Cognitive ChangeNCT07147894
Executive Function Training for Children and Adolescents
A study testing Nongamified N-back training, Gamified N-back training and Multiple Domain Training in people with Cognitive Change, run by Northeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Nongamified N-back training, Gamified N-back training and Multiple Domain Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Jinlin Liu, MA
Aaron Seitz, PhD
About this study
Official title: Understanding Mediating and Moderating Factors That Determine Transfer of Working Memory Training in Adolescents
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?
Read more
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
- Being tested
- Nongamified N-back training, Gamified N-back training, Multiple Domain Training, Coaching Session
- Keywords
- ADHD, Executive Function Training, Motivational coaching, Cognitive Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nongamified N-back trainingBehavioural
This Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes.
Gamified N-back trainingBehavioural
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 TrainingBehavioural
Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.
Nongamified N-back trainingBehavioural
This Single Task Training trains a visual, adaptive N-back task in which participants respond to colors and/or shapes.
Coaching SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Non Gamified N-back Training | Experimental | Participants train on a non gamified version of the N-back task. Receives: Behavioral: Nongamified N-back training |
| Gamified N-back Training | Experimental | Participants train on a gamified version of the N-back task. Receives: Behavioral: Gamified N-back training |
| Multiple Domain Training | Experimental | Participants train on N-Back, Complex Span, Set Shifting (Polyrules), and Inhibitory Control. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Multiple Domain Training; Behavioral: Coaching Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
A composite score across standardized surveys to assess self-perceived stress and quality of life will be used.
Measured: 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
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.
Measured: pre-test (week 1), post-test (week 6), and 1 follow-up session at least 6 months after post-test (week 30).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start14 Dec 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Seitz, PhD, Principal investigator, Northeastern UniversitySusanne Jaeggi, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147894
- Sponsor's protocol ID
- NU-23-05-12
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (anonymized).
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Mediating and Moderating Factors That Determine Transfer of Working Memory Training in Adolescents
- ClinicalTrials.gov ID
- NCT07147894
- Acronym / sponsor ID
- NU-23-05-12
- Conditions
- Cognitive Change
- Keywords
- ADHD, Executive Function Training, Motivational coaching, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 14 Dec 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Non Gamified N-back Training | Experimental | Behavioral: Nongamified N-back trainingParticipants train on a non gamified version of the N-back task. |
| Gamified N-back Training | Experimental | Behavioral: Gamified N-back trainingParticipants train on a gamified version of the N-back task. |
| Multiple Domain Training | Experimental | Behavioral: Multiple Domain TrainingParticipants train on N-Back, Complex Span, Set Shifting (Polyrules), and Inhibitory Control. |
| Non Gamified N-back Training with Coaching | Experimental | Behavioral: Nongamified N-back training, Behavioral: Coaching SessionParticipants train on a non gamified version of the N-Back task and will receive weekly, motivational coaching sessions via videoconference. |
| Gamified N-back Training with Coaching | Experimental | Behavioral: Gamified N-back training, Behavioral: Coaching SessionParticipants train on a gamified version of the N-back task and will receive weekly, motivational coaching sessions via videoconference. |
| Multiple Domain Training with Coaching | Experimental | Behavioral: Multiple Domain Training, Behavioral: Coaching SessionParticipants train on gamified N-back training, Complex Span, Set Shifting, and Inhibitory Control and also receive weekly, motivational coaching sessions via videoconference. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nongamified N-back trainingThis Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes. | Behavioural | Non Gamified N-back Training |
| Gamified N-back trainingParticipants 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. | Behavioural | Gamified N-back Training, Gamified N-back Training with Coaching |
| Multiple Domain TrainingParticipants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task. | Behavioural | Multiple Domain Training, Multiple Domain Training with Coaching |
| Nongamified N-back trainingThis Single Task Training trains a visual, adaptive N-back task in which participants respond to colors and/or shapes. | Behavioural | Non Gamified N-back Training with Coaching |
| Coaching SessionParticipants 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. | Behavioural | Gamified N-back Training with Coaching, Multiple Domain Training with Coaching, Non Gamified N-back Training with Coaching |
Primary outcome
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.
3 secondary outcomes
Complex Cognition 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).
Well-Being 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).
Mental Health 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. All individual participant data (anonymized).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Seitz, PhD principal investigator
Northeastern University
Susanne Jaeggi, PhD principal investigator
Northeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nongamified N-back training, Gamified N-back training and Multiple Domain Training in people with Cognitive Change, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Carrillo, MA ((626) 482-8091, a.carrillo@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Composite (time frame: 40 training sessions (weeks 2-5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.