Executive Function Training for Children and Adolescents

NCT07147894 | Recruiting

• 1 other identifier: NU-23-05-12
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Change

Keywords

ADHD; Executive Function Training; Motivational coaching; Cognitive Training

Outcome Measures

Primary Outcomes (3)

• Adherence Composite

  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.

  40 training sessions (weeks 2-5)

• Working Memory Composite

  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.

  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

  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.

  pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).

Secondary Outcomes (3)

• 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).

• 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).

• 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).

Other Outcomes (2)

• Control Measures

  pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).

• Near Transfer

  pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).

Study Arms (6)

Non Gamified N-back Training

EXPERIMENTAL

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

Behavioral: Nongamified N-back training

Gamified N-back Training

EXPERIMENTAL

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

Behavioral: Gamified N-back training

Multiple Domain Training

EXPERIMENTAL

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

Behavioral: Multiple Domain Training

Non Gamified N-back Training with Coaching

EXPERIMENTAL

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

Behavioral: Nongamified N-back training; Behavioral: Coaching Session

Gamified N-back Training with Coaching

EXPERIMENTAL

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

Behavioral: Gamified N-back training; Behavioral: Coaching Session

Multiple Domain Training with Coaching

EXPERIMENTAL

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

Behavioral: Multiple Domain Training; Behavioral: Coaching Session

Interventions

Gamified N-back training 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.

Gamified N-back Training; Gamified N-back Training with Coaching

Multiple Domain Training BEHAVIORAL

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

Multiple Domain Training; Multiple Domain Training with Coaching

Coaching Session 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; Multiple Domain Training with Coaching; Non Gamified N-back Training with Coaching

Nongamified N-back training BEHAVIORAL

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

Non Gamified N-back Training

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aaron Seitz, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

• Susanne Jaeggi, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey Carrillo, MA

CONTACT

(626) 482-8091; a.carrillo@northeastern.edu

Jinlin Liu, MA

CONTACT

(774) 226-9323‬; jinl.liu@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: December 14, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will be available persistently at the conclusion of the study.
• Access Criteria: There are no access criteria.

Locations

US (1)