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Intellectual Disability clinical trials

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NCT ID: NCT05295277 Recruiting - Clinical trials for Autism Spectrum Disorder

Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort

Start date: November 30, 2020
Phase:
Study type: Observational

The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system. SVs are a type of genetic alternation that includes deletions, duplications, and both balanced and unbalanced rearrangements (ex: inversions or translocations), as well as specific repeat expansions and contractions. The results of OGM analysis will be compared to prior clinical genetic test results to determine how OGM compares to current standard of care (SOC) clinical test methods such as chromosomal microarray analysis (CMA), karyotyping, Southern blot analysis, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), and/or next generation sequencing (NGS), etc.

NCT ID: NCT05273320 Recruiting - Clinical trials for Intellectual Disability

Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities

N-AND
Start date: March 17, 2022
Phase: Phase 1
Study type: Interventional

Innovative treatments are urgently needed for severe behavioural problems (SBPs) in adults with intellectual and developmental disabilities (IDD). Although a synthetic cannabinoid, nabilone may be a plausible and safe alternative to treat SBP, safety and efficacy of nabilone in people with IDD has never been evaluated. The investigators propose to conduct this first-ever Phase I pre-pilot open-label clinical trial to collect data on the tolerability and safety profile of nabilone in adults with IDD, and explore changes in SBP pre- and post-treatment. The results will inform a next-stage pilot randomized controlled trial, followed by a fully powered trial eventually.

NCT ID: NCT05273021 Recruiting - Substance Use Clinical Trials

Validation of the Dutch Translation of the Tobacco, Alcohol, Prescription Medication and Other Substances (TAPS)-Tool

Start date: July 1, 2021
Phase:
Study type: Observational

The aim of the study is to investigate the reliability and validity of the Dutch version of the TAPS-tool. This will be investigated in 2 groups: patients without intellectual disabilities treated in Flexible Assertive Community Treatment (FACT) teams and patients with intellectual disabilities. For the later group, an adjusted version of the TAPS-tool will be developed. For both groups the TAPS outcome will be compared to a golden standard.

NCT ID: NCT05214859 Recruiting - Clinical trials for Intellectual Disability

Enhancing Mother-Child Ties and Psychosocial Wellness Through Arts Among Children With Intellectual Disability and Their Mothers

Start date: July 9, 2022
Phase: N/A
Study type: Interventional

The caregiving of children with intellectual disability (ID) is intensive and challenging. Caregivers, particularly mothers, are left in a vulnerable and stressful condition. Children with ID may experience difficulties in expressing emotions and may have behavioral or emotional problems. These difficulties impose extra challenges for the parents to understand and interact with their children with ID. Existing intervention programs for families having children with ID primarily focus on problem-and-emotion-focused measures. While strategies focusing on improving parent-child relationships, mother-child communication, and wellness of the dyads are limited. Expressive arts-based intervention (EXAT) adopts multiple art modalities for achieving therapeutic goals. It can bypass verbal expression and complicated cognitive processing during interactions, and it is also safe, engaging, enjoyable, and empowering. While existing evidence supports the use of arts-based intervention on children and their parents, there is a limited understanding of the application of dyadic EXAT on the mother-child relationship and their wellness. The main objective of this study is to evaluate the effectiveness of the dyadic Expressive Arts-based Intervention (EXAT) on the psychosocial well-being of mother-child dyads. Primary outcomes include parent-child relationship, parenting stress, and caregiver burnout; secondary outcomes include mother's affect and quality of life; child's mood, emotional expression, behavioral and emotional problems. This study adopts a mixed-methods design with quantitative, qualitative, and art-based assessment methods. This study is a randomized controlled trial, running for 3 years for evaluating the effectiveness of the dyadic Expressive Arts-based Intervention (EXAT). 154 Chinese mother-child dyads will be randomized into (i) a dyadic EXAT group or (ii) a treatment-as-usual waitlist control group. Quantitative analysis will be adopted to investigate the effectiveness of the dyadic intervention on the psychosocial outcomes of children with ID and their caregiving mothers. The qualitative component will consist of longitudinal in-depth interviews with mothers to understand the experiences, perceived changes, and factors that facilitate the process. Art-based assessment will also be used to understand the changes in the emotional expression of children with ID. Data collected will be triangulated to provide an integrative evaluation of the effectiveness of the intervention.

NCT ID: NCT05131425 Recruiting - Anxiety Clinical Trials

Facing Your Fears: Adolescents With ASD and Intellectual Disability

FYF:ASD/ID
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Adolescents with ASD and intellectual disability (ID) are a complex and underserved population. Approximately 50% of individuals with ASD/ID experience significant anxiety. Yet, there are very limited mental health care interventions available for this population. Addressing anxiety and building coping skills is particularly important during adolescence as coping skills can support a successful transition to adulthood and family functioning during a difficult developmental period. The current investigators adapted a cognitive behavioral treatment (CBT) manualized intervention, Facing Your Fears, for adolescents with ASD/ID (FYF:ASD/ID) and completed a pilot study with 23 teens. Preliminary results indicated significant improvements in anxiety and mood symptoms. The proposed study seeks to test whether FYF:ASD/ID is more effective in reducing anxiety than treatment-as-usual (TAU). The investigators propose a Randomized Control Trial (RCT) with 36 adolescents with ASD/ID (12-18 years) randomized to FYF: ASD/ID and 36 adolescents randomized to TAU for 14 weeks. The 36 teens randomized to TAU will then cross-over and complete FYF:ASD/ID. Evaluations will take place at Baseline, Post-Intervention, and 6-month follow-up. Teens in the TAU will have two baseline assessments prior to crossing over to FYF:ASD/ID; both groups will complete a 6-month follow-up assessment after finishing FYF:ASD/ID. There are three aims for this project: (1) examine the efficacy of FYF: ASD/ID relative to TAU in improving anxiety as measured by parent report and determine if any gains noted in the FYF:ASD/ID are maintained at 6-month follow-up; (2) examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYF:ASD/ID; and (3) examine whether adolescents' independent use of CBT skills (as assessed by goal attainment ratings of prompting level required to use strategies) to manage anxiety are increased following participation in FYF:ASD/ID.

NCT ID: NCT05040542 Recruiting - Brain Development Clinical Trials

The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years

Start date: August 1, 2021
Phase:
Study type: Observational

This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors in it.To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.

NCT ID: NCT05025332 Recruiting - Clinical trials for Pitt Hopkins Syndrome

An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001)

PTHS-001
Start date: October 14, 2022
Phase: Phase 2
Study type: Interventional

A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Pitt Hopkins Syndrome.

NCT ID: NCT04938999 Recruiting - Clinical trials for Intellectual Disability

Music-visual Guided Physical Activity Promotion for Adults With Intellectual Disabilities

Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Objective: Although physical activity (PA) is cardiometabolic and psychologically beneficial to adults with intellectual disability (ID), its initiation and maintenance remain problematic. We examine the effects of a music-visual guided PA (MVgPA) intervention on the PA level, PA self-efficacy and interest as well as functional exercise capacity of adults with ID. Hypothesis: Compared with usual care, MVgPA can significantly increase the participant's PA level and improve their PA self-efficacy and interest, and functional exercise capacity. Design and participants: This cluster-randomized controlled trial will recruit 400 Chinese adults with mild to moderate ID from 20 residential care facilities. Intervention: Based on the information-motivation-strategy model, MVgPA comprises a motivational and strategical preparatory session and ongoing support to residential service providers and a 12-week group-based staff-facilitated MVgPA (two 75-min session/week) for adults with ID. Outcome measurement PA level (primary outcome) will be measured by using an activity tracker. PA self-efficacy and interest will be measured by the Baseline Interview Questionnaire and visual analogue scale respectively. Functional exercise capacity will be measured by six-minute walk test. All outcomes will be measured at baseline, 13 and 25 weeks. Data analysis: Intervention effects will be estimated using three-level mixed effects model. Expected results: MVgPA will effectively enhance the PA levels of adults with ID. After intervention implementation, we expect that at least 50% of the residential care facilities allocated to the intervention group will demonstrate their willingness to continue to implement the MVgPA program (score 4 out of 6, 6 = most willing).

NCT ID: NCT04919213 Recruiting - Clinical trials for Intellectual Disability

Safer Online Lives: Use of the Internet & Social Media by People With Intellectual Disabilities

SOL
Start date: May 20, 2021
Phase:
Study type: Observational

The objective of this study is to explore the benefits of internet use for people with intellectual disabilities (ID), the risks they might come up against while online, the barriers people with ID might come across due to the 'digital divide', and the opportunities offered by being online. The views and experiences of family carers and/or paid carers as well as the views of other safeguarding practitioners will also be investigated.

NCT ID: NCT04821856 Recruiting - Clinical trials for Intellectual Disability

Evaluation of the Effectiveness of Cannabidiol in Treating Severe Behavioural Problems in Children and Adolescents With Intellectual Disability

Start date: May 11, 2021
Phase: Phase 2
Study type: Interventional

This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 weeks in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.