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Intellectual Disability clinical trials

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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.

NCT ID: NCT06019182 Recruiting - Obesity Clinical Trials

MEHMO Natural History and Biomarkers

Start date: May 19, 2024
Phase:
Study type: Observational

This observational natural history study will follow individuals with MEHMO (Mental disability, Epileptic seizure, Hypopituitarism/Hypogenitalism, Microcephaly, Obesity) syndrome or an eIF2-pathway related disorder, who have symptoms such as intellectual delay, seizures, abnormal hormone and blood sugar levels, and decreased motor skills. No current treatment for these conditions is available. A major impediment to the testing of potential therapeutic interventions is the lack of well-defined outcome measures. This protocol seeks to identify biochemical and clinical markers to monitor disease progression, and better understand the natural history of these conditions. Any person diagnosed with MEHMO syndrome or related conditions, who can travel to the NIH Clinical Center can participate in this study. The study involves: - General health assessment and evaluation - Imaging studies - Laboratory tests - Collection of blood, urine, spinal fluid, skin biopsy.

NCT ID: NCT06018298 Completed - Mental Disorder Clinical Trials

Evaluation of Excellence in Italy's Residence for Execution of Security Measure

ITAL-EE-REMS
Start date: July 1, 2018
Phase:
Study type: Observational

The model of care for forensic psychiatry in Italy was changed by law (Law 81/2014) so that the six legacy secure forensic hospitals (Judicial Psychiatric Hospitals, OPG) were closed and new secure community residences for the execution of security measures (REMS) were opened in each of the 20 regions of Italy. This transition was in place by 2015. This observational study evaluates the health gains for patients both previously in OPGs and those admitted first to REMS. Health gains assessed include recovery measured by symptoms, function, need for therapeutic security and recovery of legal autonomy.

NCT ID: NCT05940168 Active, not recruiting - Depression Clinical Trials

Internet-delivered ACT (I-Navigator ACT) for Parents of Children With Disabilities

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies: Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment. Study 2: A randomized controlled trial in which participants are randomly assigned either: 1. Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or 2. I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function. Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT. All three studies are conducted in a clinical health care context.

NCT ID: NCT05935722 Recruiting - Clinical trials for Autism Spectrum Disorder

Evaluation of a Home-based Parenting Support Program: Parenting Young Children

PYC
Start date: September 8, 2022
Phase: N/A
Study type: Interventional

Background: Parents with intellectual and developmental disabilities (IDDs) have a tendency to provide insufficient caregiving and often need parenting support to prevent neglect and child removal. However, parents with IDDs are not provided with appropriate support, and there is a lack of evidence-based programmes tailored to these parents' needs. Parenting Young Children (PYC) is a home-based parenting programme developed for parents with IDDs. PYC has shown promising clinical results in interview-based studies, but there is no evidence of its effectiveness. The purpose of the proposed study is to evaluate the PYC programme for improving parenting in parents with IDDs where there is risk of child neglect. The study will include a quantitative evaluation, a process evaluation, and a qualitative evaluation of the children's and parents' perspectives on participating in PYC. Methods: The quantitative evaluation will have a multi-centre, non-randomised, comparative study design. Eligible for participation are parents with IDDs who have children aged 0-9 years living at home and who are assessed as needing tailored parenting support. Thirty parents receiving PYC and thirty parents receiving treatment as usual (TAU) will be recruited from Swedish municipal social services. Outcome variables will be examined before and after the intervention, with a follow-up 6 months after completing the intervention. The primary outcome will be goal-attainment in parenting skills, and secondary outcomes will be parental self-efficacy and children's wellbeing. Interview methods will be used to explore the perspectives of parents and children in the PYC group. Discussion: This study is motivated by the need for evidence-based support for parents with IDDs, and it focuses on upholding the centrality of child-caregiver relationships and family preservation, as well as children's rights and the rights of people with disabilities. Social services have expressed ethical concerns with employing a randomized design for this vulnerable group, and this study will therefore evaluate PYC in a non-randomized comparative study.

NCT ID: NCT05933005 Recruiting - Clinical trials for Mild Intellectual Disability

Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)

Start date: August 9, 2023
Phase: N/A
Study type: Interventional

The goal of this exploratory clinical trial is to test the effects of the computerized cognitive rehabilitation program (D-kit/EF1) for children with borderline intellectual functioning or mild intellectual disability after its use. Participants will use the D-kit/EF1 program on an iOS device 5 times a week for 30 minutes each session, for a duration of 12 weeks. Researchers will compare treatment group that uses D-kit/EF1 with sham group that watches educational videos on the same iOS device.

NCT ID: NCT05922215 Completed - Clinical trials for Intellectual Impairment

Effects of Balance Training on Gait and Functional Strength in Children With Intellectual Disabilities

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

Intellectual impairment is a developmental condition that first appears in childhood and causes substantial intellectual or cognitive limitations as well as inadequate adaptation to the demands of daily life. It may be viewed as a syndrome grouping (meta-syndrome), rather than as an illness or a disability; encompassing a wide range of clinical problems, including hereditary, viral, metabolic, and neurological issues. Prior to learning new abilities, there is a loss in cognitive functioning that is indicative of ID. Falling is a severe issue that affects people with intellectual disabilities frequently. Although studies based on retrospective data collected over time have not determined the exact prevalence of falling in the ID community, they have estimated that 30-60% of people fall within a 12-month period. Similar fall risk factors exist in the general population and in people with ID, such as advancing age, vision problems, and mobility issues. However, some characteristics, such as having frequent seizures and a high level of ambulation, seem more distinctive to ID. The purpose of this study is to analyze the effects of balance training on gait and functional strength in children with mild intellectual disabilities. This will be a Randomized Controlled Trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 intellectually disabled children between the ages of 7 and 14 will be randomly allocated to the Experimental group (n=10) or a Control group (n=10). The Experimental group will be given the Baseline treatment comprising of Static balance training (i.e. heel and toe raises, alternate rising of the left and right foot above the floor and tandem standing.) alongside Dynamic Balance training (weight shifting forward, backward, sideward, and diagonally with eyes opened and eyes closed, walking toe-to-heel barefoot, side walking, reverse walking and one-foot jumps), and Progressive activity training (including stepping over/on obstacles, throwing and catching a ball, and kicking a ball.) for 40 minutes per day, twice each week for 8 weeks. Whereas, the Control group will continue their regular school schedule, which will include participation in physical education activities at the same frequency. Along with that, only Baseline treatment including Static balance training (i.e. alternate rising of the left and right foot above the floor and tandem standing.) will be given at the same intervals and for the same length of time as the intervention group, with the exception of additional Dynamic balance training and progressive activity training. The time up-and-go test, the 10-meter walk test and GMFM-88 were used to evaluate gait, and the Sit-to-stand test and the Stair Climbing test. were used to measure each participant's functional strength. Pre and Post treatment values will be evaluated and the Data will be analyzed using SPSS 22.0.

NCT ID: NCT05902832 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Autism spectrum condition (ASC) is a neurodevelopmental disorder characterized fundamentally by social deficits. Emotional competence - the ability to express, recognize, understand, and regulate emotions - is a key aspect of social communication. Evidence suggests that the developmental trajectories of autistic children differ from that of neuro-typical children regarding their ability to process and recognize emotions from paralinguistic emotional facial, body language, and voice tone cues. They also have difficulty integrating these cues in context and lack in emotional language. Numerous approaches to teaching people with autism how to recognize and understand emotions have been tried, with recent increased interest in computer-based interventions (CBI). However, most of the research focused only on facial expressions, were limited to autistic children with no intellectual disabilities (ID); and showed limited generalization to real social settings. EmotiPlay, a computer-based intervention program, designed to enhance emotion recognition (ER) by addressing multiple modalities of emotional cues (facial expressions, tone of voice, body language), has shown good outcome when used at home by autistic children and no ID . However, the examination of generalization was partial and depended only on parental reports. The present study main goals are to: (1) Examine the adaptation and the integration of EmotiPlay into special education classrooms in regular schools. (2) Assess EmotiPlay's effect on emotional competence among autistic children at different functioning levels.