of Children With Developmental Delay or Disability

FASTT
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

Over 7 million children in the U.S. receive support for a developmental delay or disability (DD). For caregivers of these children, behavior issues that often accompany their child's condition create high levels of stress leading to increased mental and physical health issues and impacts on caregiver-child interactions and family functioning. Although evidence-based practices exist to help caregivers with their child's behavioral development, access to these services is often limited by rigid delivery models requiring in-person visits that can delay support and further increase the burden on families. These barriers are disproportionately higher for families of color and for those in low resource situations: an effect that has been exacerbated by reductions in services due to coronavirus disease 2019 (COVID-19). The overall objective of this project is to develop and implement a telehealth delivery model of rapid-response, evidence-based behavioral support to be provided in conjunction with an existing family navigation program (Undivided) serving parents of children with DD to create a commercially marketable product that will reduce barriers to services in local communities across the country. This project will test the feasibility and acceptability of the Family Advice Text and Telephone (FASTT) support service for caregivers of young children. This Phase 1 application will enable a collaborative process to adapt evidence-based behavioral support to the specific needs of families of children ages birth to 12 with DD and integrate that support within the existing family navigation service. The rationale for the work is that providing effective, personalized support through the widely accessible mediums of text and telephone will get caregivers the help they need when and where they have time to access it and close in time to the behavioral issues they need help with, thus reducing caregiver stress and increasing their sense of competence and positive interactions with their child. Aim 1 determines the feasibility of delivering evidence-based behavioral support to caregivers of children with disabilities using on-demand text messaging. Aim 2 gauges the acceptability of the text-based support service to caregivers. Aim 3 assesses the extent to which text-based support reduces caregiver stress, improves caregiver sense of competence, and builds more positive perceptions of their child's behavior and their relationship with their child.

NCT ID: NCT05885113 Recruiting - Infant Development Clinical Trials

Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The proposed study includes a newborn developmental intervention to improve neurodevelopmental (ND) and medical outcomes for infants with congenital heart disease (CHD) with improved parent well-being. Literature documents long-term ND disabilities for children with CHD, caused by the negative effects of the hospital environment on the developing newborn brain. The cardiac intensive care unit (CICU), while necessary to save the life of the infant with CHD, exposes infants to overwhelming stress through painful procedures, invasive lines and tubes, toxic sensory stimulation, and separation from family. The combination of these negative experiences disrupts the infant's brain maturation and subsequent neurodevelopment. Individualized developmental care (IDC) is an intervention that minimizes the mismatch between infant neurobiological needs and the harsh hospital environment, thereby diminishing the frequency and severity of adverse effects. Core components of IDC include support for parent engagement, caregiving provided in a way to reduce infant stress, providing a soothing environment and appropriately positioning to enhance musculoskeletal and motor development. Research shows that IDC improves outcomes for preterm infants with enhanced brain structure and function, cognitive skills, executive functioning, behavioral outcomes, and family satisfaction from infancy to school age. Despite all the positive evidence for IDC, my past research showed most CICUs do not implement IDC due to lack of staff education and no evidence supporting IDC in CHD. The investigators propose the first randomized controlled trial to evaluate the efficacy of IDR as an intervention for children with CHD. The investigators hypothesize infants receiving IDC provided in the hospital, compared to those not receiving IDC, will show improved medical outcomes (including shorter hospital stay, improved oral feeding, increased growth), improved developmental competence, and increased parent coping at the time of discharge home and 3 months after discharge. With support from the Children's Heart Foundation, the investigators can demonstrate the feasibility and safety of implementing IDC in the CICU, the potential to improve the ND outcome for infants with CHD and increase parent well-being. This study would serve as the needed pilot study to request funding for a larger multicenter trial which would impact CICU care of infants with CHD and their families around the world.

NCT ID: NCT05803252 Recruiting - Clinical trials for Autism Spectrum Disorder

Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of SHCN Children

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The purpose of the proposed non-randomized waitlist-controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a Videoconferencing-based Individual Focused Acceptance and Commitment Therapy (FACT) approach to enhance the mental well-being of parents of children with special healthcare needs (SHCN) over a three-month period after the intervention has taken place.