Executive Function Training for Children and Adolescents

Not Applicable

Not yet recruiting

• Conditions: Cognitive Change

• Registration Number: NCT07147894
• Lead Sponsor: Northeastern University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-10-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 780

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence Composite	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Complex Cognition Composite	pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).	A composite across the following measures will be computed. (1) Fluid Intelligence will be measured with the UCMRT matrix reasoning task; dependent variable: number of correct responses. (2) Quantitative Skills will be assessed through a basic arithmetic task where participants quickly answer addition, subtraction multiplication, and division questions; dependent variable: number of correct responses. Finally, we test (3) Reading Speed will be assessed through a basic where short stories are read, and participants answer comprehension at the end of each passage; dependent variable: composite score of time to complete the task and number of correct responses.
Well-Being Composite	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 standardized surveys to assess self-perceived stress and quality of life will be used.
Mental Health Composite	pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).	A composite across standardized surveys that capture ADHD symptoms will be used across the full sample; in addition, we will assess functional outcomes in the ADHD sample.

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States