Executive Function Training for Children and Adolescents

Northeastern University

Status: Enrolling

Conditions: Cognitive Change

Treatments: Behavioral: Multiple Domain Training; Behavioral: Coaching Session; Behavioral: Nongamified N-back training; Behavioral: Gamified N-back training

Study type: Interventional

Funder types: Other

Identifiers

NCT07147894

NU-23-05-12

Details and patient eligibility

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. 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

Enrollment: 780 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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780 participants in 6 patient groups

Non Gamified N-back Training

Experimental group

Description:

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

Treatment:

Behavioral: Nongamified N-back training

Behavioral: Nongamified N-back training

Gamified N-back Training

Experimental group

Description:

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

Treatment:

Behavioral: Gamified N-back training

Multiple Domain Training

Experimental group

Description:

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

Treatment:

Behavioral: Multiple Domain Training

Non Gamified N-back Training with Coaching

Experimental group

Description:

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

Treatment:

Behavioral: Nongamified N-back training

Behavioral: Coaching Session

Behavioral: Nongamified N-back training

Gamified N-back Training with Coaching

Experimental group

Description:

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

Treatment:

Behavioral: Gamified N-back training

Behavioral: Coaching Session

Multiple Domain Training with Coaching

Experimental group

Description:

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

Treatment:

Behavioral: Coaching Session

Behavioral: Multiple Domain Training