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ADHD clinical trials

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NCT ID: NCT06081348 Not yet recruiting - Anxiety Clinical Trials

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

CALM
Start date: October 2023
Phase: Phase 2
Study type: Interventional

There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.

NCT ID: NCT05841212 Not yet recruiting - ADHD Clinical Trials

DBT Skills Group for Adolescents With ADHD

Start date: December 2023
Phase: N/A
Study type: Interventional

Attention Deficit Hyperactive Disorder (ADHD) is linked to three main symptoms: hyperactivity, inattention and impulsivity. It is increasingly being acknowledged that these symptoms have a wide-reaching impact on a person's life. Adolescents with ADHD are six times more likely to be excluded from school, have difficulties turn taking, express anger more often, have poorer emotion regulation and self-report a lower quality of life. In adulthood, people with ADHD are more likely to develop mental health difficulties, and to experience unemployment, divorce and be imprisoned. It is thought that emotion regulation and poor social skills are key factors leading to increases in mental health difficulties and poorer long term social outcomes. This pilot trial will look at whether an intervention which aims to increase emotion regulation and social functioning is acceptable and feasible. The intervention will be an adapted Dialectical Behaviour Therapy (DBT) skills group with an ADHD focus. DBT is an approach that aims to provide skills to assist an individual identify what they are feeling and change what they do in response to that feeling. For example, if an individual feels anger and the urge to be aggressive, DBT helps them to problem solve and find a more effective way of responding to their anger. Also, if an individual wants to communicate a relational need to others DBT helps them think about the most effective actions they can take to achieve this outcome. The intervention will be developed in collaboration with adolescents with ADHD. The intervention will then be delivered at the child and adolescent outpatient clinic site they received their diagnosis from. All participants will have a confirmed diagnosis of ADHD. Pre and post measures will be collected and reported on. The research team hope to commence recruitment in July 2023 and finish all data collection by 31st March 2024.

NCT ID: NCT05752422 Not yet recruiting - ADHD Clinical Trials

Transcranial Photobiomodulation for Adult ADHD

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

This study aims to assess the behavioral as well cognitive changes in ADHD symptoms in terms of improvement of inhibitory control and attention in adults with ADHD

NCT ID: NCT05635318 Not yet recruiting - ADHD Clinical Trials

Quantitative EEG Neurofeedback as an Add-on Therapy For Attention-deficit Hyperactivity Disorder (ADHD)

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

Attention deficit/hyperactivity disorder (ADHD) is a common neurological disorder in children, mainly manifesting as attention deficit, excessive hyperactivity, and impulsivity. It is a chronic condition that affects millions of children and often continues into adulthood. The prevalence of ADHD in the worldwide is approximately 5%, predominantly occurring in boys, and more than half of patients continue to experience symptoms into adulthood. Children with ADHD have moral disorders and learning difficulties, and these factors will seriously affect their academic achievements and familial and social relationships; thus, treatment is necessary. Currently, the treatment for ADHD is usually pharmacological intervention, such as methylphenidate, Atomoxetine…. etc. However, research has suggested that pharmacological intervention has side effects on nervous system development in children, and the long-term efficacy is uncertain. In recent years, the efficacy of neurofeedback (NF) therapy, as a type of biofeedback method, has been proven in many diseases, such as mild cognitive impairment, epilepsy, and autism, depression, and anxiety. NF converts signals such as EEG into visual or auditory information, and then subjects selectively enhance or inhibit certain components through training. There are three common NF protocols for ADHD: theta/beta training, sensorimotor rhythm (SMR) training, and slow cortical potentials (SCP) training. This study adopts the theta/beta NF protocol. As a promising nonpharmacological alternative treatment for ADHD, the efficacy of NF has been proven in many studies. The use of quantitative EEG neurofeedback as an add-on therapy can be markedly beneficial to shorten the period of pharmacological treatment and with minimal side effects.

NCT ID: NCT05410626 Not yet recruiting - Adhd Clinical Trials

The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original

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

This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment

NCT ID: NCT05386251 Not yet recruiting - ADHD Clinical Trials

Effectiveness of a Digital Strategy-based Educational Skills Group for Secondary Students With Organization and Academic Motivation Challenges

STAND-G
Start date: May 18, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to test the effectiveness of a telehealth-delivered skills training versus active control group for middle and high school students with ADHD symptoms. Both programs will be delivered digitally (via Zoom). Investigators will measure student functioning at baseline, post-group, and three-month follow-up. The primary outcomes are ADHD symptoms, student grade point average, and attendance as reported in the gradebook. Secondary outcomes include parent academic support, autonomy, academic motivation, and organization skills. Participant satisfaction with the group will be measured post-group. Group attendance and homework completion will also be measured.

NCT ID: NCT05368324 Not yet recruiting - ADHD Clinical Trials

Improvement of Planning Skills in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV

CogFun-RV
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The main aim is to know the effectiveness of a program, CogFun-VR, through the use of immersive virtual reality, to improve executive skills, such as self-regulation, organization, planning and time management in life. of children and adolescents with ADHD, between 9 and 16 years old. The study design is a randomized clinical trial, with a control group on a waiting list. The estimated sample size is 82 participants: 41 in the experimental group and 41 in the control group. Participants will be randomly assigned to one of the two groups. Four measurements of the variables of interest will be conducted, in the beginning, after the 12-week duration of the intervention, at 3 months and 6 months as a follow-up. The BRIEF, SNAP-IV, SDQ, EQi: YV and several subtests of the WISC-%, BADS and NEPSY-II will be used. All participants will be assessed by an independent evaluator who will be blinded. The intervention program is manualized to assess its integrity and reliability.

NCT ID: NCT05208255 Not yet recruiting - Adhd Clinical Trials

Effect of Telerehabilitation-Based Exercise and Motor Imagery Training in Children With ADHD

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders with heterogeneous clinical features such as inattention, hyperactivity, and impulsivity. It has been shown that one-third of children with ADHD have problems with tasks that require fine and gross motor skills. In addition, it was stated that the motor skill problems experienced during dynamic balance tasks were more pronounced than typically developing children. The motor problems seen in children with ADHD may be caused by dysfunction in some related brain regions that delayed or impaired cerebellar development may contribute to the pathophysiology of ADHD. Motor imagery skills have been investigated as the underlying cause of motor impairment in children with ADHD and Developmental Coordination Disorder (DCD). Although it has shown that motor imagery is markedly impaired in children with DID; It has been stated that this situation is not clear in children with ADHD. Motor imagery is the mental thinking of a movement without actual movement being revealed. It has been reported that combined physical and mental programs applied at different rates, as well as motor imagery training without physical exercise, are effective in improving postural control. In a study conducted with children with DCD, it was shown that motor imagery training improves children's movement skills. In the treatment of ADHD, there are multidimensional treatment approaches that include medical and psychosocial interventions. Pharmacological treatments, including stimulant and non-stimulant drugs, are highly effective in reducing ADHD symptoms and the disruptive behaviours associated with them. Also, physical exercises are known to reduce ADHD symptoms. Exercise methods enable patients receiving drug therapy to respond better to drugs, it has been shown to improve cognitive functions in ADHD cases. In conclusion, the underlying aetiology of motor imagery skills and motor coordination and balance problems in ADHD is not clear. The use of telerehabilitation methods has become widespread due to the difficulties in conducting face-to-face treatment and follow-up processes during the pandemic process. In addition, there is no exercise program based on telerehabilitation and motor imagery in children with ADHD. This study aims to examine the effects of telerehabilitation-based exercise and motor imagery practices on ADHD symptoms and balance skills in children with ADHD.

NCT ID: NCT05182424 Not yet recruiting - ADHD Clinical Trials

Randomized Controlled Trial of the Myndlift BPT App

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

We propose addressing these aims by conducting a randomized controlled trial (RCT) that will evaluate the hybrid BPT (Myndlift BPT) compared to a wait-list control group. All participants will receive the Myndlift BPT at either the initial point of randomization or following the wait-list time period. The Myndlift BPT consists of 10, self-directed app-based BPT modules accessible through an online mobile application with each module requiring up to 30 minutes of parent's time. Therapist contact ("parent-therapist consults") will be based on parent need. We anticipate approximately six standard 20-minute therapist contacts during the Myndlift BPT (one prior to the start of the app-based BPT modules, four parent-therapist consults during the app-based BPT modules, and one final parent-therapist consult at the end of app-based BPT modules). Additional parent-therapist consults will be based on parents' needs. In addition, therapists will monitor parent progress and challenges with the app-based BPT modules using a web-based therapist portal. The therapist may initiate additional parent-therapist consults if s/he deems it necessary based on client progress, and contacts can be longer than 20 minutes if needed. All consults are completed through Zoom telehealth platform. Given the self-directed nature of the Myndlift BPT (parents decide how frequently they access the app-based modules of BPT and practice the skills), parent involvement in the intervention will vary slightly in duration. However, based on the literature and routine practice, we anticipate parents completing one module/week in the app-based parent feature for a total of 10 weeks with an additional therapist supported session at the start of the intervention and one at the end of the intervention for a total of 12 weeks of involvement in the Myndlift BPT. The research assessment (see details below) will occur at baseline and at the end of Myndlift BPT. Given that the assessments are linked to participant progress in the Myndlift BPT, participant involvement in the study will also slightly vary, but we anticipate that most parents will complete the assessment during a standard 12-week Myndlift BPT schedule.

NCT ID: NCT04418921 Not yet recruiting - ADHD Clinical Trials

Improving Self-regulation in Children With Neurodevelopmental Disorders:

Start date: October 2022
Phase: N/A
Study type: Interventional

Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years old with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of "SF-MRehab: Un colegio emocionante", a non-inmersive virtual reality system where virtual objects can be managed by children in a natural way by using their hands. Children will be recruited from several schools from Granada (Spain) and they will be randomly allocated to two groups. Assessment will be conducted before and after the intervention as well as 24 weeks after the end of the intervention process. Experimental group will receive the intervention using virtual reality. Control group will receive the intervention through a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as acceptability of technology with the use of SR-MRehab will be evaluated. The results will be published and will contribute with evidence regarding the use of this type of intervention on children with neurodevelopmental disorders