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NCT ID: NCT06129396 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

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

The goal of this clinical trial is to investigate the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensity in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes in respect to executive functions. The main questions it aims to answer are: - To find out the effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD - To examine the relationship between neurophysiology and executive functions following a single bout of aerobic exercise intervention Participants will be asked to do three different executive function tasks regarding inhibitory control, working memory and cognitive planning and receive the evaluation of motor cortex excitability via transcranial magnetic stimulation (TMS) before and after a single bout of 30-min aerobic cycling exercise of moderate intensity. Researchers will compare the control group with 30-min video-watching to see if effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD.

NCT ID: NCT06123741 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

VREALFUN-ADHD
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations. The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress. Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.

NCT ID: NCT06019429 Recruiting - Healthy Clinical Trials

Promoting Social-emotional Development and Self-esteem in Primary School Students

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

This is an effectiveness study into a program ("HiRO") for improving social-emotional development, self esteem and the perceived classroom peer context in primary school students (aged 4-13 years). To this end, schools are divided into three conditions based on the choice of the schools (non-randomized): 1) School As Usual, 2) HiRo without judo classes, and 3) HiRO with judo classes. In all participating schools, social-emotional skills, self-image, emotional problems, and classroom peer context are measured three times by means of questionnaires (both self-report and parent-report). In The Netherlands primary schools are obliged to offer students training in social-emotional development. Schools can decide to develop their own program or make use of existing programs delivered by third parties, such as HiRO. In this study HiRO is compared to school as usual, that is, any other program offered to promote social -emotional development than HiRO. The main questions to answer are: - What is the effect of HiRO on the development of prosocial behavior? - What is the effect of HiRO on the development of emotional problems (depression, anxiety)? - What is the effect of HiRO on self-esteem? - What is the effect of HiRO on perceived peer context? Researchers will compare HiRO with and without judo to "school as usual" testing the following hypotheses: HiRO will result in increased prosocial skills as compared to school as usual. HiRO will result in decreased emotional problems as compared to school as usual. HiRO will result in increased self-esteem as compared to school as usual. HiRO will result in improved perceived peer context as compared to school as usual.

NCT ID: NCT06012851 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. The current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones. The main questions to answer are: Is parenting feedback provided by a smartphone application acceptable to caregivers? When parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?

NCT ID: NCT05924594 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301

Start date: July 31, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting.

NCT ID: NCT05869253 Recruiting - Clinical trials for Attention-deficit Hyperactivity Disorder

The Efficacy of Equine Assisted Occupational Therapy, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation

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

The goal of this clinical trial is to develop and validate an Equine Assisted Occupational Therapy Intervention for children aged 6-12 with Attention Deficit Hyperactivity Disorder. The research aims to study the effect of an EAOT intervention on cognitive-emotional aspects, daily function and participation among these children using various measurements including physiological measures (EEG, heart rate for rider and horse), questionnaires and different tasks. It aims to enable the creation of an evidence based protocol for professionals in order to provide a better suited therapy for children with ADHD and enable them to live a full life. Participants will enroll in a 12 week EAOT intervention including one session per week of 45 minutes with a waiting period prior the intervention. Participants will go through assessments prior waiting time, prior the intervention and post intervention.

NCT ID: NCT05778526 Recruiting - Virtual Reality Clinical Trials

Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder

Start date: February 18, 2023
Phase: N/A
Study type: Interventional

The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality-based intervention, (2) investigate its effects on improving the social skills and executive functioning of inhibitions, emotional control and attention of the children compared to traditional social skills training and (3) evaluate the subjects acceptability and compliance with social VR training for enhancing social interaction skills. It is hypothesised that the social interaction skills of the participants in the social VR training group are likely to perform better than those in the traditional social skills training group. Participants in the waitlist control group will receive no change in social interaction skills compared with the two intervention groups.

NCT ID: NCT05741307 Recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder

HYPNAAX
Start date: September 4, 2023
Phase: N/A
Study type: Interventional

The prevalence of Attention Deficit/ Hyperactivity (ADHD) varies between 3 and 10% depending on the studies. Comorbidities are frequently associated, in particular anxiety disorders. School, social and family consequences of ADHD can be major, especially in the presence of a comorbidity. The study goal is to evaluate, through questionnaires, the effect of self-hypnosis via a smartphone application, on the symptoms of inattention and anxiety in children with ADHD in addition to their treatment by methylphenidate. Parents and children complete the study questionnaires four times. - T0: at inclusion - T1 (T0+6 weeks): after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment / after 6 weeks of usual treatment for the group 2 - T2 (T0+8 weeks): after a wash-out period of 2 weeks (usual treatment only) for both groups - T3 (T0+14 weeks): after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment / after 8 weeks of usual treatment for the group 1, following the 6 weeks of use of the application.

NCT ID: NCT05721235 Recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

KP415P02
Start date: May 24, 2023
Phase: Phase 4
Study type: Interventional

The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.

NCT ID: NCT05718427 Recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD

ASI-ADHD
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

Attention Deficit Hyperactivity Disorder (ADHD) is a very common neurodevelopmental disorder in childhood characterized by short attention span, impulsivity and hyperactivity. It is also known that sensory integration problems are seen together with the basic symptoms of ADHD. Studies indicate that children with ADHD have difficulties in perceiving and processing sensory stimuli, and in relation to this, they have difficulty in producing appropriate sensory responses at school, at home and in social environments. However, it was observed that the interventions related to ADHD did not focus on the sensory-motor dimension enough, and focused more on cognitive or social skills. Although current research indicates the presence of sensory integration disorder in children with ADHD, there are no studies showing the effectiveness of sensory integration intervention. Our study was planned to examine the effect of Ayres Sensory Integration intervention on sensory-motor, cognitive, behavioral skills and social participation in children with ADHD. Materials and Methods: After the evaluation, 90 children with ADHD will be included in the study by dividing them into intervention (n=45) and control (n=45) groups by simple randomization method. Ayres Sensory Integration Therapy intervention will be applied to the intervention group for 10 weeks, 3 times a week, with a session duration of 1 hour, while the control group will continue the drug treatment and after a waiting period of 10 weeks, Ayres Sensory Integration Therapy will be applied after the second evaluation. Participants, Sensory Profile (SP), Sensory Integration and Praxis Test (SIPT), Emotion Regulation Checklist (ERC), Stroop Test TBAG Form (Stroop TBAG), Childhood Executive Functions Inventory (CHEXI), Participation and Environment Scale for Children and Adolescents (PEM-CY), Conners Teacher Rating Scale (CTRS), Conners Parent Rating Scale (CPRS), Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) and Goal Achievement Scale (GAS) both before and before intervention. and post-group change as well as between-group differences will be evaluated.