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Intellectual Disability clinical trials

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NCT ID: NCT04418752 Withdrawn - PTSD Clinical Trials

Narrative Exposure Therapy for Adults With Intellectual Disability

Start date: June 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to identify how Narrative Exposure Therapy (NET) can be adapted for delivery with adults with mild Intellectual Disability (ID) and to explore whether NET can reduce symptoms of traumatic stress in this population. The first phase of the research involves working with a speech and language therapist to make adaptations to the therapy and research materials for adults with mild ID. This work will then be triangulated by gaining feedback from a service user focus group on the accessibility of materials for adults with mild ID. The second phase of the research consists of a 'sequential measurement single case studies series' to explore the effectiveness of Narrative Exposure Therapy (NET) in reducing symptoms of PTSD or prominent symptoms. Questionnaires will be completed before, during and after the therapy by both the adult with ID and a carer if possible and consenting. Electrodermal activity of participants will be measured throughout sessions (using an unobtrusive device) as an indicator of physiological arousal. All measures will be visually analysed using established criteria and statistical methods where possible. The impact of NET on a person's memory of events in their life will be explored by examining how coherent participants' accounts of traumatic experiences are before and after NET using coding systems developed by previous studies. An interview will take place approximately six weeks after therapy with the participant by an independent researcher. This will aim to collect qualitative data about the participants' experiences of NET and will be analysed using content analysis. Participants will be recruited primarily from Intellectual Disability services in Nottinghamshire Healthcare NHS Foundation Trust. This will be extended to Derbyshire Healthcare NHS Foundation Trust and Lincolnshire Partnership NHS Foundation Trust if necessary (Secondary care). The investigators intend to recruit six participants and six carers to the study.

NCT ID: NCT04395495 Recruiting - Neurofibromatosis 1 Clinical Trials

RASopathy Biorepository

Start date: June 27, 2017
Phase:
Study type: Observational [Patient Registry]

The RASopathies are a group of developmental disorders caused by genetic changes in the genes that compose the Ras/mitogen activated protein kinase (MAPK) pathway. New RASopathies are being diagnosed frequently. This pathway is essential in the regulation of the cell cycle and the determination of cell function. Thus, appropriate function of this pathway is critical to normal development. Each syndrome in this group of disorders has unique phenotypic features, but there are many overlapping features including facial features, heart defects, cutaneous abnormalities, cognitive delays, and a predisposition to malignancies. This research study proposes to collect and store human bio-specimens from patients with suspected or diagnosed RASopathies. Once obtained, blood and/or tissue samples will be processed for: metabolic function studies, biomarkers, genetic studies, and/or the establishment of immortalized cell lines. In addition, data from the medical record (including neuropsychological evaluations) and surveys will be stored to create a longitudinal database for research conducted at CCHMC or at other research institutions.

NCT ID: NCT04382573 Recruiting - Clinical trials for Congenital Heart Defects

Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.

CDK13
Start date: November 1, 2019
Phase:
Study type: Observational

CDK13 related disorder is mainly characterised by developmental delay (DD) and intellectual disability (ID), ranging from mild to severe, and malformation syndrome. The aims of this study are first to better delineate the clinical phenotype, as well as the neuropsychological profile, and the brain MRI characteristics; and, second, to study the epigenetic signatures in a cohort of individuals with CDK13 intragenic pathogenic variants. This work will conduct to a MD thesis of a clinical resident geneticist in France. Physician that will participate will fill an Excel sheet regarding the clinical and neuropsychological assessment. The investigators will be also happy to have either CD-ROM or a link to have access to the brain MRI data as well as a DNA sample with a minimum 0.5ug of peripheral blood genomic DNA. The investigators will gather the DNA in Montpellier genetic lab (Dr Mouna BARAT) and send the batch to the Dr Sadikovic' lab. Between 2019 and 2020, The investigators have already recruited data from individuals with CDK13 pathogenic variants from France and several European genetic centres.

NCT ID: NCT04337697 Active, not recruiting - Stroke Clinical Trials

Neonatal Seizure Registry - Developmental Functional EValuation

NSR-DEV
Start date: March 15, 2020
Phase:
Study type: Observational [Patient Registry]

The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.

NCT ID: NCT04308954 Terminated - Clinical trials for Fragile X Syndrome (FXS)

Neuroimaging GABA Physiology in Fragile X Syndrome

Start date: November 1, 2016
Phase: Phase 1
Study type: Interventional

The investigators wish to compare the brain distribution of GABA(A) receptors and GABA levels in young adult males with Fragile X Syndrome compared to idiopathic intellectual developmental disorder. The radiopharmaceutical [18F]flumazenil has been used to study GABA(A) receptor distribution in other genetic syndromes with autistic features; however, despite overwhelming evidence supporting the importance of the GABAergic system in FXS, no clinical investigation of this system in human FXS has been reported in the literature. Therefore, this study will provide the first in vivo comprehensive examination of the GABAergic system in FXS using hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI).

NCT ID: NCT04297891 Recruiting - Spastic Ataxia Clinical Trials

Phenotypes, Biomarkers and Pathophysiology in Spastic Ataxias

SPAX-PBP
Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to determine the clinical spectrum and natural progression of Spastic Ataxias (SPAX) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

NCT ID: NCT04294082 Withdrawn - Clinical trials for Intellectual Disability

Study of Mindfulness Course for Parents of Adults With Intellectual Disabilities

Start date: April 1, 2020
Phase:
Study type: Observational

Being a parent to an adult person with learning disabilities can be very stressful, and can lead to experiencing mental health problems. Not much is known about what sort of support services should be offering to these parents; and not many options are available as a result. This study will try to find out if a short intervention, known as a mindfulness-based intervention (MBI), can be of help to these families. A mindfulness-based intervention is one that aims to increase someone's mindfulness, which is the ability to be aware of the present, in a non-judgemental fashion. Simply put, what the investigators would like to find out from this study is: "Can a short course of MBI help improve the well-being of parents of adults with learning disabilities?" To answer this question, the investigators will seek to invite parents to attend a mindfulness course of the duration of 4 sessions. Parents will be invited to participate by NHS staff at their local Community Learning Disabilities Team, who will hand out information sheets and consent forms. Parents will be informed that they may choose to withdraw from the study at any time without this having any negative effect. The investigators will also ask parents to provide feedback on their experience of the course using online questionnaires. Parents will be asked to complete the questionnaires at 6 points: 1 month before the start of the course, at the start of the course, at the end of the course, and at 3, 6 and 12 months after the course has ended. This way, the investigators will be able to track any changes in how parents rate their well-being; and if these changes persist in the long-term. At the end of the study, participants will be offered information on the results.

NCT ID: NCT04277130 Completed - Clinical trials for Intellectual Disability

Effectiveness of Active Video Games in Children With Intellectual Disabilities

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Background: Children with intellectual disabilities (ID) are more vulnerable to obesity when compared to the normal children (Getchell et al., 2012; Maiano, 2011). Active video games (AVGs) on physical activity (PA) behavior have attracted academic interest and exploration since 2000. It has been demonstrated that an intervention with AVGs is compatible with the school setting and behavioral change in health and PA (Lau, et al., 2015). However, special populations such as ID children and their needs have been neglected in this area (Martins, Carvalho & Soares, 2011). ID children's PA behavior, motor ability and physical fitness is still an under-explored area. Aims: To determine the effect of a prescribed AVG intervention on ID children's PA levels (sedentary, light, moderate, and vigorous), motor ability, and physical fitness. The intervention effects in children with mild intellectual disability will be explored. Design: A standard two-arm parallel, single-blinded, randomized control cluster trial. Schools: Participants will be recruited from six special schools in Hong Kong. Schools with same intellectual disability categories will be randomly assigned into intervention group and control group. Participants: 200 Children aged 8~18 years old with intellectual disabilities will be recruited. Intervention: ID children randomized to the intervention group will participate in an AVG intervention 60 minutes per week for 12 weeks in their PE class, in addition to their usual activity levels. The research team will prescribe updated AVG consistent with moderate-vigorous intensity. Control: The control group will continue with usual PA alone and will not receive the AVG intervention. Analysis: Repeated measures mixed model (2 groups X 2 time points (12-week post- test and 8-week follow up test)) by SPSS 23.0 will be used to investigate the intervention effect on primary and secondary outcomes, adjusting for baseline characteristics and correlation between repeated observations. Significance: This will be the pioneering study to provide definitive evidence for the impact of a prescribed AVG intervention on ID children's PA level, motor ability and physical fitness. If effective, this research will provide significant evidence from the innovative method to inform health professionals and PE teachers how to incorporate AVG to enhance physical active behaviors, motor ability and physical fitness in ID children. Finally they may be able to enjoy a better quality of life.

NCT ID: NCT04254666 Completed - Clinical trials for Intellectual Disability

New Skills - No Scores Research Study

Start date: January 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of a physical literacy and food literacy intervention for children with Intellectual Disabilities ages 12-16 years. The Investigators plan to assess preliminary efficacy of the intervention for increasing 1) physical literacy including movement skills, physical self-concept, and desire to participate in physical activity and 2) food literacy including knowledge around making healthy food choices, basic food preparation skills, and engaging in healthy eating behavior.

NCT ID: NCT04250701 Completed - Clinical trials for Intellectual Disability

Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia

Start date: February 15, 2017
Phase:
Study type: Observational

This study investigates physical changes in children with Dyslexia and Intellectual Disability. Participants divided into three groups and Body Posture, Postural Control and Hand Grip Strengths was evaluated.