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NCT ID: NCT06457256 Not yet recruiting - ADHD Clinical Trials

Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico

(CLS-A-FUERTE)
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Neurodevelopmental disorders of Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) are extremely common but underserved with Evidence- Based Treatments (EBT) worldwide. Thus, our team developed, implemented and evaluated a school clinician training and ADHD/ODD intervention (i.e., the Collaborative Life Skills [CLS] program) for Mexico: a setting with high unmet need. We integrated technology into our in-person program (CLS-FUERTE) to create a digitally enhanced version (CLS-R-FUERTE). Given findings demonstrating feasibility, acceptability, and efficacy of both program versions, we propose a Type 2 Hybrid Effectiveness-Implementation Design to evaluate the program effectiveness, mechanisms of intervention change, and maintenance barriers/facilitators in a scaled-up cluster randomized controlled trial across two Mexican states -while simultaneously exploring an implementation strategy in which we adapt the program to enhance maintenance given each school's needs/resources (i.e., CLS-A-FUERTE). Our implementation process is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model with evaluation following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. Aim 1) Test the effectiveness and implementation of the CLS-A-FUERTE school clinician training and ADHD/ODD intervention program adapted for schools across Mexico. We expect: H1) School clinicians will engage in training and implement chosen intervention components with fidelity H2) Teachers and/or families will engage in chosen intervention components and adhere to the strategies H3) Students receiving the CLS-A-FUERTE intervention will show greater improvements in ADHD/ODD symptoms and associated impairment compared to students receiving school services as usual Aim 2) Evaluate mechanisms of sustained intervention change. We expect: H4) Improvements in parenting behaviors will mediate sustained intervention effects H5) Improvements in teacher and/or school clinician competency will mediate intervention effects Aim 3) Identify CLS-A-FUERTE maintenance barriers and facilitators. We expect across adaptations that sustained intervention effects and continuation of program activities at follow-up will relate to: H6) Program feasibility (i.e., cost estimates) and acceptability (i.e., participant satisfaction) H7) Characteristics of participating schools and school context factors Aim 4) Expand research capacity to a novel university setting. We expect emerging investigators will: H8) Complete clinical research coursework and produce deliverables (i.e., presentations, papers, grants) H9) Show improved EBT skills, research capacity and culture ratings, and competency as program trainers

NCT ID: NCT06456372 Not yet recruiting - ADHD Clinical Trials

Digital Health Intervention for Children With ADHD

Start date: September 30, 2024
Phase: N/A
Study type: Interventional

To conduct an RCT to evaluate the efficacy of the system, we will recruit 60 children (ages 8-12) with ADHD who will be randomized to either immediate (n=30) or delayed (n=30) treatment (i.e., a wait-list control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application) and half will be assigned to an active control treatment as usual (TAU) group who will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, he or she will be assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention and 30 will complete the active control, with half of the total sample also completing a wait-list period.

NCT ID: NCT06389864 Not yet recruiting - ADHD Clinical Trials

rTMS in Children and Adolescents With ADHD:

Start date: June 2024
Phase: N/A
Study type: Interventional

Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively.

NCT ID: NCT06378281 Not yet recruiting - ADHD Clinical Trials

Testing a New Method to Improve Informed Consent in Prison Research

Spark BATIR
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations.

NCT ID: NCT06359899 Not yet recruiting - ADHD Clinical Trials

A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD

Start date: May 2024
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder(ADHD).

NCT ID: NCT06330779 Not yet recruiting - Pain Clinical Trials

Trauma-adapted Yoga in Child & Adolescent Psychiatry.

TAY-CAP
Start date: January 1, 2025
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health & quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences & parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice. Within and between group (yoga group vs waiting list) analyses will be performed.

NCT ID: NCT06305429 Not yet recruiting - ADHD Clinical Trials

Encouraging Positive Parenting Habits

HABITE
Start date: June 2024
Phase: N/A
Study type: Interventional

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study.

NCT ID: NCT06284655 Not yet recruiting - ADHD Clinical Trials

The Effect of a Brief Educational Intervention for Adults With ADHD

Start date: March 2024
Phase: N/A
Study type: Interventional

This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD.

NCT ID: NCT06189703 Not yet recruiting - ADHD Clinical Trials

tRNS Treatment for ADHD Symptoms

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

A randomized, sham-controlled, double-blind clinical trial to examine the safety and effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD. Subjects will undergo either tRNS or sham treatment for 10 days during a two-week period in a home-simulated environment. Each treatment session is 20 minutes, during which their attention will be maintained using a software game.

NCT ID: NCT06146595 Not yet recruiting - ADHD Clinical Trials

Prevalence of Attention Deficit Hyperactivity Disorder and Its Comorbidities

Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

Estimate the prevalence of attention deficit hyperactivity disorder and comorbid psychiatric disorder among primary school students in New Valley governorate.