View clinical trials related to Disease.
Filter by:Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent mental disorders in children and is associated with important negative functional outcomes throughout development. The first signs and symptoms become apparent in preschool age. Therefore, early interventions in this population have the potential of limiting the disorder's negative impact and preventing future impairments in affected individuals. The first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy and safety in preschool children. However, non-evidence based worries and pressure from the media placed parent training as the first-line treatment for ADHD in clinical guidelines. Parent training is a behavioral intervention implemented with the parents, with weekly sessions for 8 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors. However, the level of evidence for this intervention is reduced. Furthermore, the need of trained therapists in the public health system, added to the difficulties on adherence and comprehension from parents, limit its generalization and raise questions regarding its indications. Until now, no study has compared pharmacological treatment with methylphenidate to parent training in preschool children with ADHD regarding their clinical efficacy and cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for determining their impact on neurodevelopment. Objectives: This is a double-blind randomized clinical trial that aims to evaluate the efficacy, tolerability, and acceptability of treatment with methylphenidate compared to parental training and placebo in preschool children with ADHD. Methods: This study will be a randomized, double-blind, parallel-group, evaluating two active interventions and placebo control group. One hundred and fifty children aged 3 years and 11 months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive treatment with methylphenidate and information (50 children), parental training and treatment with placebo medication (50 children) or belong to active control group with educational information for parents and placebo treatment with no treatment (active control, 50 children). The treatment will last eight weeks, the neurobiological outcomes will be assessed before and after treatment and clinical outcomes will be assessed at weeks 0, 5 and 9. After the end of treatment, all participants will be invited to participate in a 3 years' annual follow-up. 50 children with typical development will also be evaluated in relation to neurobiological measures. Implications: This study proposes an innovative and relevant analysis, which will enable the field to advance the knowledge of biological mechanisms related to ADHD and to treatment response. Also, the study will expand the evidence to guide early prevention strategies and early intervention.
The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.
Worry postponement is a commonly recommended treatment component in cognitive behavioral therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally occurring instances of worry to a designated 30 minute "worry period" later in the day. Despite being commonly recommended, there is little known about the efficacy and mechanisms of worry postponement. The purpose of this study is to determine the efficacy and mechanisms of change of a two-week worry postponement intervention in people with Generalized Anxiety Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only control condition. Changes in worry or associated features will be examined at post intervention and at a 2-week follow up.
This study aims to identify signs of depression and bipolar disorder by measuring changes of certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use these biomarkers to develop a diagnostic test to enable early treatment, which can lead to better patient outcomes.
This pilot project is a cooperative effort between the Leisure in Fun Environments (LIFE) Program and the Specialized Communication Resources for Children (SCRC) Program at the Rehabilitation Centre for Children (RCC). The investigators will blend and enhance two pre-existing programs in order to provide a new, specialized program for parents of children with ASD or developmental delay. The two programs that will be blended together are "Promoting Flexible Thinking and Interaction with Your Child at Home" and "Saturday Cooking Club." This new program will be a series of ten workshops that alternates between "parents only" learning sessions and practical "cooking club" sessions that allow parents to focus on practicing what they are learning with their child. These programs are based on the principles of Relationship Development Intervention (RDI®), which focuses on providing opportunities to establish a guided participation relationship, which will lead to development of dynamic intelligence and important social thinking abilities. The program is individualized to each child and builds on the principles of typical development to assist the child in achieving social competence. Using this program, children are expected to develop sociability in a naturally progressing order of complexity.
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and benefit of Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR) in the treatment of individuals with Cannabis Use Disorder (CUD) and Attention-deficit/Hyperactivity Disorder (ADHD). The investigators plan to enroll 50 and randomize 40 of these patients in the trial. The primary objective of the study is to determine the efficacy of MAS-XR in promoting cannabis abstinence among individuals with CUD and in promoting a decrease of ADHD symptoms.
The purpose of this study is to identify psychopathology (psychiatric symptoms) that can differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no language impairment Autism Spectrum Disorder) (AS) in young adults. With our present knowledge, the differentiation between AS and SD can be difficult, as they both present with social difficulties, odd (but not psychotic) behaviour, and a 'feeling of not being as everyone else'. Studies suggest that adults with AS symptoms are either overlooked, or diagnosed within the schizophrenia spectrum in Adult Psychiatry. A 'correct' diagnosis is important, as it is the first step towards the most optimal plan, treatment and rehabilitation for the patient. The only way to diagnose psychiatric illness is the description of present psychopathology. To identify symptoms that can differentiate between the two disorders, we will use semi-structured interviews to explore present psychopathology in young adults with typical symptoms of SD and AS respectively, with special focus on presence of alterations in self-experience. Alterations in self-experience are typical for the schizophrenia spectrum, and are therefore not thought to be equally present in AS and SD. The hypotheses are that the total level of altered experiences is higher in SD, than in AS, and with a different pattern of altered experiences in SD than in AS. If the hypotheses are true, an examination of altered self-experience will be valuable to aid clinical differentiation between the two disorders.
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ). The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information. It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .
Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.
The purpose of this pilot intervention trial is to assess the efficacy of newly developed psychoeducation guides designed to manage anxiety in Autism Spectrum Disorder (ASD) by recruiting 30 participants with ASD and high levels of anxiety along with their parent/caregivers who both receive a version of the psychoeducation guide.