About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Nongamified N-back training
Behavioral
This Single Task Training is an adaptive N-back task in which participants respond to colors and/or shapes.
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.
Multiple Domain Training
Behavioral
Participants train on a gamified versions of the N-back task, Complex span, Set-shifting and Inhibitory control task.
Nongamified N-back training
Behavioral
This Single Task Training trains a visual, adaptive N-back task in which participants respond to colors and/or shapes.
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.

Treatment groups

780 Participants

are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Non Gamified N-back TrainingExperimental treatment 1 intervention

Group B: Gamified N-back TrainingExperimental treatment 1 intervention

Group C: Multiple Domain TrainingExperimental treatment 1 intervention

Group D: Non Gamified N-back Training with CoachingExperimental treatment 2 interventions

Group E: Gamified N-back Training with CoachingExperimental treatment 2 interventions

Group F: Multiple Domain Training with CoachingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

40 training sessions (weeks 2-5)

2

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.

Time frame