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Intellectual Disability clinical trials

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NCT ID: NCT06371469 Not yet recruiting - Health Behavior Clinical Trials

Program of Health Behaviour Against to Cancer (PHeBAC)

PHeBAC
Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The European Code Against Cancer contains 12 recommendations to reduce the risk of cancer. It is estimated that about half of all cancers could be prevented if all recommendations are followed. The aim of this study was to evaluate the effectiveness of the Program of Health Behaviour Against Cancer (PHeBAC) applied to mothers of children with intellectual disabilities in increasing the participation of mothers and their children with intellectual disabilities in cancer screenings and their health behaviors against cancer. The goal is to improve the preventive health behaviors of children with intellectual disabilities and their mothers against cancer and to increase the rate of participation in cancer screenings. Specific targets are; not smoking and not being exposed to smoking, increasing physical activity, healthy nutrition, limiting alcohol consumption, protection from sunlight, HPV vaccination and increasing participation in breast, cervical and colorectal cancer screenings.

NCT ID: NCT06215235 Not yet recruiting - Depressive Symptoms Clinical Trials

Implementation of Bright Light Therapy ID

Start date: January 2024
Phase:
Study type: Observational

Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Earlier research has shown that BLT is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects. In part 1 of this project we investigate the implementation of BLT at Amarant. We will take the lessons learned into part 2 of this project: the implementation of BLT at Abrona. We will evaluate this process and the outcomes.

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: March 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.

NCT ID: NCT05290051 Not yet recruiting - Infertility Clinical Trials

Prospective Study to Assess Medical Performance of Optical Mapping and Long Read Sequencing in Detecting Numerical and Structural Chromosome Abnormalities. CHROmosome MAPping and Sequencing (CHROMAPS)

Start date: April 2022
Phase: N/A
Study type: Interventional

Chromosomal aberrations are major causes of developmental disorders (Intellectual disability (ID), multiple congenital anomalies (MCA), autism spectrum disorders (ASD)) as well as reproductive disorders (RD) in particular gametogenesis defects and recurrent miscarriages. Current first tier genetic investigations for chromosome analysis in clinical settings include karyotyping in case of RD (5 ~ 10% diagnosis rate) and chromosomal microarrays (CMA) in case of ID/MM (10 ~ 20% diagnosis rate). However, both assays show significant drawbacks, e.g. low resolution for karyotyping and inability to detect balanced structural rearrangement for CMA. Optical genome mapping and long read genome sequencing are emerging technologies that offer new opportunities to overcome these limitations and allow for a higher resolution chromosome analysis. This project aims at assessing the performance of optical mapping and long read whole genome sequencing compared to current gold standard cytogenetics methods in a prospective study. The investigator will evaluate their ability to become the all-in-one methodology for genomic analysis that could replace both karyotype and CMA and their added-value compared to these latter by uncovering new diagnoses.

NCT ID: NCT05174962 Not yet recruiting - General Population Clinical Trials

National Stigma Survey About Mental Illness, Intellectual Disability and Homelessness in Spain

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

This project is framed within the "Complutense University of Madrid (UCM)-Group 5 Against Stigma Chair", of the Faculty of Psychology. The main objective of the Chair is to fight the stigma that affects people with mental disorders, disabilities, vulnerability or extreme social exclusion. For this purpose, the Chair is developing research studies, training programs, cultural activities and awareness campaigns, proof of this is the recent publication of the Guide to good practices against stigma, which, although it takes as a reference to the people with a diagnosis of mental disorder, it is expected to be generalizable to other groups. Stigma is associated with the condition of being different, and affects any person belonging to a minority or vulnerable group, being one of the main obstacles to full participation in different social, political and cultural institutions. The fight against stigma is included in important international treaties, such as the United Nations Convention on the Rights of Persons with Disabilities or the European recommendations regarding the fight against social exclusion of people with mental health problems. This study will focus on three groups of special social sensitivity, with clear stigmatizing conditions: people with mental health problems, people in a homeless situation and people with intellectual disabilities.