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Intellectual Disability clinical trials

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NCT ID: NCT06465641 Not yet recruiting - Clinical trials for ADHD - Combined Type

Methylphenidate in KBG Syndrome: N-of-1 Series

KBGS_N_of_1
Start date: September 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial] is to learn about the effect of methylphenidate in children and adolescents with KBG syndrome. The main question it aims to answer is: • What is the effectiveness of methylphenidate on attention deficit and ADHD-related symptoms in children and adolescents with KBG syndrome? Participants will receive multiple blocks of treatment with methylphenidate and placebo and fill out various questionnaires.

NCT ID: NCT06444659 Not yet recruiting - Clinical trials for Intellectual Disability

Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilitiesdisability

Start date: June 2024
Phase: N/A
Study type: Interventional

The object of this study is the theory and practice of adaptive physical activity for people with intellectual disability. It focuses on the concepts, paths, and applications of adaptive physical activities for young people with intellectual disability, and systematically studies and discusses the concepts, paths, and application strategies of adaptive physical activities for young people with intellectual disability, so as to provide solutions and support for the scientific exercise of this special population group. The study will focus on the following four aspects: (1) theoretical research on the interventions of young people with intellectual disability (2) analysis of the sports and health needs of young people with intellectual disability (3) empirical research on adaptive physical activities for young people with intellectual disability (4) exploration of strategies for the use of adaptive physical activities. Based on theoretical and practical research, to understand the current situation of sports participation and influencing factors of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability , to provide a reliable basis for the formulation of adaptive sports activity programmes suitable for the rehabilitation concepts of the Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability; to increase the interest of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability in sports activities, so as to enable them to master the basic sports skills, have the physical abilities required for completing the basic social activities, and be able to participate in sports activities on a regular basis in their future lives; and to promote their physical health and happy lives, with a view to facilitating their integration into regular education and, ultimately, social integration.

NCT ID: NCT06403969 Not yet recruiting - Insomnia Clinical Trials

Sleep in Children With Autism and Intellectual Disability

SLEEP-AID IT
Start date: May 14, 2024
Phase: N/A
Study type: Interventional

Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied Behavior Analysis (ABA) for insomnia, focusing on sleep maintenance difficulties, in these children. Method: Single-case experimental design with multiple baselines and with multiple participants, with a focus on feasibility. N=15 prepubertal children, aged 6-12 years, with autism and intellectual disabilities combined, and difficulties in maintaining nighttime sleep. Assessment with home polysomnography + actigraphy. Intervention with ABA, including functional analysis, measurable goals, and behavior modification based on the functional analysis. Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment. Feasibility is examined as adherence to assessment and treatment, as well as in a qualitative study of parental experiences.

NCT ID: NCT06392113 Not yet recruiting - Fall Clinical Trials

Developing a Falls Management Tool for Adults With ID-POC

Start date: July 2024
Phase:
Study type: Observational

Falls can have a significant impact on the lives of adults with intellectual disabilities. The ACTION FALLS programme is a systematic falls management intervention that has been shown to be of benefit for older people however this programme in its current form needs to be adapted for use with adults with intellectual disabilities who have specific risk factors for falling and specific actions to reduce these risks. An adapted version of the programme to account for the different needs of adults with intellectual disabilities and the different services and support networks they access will be developed. A draft programme has been developed based on the views of adults with learning disabilities, carers and clinicians. This programme will now be tried out to see how easy it is to use and whether it can identify the falls risk factors relevant to adults with learning disabilities. Adults with an intellectual disability, clinicians and carers will t try out the programme and will be observed using it and will be asked to give verbal feedback on their views on how easy it is to complete and what could be improved.

NCT ID: NCT06112483 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

SWELE Program: An Unstructured Outdoor Play With Mindfulness-based Interventions to Promote Mental Health Among Students With Special Education Needs

SEN
Start date: November 15, 2023
Phase:
Study type: Observational

This is an observational study with the aim of SWELE Programme is to raise mental health knowledge and awareness by implementing a play-based approach on Supporting Wellness in E-Child Learning Environments (SWELE) programme combining unstructured outdoor play activities with mindfulness-based interventions to promote mental health in children and adolescents with special education needs (SEN), in the context of the COVID-19 pandemic. This is a 16-week SWELE programme and it will be conducted in two batches. Each batch has three special schools. The main activities include: One training workshop for three groups in each special school: 1) Scout Leaders (special schools' teachers), 2) SEN students (scouts in the school) to become Youth Mental Health Ambassadors and 3) for parents, school social workers, school nurses, schoolteachers and stakeholders; 30 minutes unstructured outdoor play with mindfulness activities 2 times per week for 16 weeks After participated the SWELE programme, the primary outcomes include reducing anxiety symptoms, reducing negative emotions, improving social skills in peer relationships; and changing in playfulness level among SEN children and adolescents. Main activities of SWELE programme: - Unstructured outdoor free play integrated into the school's extra-curricular activities (Youth Mental Health Ambassadors) to promote SEN students' mental health for objectives 1-4. - Use mindfulness-based podcasts, mindfulness games, mindfulness art for objectives 1-2. - Through meditation and deep breathing technique, storytelling with relaxing waves piano music, yoga and mindful art for objectives 1-2. - Training Workshops (Training of trainers) for Scout Leaders who will implement SWELE program in each special school. - Youth Mental Health Ambassador Program for SEN students who are enrolled in Scout Club in each special school; SWELE training workshops for parents and schoolteachers will also be held in each special school for objectives 1-4. - Examples of unstructured play might be creative play alone or with others, including artistic or musical games. imaginative games - for example, making cubbyhouses with boxes or blankets, dressing up or playing make-believe, exploring new or favorite spaces like school backyards, parks, playgrounds and so on.

NCT ID: NCT06107829 Not yet recruiting - Clinical trials for Intellectual Disability

Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities

TD-AIDD
Start date: August 2024
Phase: Phase 4
Study type: Interventional

The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are: - Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD? - Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD? - Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine? - Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD? - Does valbenazine treatment of TD in persons with IDD reduce caregiver burden? In this study, 25 participants with IDD and TD will undergo valbenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.

NCT ID: NCT06063239 Not yet recruiting - Clinical trials for Intellectual Disability

Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to test the effect orally administration of Probiotics based on Lactobacillus rhamnosus LR04 and Lactobacillus plantarum LP14 as adjuvant in caries prevention in subjects who can not properly perform oral hygiene procedures. The main questions it aims to answer are: - QUESTION 1: orally administered probiotics based on the previous strains could represent a useful tool in support of special needs patients in tooth decay prevention? - QUESTION 2: orally administered probiotics based on the previous strains could ameliorate salivary pH management? Partecipants in the test group will take the test probiotic for 90 days in adjunction of the routinary oral hygiene procedures. Partecipants in the positive controlled group will take the placebo for 90 days in adjunction of the routinary oral hygiene procedures. Partecipants in the negative control group will perform only the routinary oral hygiene procedures. Researchers will compare 3 groups to see if orally administered probiotics based on L. rhamnosus and L. plantarum may help in the management of clinical status and salivary pH levels.

NCT ID: NCT05864508 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.

OT-DEFI
Start date: July 2023
Phase: Phase 2
Study type: Interventional

The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.

NCT ID: NCT05473377 Not yet recruiting - Clinical trials for Intellectual Disability

Computerized Testing System for Measuring Motor and Sensory Integrative Functions in Intellectual Disabilities

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Assessment of the motor and sensory integrative functions (MSI) is a key component of an overall health and functional evaluation for school-aged children with intellectual disabilities (ID). An efficient and in-depth understanding of the students' motor and sensory integrative functions can help the school teachers implementing appropriate curriculum, monitoring the progress, managing the classroom, and further enhancing the overall learning for school-aged students with ID. Therefore, in this 2-year project, the investigators will develop a mobile application (APP) testing system for assessing Motor and Sensory Integrative Functions in School-aged Children with Intellectual Disabilities (MSI-ID) to overcome the aforementioned challenges. The investigators will determine whether the MSI-ID is efficient and psychometrically robust. Around150 to 200 school-aged children with ID will be recruited for this study.

NCT ID: NCT05442229 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

A Cross-sectional Study to Evaluate Speech and Language Development in Chinese Children Aged 2-6 Years

Start date: July 1, 2022
Phase:
Study type: Observational

The purpose of this study is to establish a new Chinese children's speech and language norm by obtaining the latest data of speech and language development of children aged 2 ~ 6 from different regions in China. At the same time, the overall development level and group differences of speech and language in Chinese children aged 2 to 6 years, and the influencing factors of speech and language development in Chinese children aged 2 to 6 years were also discussed.