NCT07147894 · Northeastern University
Executive Function Training for Children and Adolescents
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Nongamified N-back training
This Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes.
BEHAVIORAL
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.
BEHAVIORAL
Multiple Domain Training
Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.
BEHAVIORAL
Nongamified N-back training
This Single Task Training trains a visual, adaptive N-back task in which participants respond to colors and/or shapes.
BEHAVIORAL
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.
Primary outcome measures
Adherence Composite
Time frame: 40 training sessions (weeks 2-5)
An Adherence Composite will be an aggregate score between (1) Participant compliance assessed by the number of completed training sessions completed within guidelines. For each completed training session that complies with the schedule, participants will receive one point, for a total of 40 possible points; (2) Self-reported engagement: After each training session, children are asked to rate their level of engagement using a Likert scale. The dependent variable will be the average engagement rating across all completed sessions; and (3) Effort, which is assessed by fitting a curve to daily training performance with 1 point given for each session where performance is at or above 0.5 SD of the daily estimate for a total of 40 possible points. Furthermore, after each training session, children are asked to rate their level of effort put into the training using a visualized Likert scale. All adherence measures will be combined across all the measures to compute a composite score.
Working Memory Composite
Time frame: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).
A composite score across 3 working memory measures will be computed. (1) Spatial working memory span is a game-like version of the Corsi-blocks task to assess visuospatial working memory; dependent variable: maximum span length. (2) Complex working memory span is similar to Spatial working memory span but also includes a sorting task in-between encoding trials; dependent variable: maximum span length. In (3) Letter-Number Sequencing, participants are presented with a series of intermixed stimuli (e.g., letters and numbers) and recall each stimulus category separately in numerical/alphabetical order; dependent variable: maximum span length.
Inhibition/Flexibility Composite
Time frame: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).
A composite score across inhibitory control/set-shifting measures will be computed. (1) Continuous performance task, modeled after standard measures; dependent variable: hits minus false alarms. (2) Flanker task: classic flanker task; dependent variable: a score based upon speed and accuracy. (3) Rule Switch task a standard switching task; dependent variable: is a score based upon speed and accuracy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations