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Intellectual Disability clinical trials

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NCT ID: NCT06160102 Active, not recruiting - Clinical trials for Disability, Developmental

Safe Drug Use in People With Intellectual and/or Developmental Disabilities - it Applies to Life

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

The innovation idea is to develop valuable new knowledge about safe drug use in people with intellectual and/or developmental disabilities (IDDs). The main goal is to design a framework (routines and processes) that ensures safe drug use and provides qualitatively better services for people with IDDs. Secondary goals are that employees will experience better security when working with medicines, and interact better with people with IDD and relatives by implementing digital support functions. The innovation idea is specifically to develop/improve the following: 1) Medication management: Coordinating routines, procedures and work processes regarding all aspects of drug use, medication handling, and communication between care units for people with IDDs. 2) Medication therapy: Chart review of prescribed medication and gather knowledge about challenges related to drug use in this group. Based on this, we will develop new methods for drug reconciliation and medication reviews to optimize drug use. 3) New framework for safe drug use in the community-based services for people with IDDs.

NCT ID: NCT06156124 Recruiting - Diabetes Clinical Trials

The Role of Family and Individual Factors in Going Through Adolescence - Perspective of a Healthy Child.

Start date: June 13, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate the specificity of the growing up process in young people with disabled siblings. The functioning of adolescents with disabled siblings as a person growing up in three environments will be examined: family, peers and school. The main questions it aims to answer are: - Does having a disabled sibling influence the functioning of a healthy child in the family system? - Do siblings of disabled children show a higher level of maturity than their peers with properly developing siblings? - Does having a disabled sibling modify a child's functioning among peers? - Does having a disabled sibling modify healthy adolescent's educational experience? - Is there a greater risk of psychological disorders among siblings of disabled children than among siblings of normally developing children? The 160 participants' dyads will take part in the study: healthy adolescent having disabled sibling and one of his/her parents. The parents' participation is necessary to assess the presence of possible internalizing and externalizing disorders among adolescents taking part in the study. The healthy adolescent will be filling out questionnaires regarding the remaining studied variables: functioning in the family - siblings relations, parental attitudes; at school - school achievement, extracurricular activities; relations with peers - time spending with peers, number of friends, as well as the growing up process trajectory - parentification and the way of going through an adolescent crisis. Researchers will compare four groups (40 dyads in each group): three groups of adolescents having disabled sibling 1) intellectual disability, 2) motor disability, 3) chronic somatic disease, and 4) control group - healthy adolescent having sibling without any disability, to see if they differ from each other referring to the studied variables.

NCT ID: NCT06120686 Recruiting - Clinical trials for Intellectual Disability, Mild

Biofeedback Training's Impact on Cognitive and Motor Skills in Kids With Intellectual Disabilities

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

The expected outcome of the study is to confirm or reject the hypothesis that traditional rehabilitation in combined with biofeedback training produces better results in improving motor and cognitive functions, relative to conventional rehabilitation. In addition, the result of the study will be a protocol for dealing with school-aged children school-age children with impaired motor functions associated with impaired cognitive functions. The developed material, will be a practical addition to therapeutic programs, Particularly useful in the work of psychological and pedagogical clinics, in offices of rehabilitation and sensory integration offices, or centers implementing early childhood development supporting child development.

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: NCT06097819 Completed - Clinical trials for Intellectual Disability

Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities

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

Individuals with intellectual disabilities face challenges in areas of attention, motor skills, and awareness. Among the problems they experience are difficulties in focusing, transitioning from one activity to another, performing tasks in sequence in skills such as copying, reading, and writing. Additionally, they tend to form sentences with misarranged words. Generally, they may present with disorganized or weak handwriting. Other reported issues in this population include coordination problems in extremities and balance disturbances. These essential life skills can impede the individual's ability to move safely. With the recent integration of technology into rehabilitation, new intervention and assessment methods have emerged for occupational therapists. Systems like Microsoft Kinect, Nintendo Wii, Xbox, and Leap Motion are being used in these methods. In the literature, Kwok et al. included 73 participants aged between 60-85 in their study. They examined the connection between swinging speeds while standing on both feet on a balance board and the risk of falling. They concluded that the anterior-posterior swing speed measure derived from the Wii Balance Board (WBB) could complement current clinic-based measurements in predicting future falls among community-dwelling older adults. Reviewing the literature, technological rehabilitation applications are observed to be used in various patient groups. However, studies on occupational therapy-based technological rehabilitation interventions in individuals with intellectual disabilities are limited. To our knowledge, there isn't a study evaluating awareness, cognitive, and physical skills in intellectually disabled individuals using Leapmotion, Xbox, Balanceboard sensors, and mobile games. Based on this information, the aim of our study is to investigate the effects of occupational therapy-based rehabilitative games on motor skills, proprioception, and cognitive functions in individuals with intellectual disabilities.

NCT ID: NCT06086951 Recruiting - Clinical trials for Autism Spectrum Disorder

Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT

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

Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Leveraging previous evidence from our team's research, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT incorporates the counselling logic of Acceptance and Commitment Therapy (ACT) through natural language processing, enabling parents to engage in human-like voice-to-text conversations and receive assessments and stepped-care mental health interventions, including guided self-help materials and real-time, individual-based counselling based on ACT. Following the research and development phases, we aim to kick off the utilisation of Pai.ACT by (1) pilot-testing its feasibility, acceptability, and potential efficacy in improving mental health outcomes for parents of children with special needs and (2) researching to determine the most optimal service model for parents by exploring their perceptions through focus group interviews. Pai.ACT offers accessible and comprehensive mental health services to all Chinese-speaking parents, addressing their psychological burden in caring for children with special needs. Pai.ACT could bring substantial and enduring societal benefits to Chinese-speaking families by integrating mental health support services for family caregivers with current child rehabilitation services and non-governmental organisations. Furthermore, this could contribute to reducing the public stigma attached to special needs children while increasing mental health awareness.

NCT ID: NCT06065527 Recruiting - Clinical trials for Intellectual Disability

Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers

Start date: December 22, 2023
Phase: N/A
Study type: Interventional

This study will compare the effectiveness of a web-based long-term care planning tool (Map Our Life) partnered with traditional case management services to traditional case management services partnered with an attention-control Centers for Disease Control and Prevention (CDC) sponsored website on health promotion for people with disabilities. The goal of this clinical trial is to promote long-term care (LTC) knowledge and planning among individuals with intellectual/developmental disabilities (IDD) and their family caregivers to improve social supports, health, and quality of life outcomes.

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: NCT06032455 Recruiting - Clinical trials for Behavioural Problems

Effectiveness of Multisystemic Therapy for Adolescents From Families With Intellectual Disabilities

Start date: September 4, 2023
Phase:
Study type: Observational

The goal of this observational study is to determine the effectiveness of a specialisation of multisystemic therapy (MST) for adolescents with severe behavioural problems from families with an intellectual disability (ID; MST-ID). To achieve this goal, a mixed method study design is used. To this end, a quantitative and a qualitatively primary research question are formulated: - Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents (quantitative)? - What are the experiences of adolescents and/or parents receiving MST-ID treatment (qualitative)? Participants will be asked to complete two screeners (questionnaires delivered as a verbal interview) with a total duration of approximately 30 minutes. Other data will be collected through Routine Outcome Monitoring questionnaires that are part of standard MST procedures. To this end, five 'time points' have been identified: T0 (start of MST[-ID] treatment), T1 (end of MST[-ID] treatment), T2 (follow-up 6 month after MST[-ID] treatment), T3 (follow-up 12 month after MST[-ID] treatment), and T4 (follow-up 18 month after MST[-ID] treatment). The qualitative method used to gain insight into families' experiences is determined in consultation with the families. To assess the effectiveness of MST-ID, its treatment outcomes will be compared to standard MST treatment outcomes of families with ID.