Executive Function Training for Children and Adolescents

NCT ID: NCT07147894

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-14

Study Completion Date

2028-06-30

Brief Summary

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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

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Conditions

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Cognitive Change

Keywords

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ADHD Executive Function Training Motivational coaching Cognitive Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one out of six training conditions. The training conditions are as follows: (1) Nongamified n-Back; (2) Gamified n-Back; (3) Multiple Domain Training; (4) Nongamified n-Back + Motivational Coaching; (5) Gamified n-Back + Motivational Coaching; (6) Multiple Domain Training + Motivational Coaching
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Non Gamified N-back Training

Participants train on a non gamified version of the N-back task.

Group Type EXPERIMENTAL

Nongamified N-back training

Intervention Type BEHAVIORAL

This Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes.

Gamified N-back Training

Participants train on a gamified version of the N-back task.

Group Type EXPERIMENTAL

Gamified N-back training

Intervention Type BEHAVIORAL

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.

Multiple Domain Training

Participants train on N-Back, Complex Span, Set Shifting (Polyrules), and Inhibitory Control.

Group Type EXPERIMENTAL

Multiple Domain Training

Intervention Type BEHAVIORAL

Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.

Non Gamified N-back Training with Coaching

Participants train on a non gamified version of the N-Back task and will receive weekly, motivational coaching sessions via videoconference.

Group Type EXPERIMENTAL

Nongamified N-back training

Intervention Type BEHAVIORAL

This Single Task Training trains a visual, adaptive N-back task in which participants respond to colors and/or shapes.

Coaching Session

Intervention Type BEHAVIORAL

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.

Gamified N-back Training with Coaching

Participants train on a gamified version of the N-back task and will receive weekly, motivational coaching sessions via videoconference.

Group Type EXPERIMENTAL

Gamified N-back training

Intervention Type BEHAVIORAL

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.

Coaching Session

Intervention Type BEHAVIORAL

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.

Multiple Domain Training with Coaching

Participants train on gamified N-back training, Complex Span, Set Shifting, and Inhibitory Control and also receive weekly, motivational coaching sessions via videoconference.

Group Type EXPERIMENTAL

Multiple Domain Training

Intervention Type BEHAVIORAL

Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.

Coaching Session

Intervention Type BEHAVIORAL

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.

Interventions

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Nongamified N-back training

This Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes.

Intervention Type 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.

Intervention Type BEHAVIORAL

Multiple Domain Training

Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Seitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Susanne Jaeggi, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Audrey Carrillo, MA

Role: CONTACT

Phone: (626) 482-8091

Email: [email protected]

Jinlin Liu, MA

Role: CONTACT

Phone: (774) 226-9323‬

Email: [email protected]

Facility Contacts

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Jinlin Liu, MA

Role: primary

Other Identifiers

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NU-23-05-12

Identifier Type: -

Identifier Source: org_study_id