Executive Function Training for Children and Adolescents

Официальное название

Understanding Mediating and Moderating Factors That Determine Transfer of Working Memory Training in Adolescents

Обзор

The goal of this clinical trial is to evaluate how different approaches to executive function (like adding game-like features, varying the number of tasks, and providing coaching) can enhance executive function outcomes in adolescents with and without ADHD. The main questions it aims to answer are: * What components of executive function training contribute most to improving outcomes? * How do training components vary in their impacts on adolescents diagnosed with ADHD compared to those without a diagnosis? * What individual characteristics influence the effectiveness of executive function training? Researchers will test six different training setups to examine which setups are the most effective for different people. They will evaluate both how well participants follow the training schedule and whether there are changes in psychological and cognitive outcomes after training. Participants will complete: * 40 training sessions over 4 weeks * A set of tests and surveys before and after the training * Follow-up assessments and surveys 6 months after finishing the training

Вмешательства

• Поведенческое Nongamified N-back training
  This Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes.
• Поведенческое Gamified N-back training
  Participants train on a gamified version of the N-back task, specifically, players control an astronaut that collects resources (target stimuli) needed to feed a colony and keep the technology working, while avoiding non-targets and other obstacles.
• Поведенческое Multiple Domain Training
  Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.
• Поведенческое Nongamified N-back training
  This Single Task Training trains a visual, adaptive N-back task in which participants respond to colors and/or shapes.
• Поведенческое Coaching Session
  Participants in coaching conditions receive weekly, motivational coaching sessions via videoconference to (i) provide encouragement taking into account individual training performance and self-reported engagement (strength-based feedback), (ii) set realistic goals for training (time management, scheduling, and session completion plan, performance goals) while emphasizing autonomy and choice, and (iii) re-explain task and provide corrective feedback as needed.

Первичные конечные точки

• Adherence Composite [Срок оценки: 40 training sessions (weeks 2-5)]
• Working Memory Composite [Срок оценки: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).]
• Inhibition/Flexibility Composite [Срок оценки: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).]

Вторичные конечные точки (3)

• Complex Cognition Composite [Срок оценки: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).]
• Well-Being Composite [Срок оценки: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).]
• Mental Health Composite [Срок оценки: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).]

Критерии участия

Критерии включения

• 12-17 years old.
• Child must have a caregiver (parent/guardian) who is available to participate as a training aide.
• Child and parent/caregiver are able to understand/speak adequate English or Spanish to follow and participate in study procedures
• Both child and parent/guardian are willing to give informed consent/assent, be randomized to either intervention condition, and be willing to follow the assigned study protocol.
• \~50% of the participants: Meet criteria for ADHD DSM-5 diagnosis.

Критерии исключения

• Child is taking ADHD medication/stimulants.
• Child has been formally identified as intellectually disabled.
• Abnormal visual acuity or hearing challenges that are prohibitive to participating in the intervention/assessment.
• History of organic mental disorders (conditions or disturbances that may be caused by injuries and/or neurodegenerative diseases affecting brain tissues), psychosis, history of autism spectrum disorders, intellectual disability, or active substance use or suicidal ideation (such individuals will be referred to psychiatric services).
• Major sensory or motor impairment that would preclude valid cognitive testing.
• Participants with color blindness, if they are unable to discriminate the task relevant stimuli.
• Populations considered vulnerable such as wards and those with neurological or other health conditions that may prevent the ability to give informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Northeastern University — Boston

Идентификаторы

NCT: NCT07147894 · NU-23-05-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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