Does body-brain training improve measures of attention in children?
| ISRCTN | ISRCTN59416198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59416198 |
- Submission date
- 18/05/2021
- Registration date
- 24/05/2021
- Last edited
- 11/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cognitive control functions (e.g. attention, working memory, goal-management) dictate our ability to learn and accomplish selected behavioral goals, with deficiencies in these processes found in a range of mental illnesses including ADHD (among others). Cognitive training interventions and physical fitness training are two approaches that have been successfully used to enhance deficient cognitive control abilities across a variety of populations, including children with issues of inattention. Given that each approach has led to improvements in untrained cognitive abilities, the possibility exists that a ‘synergistic’ effect on these abilities may be attainable through the combination of each training approach. Developing such a training tool may realize these synergistic effects in humans while simultaneously providing mechanistic evidence regarding how the process of learning can be augmented using the same approach. For the main study, we propose to utilize a novel video game-based intervention (“Pediatric Body-Brain Trainer”, or pediBBT) that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play to leverage principles of embodied cognition.
Who can participate?
Children between the ages of 7 and 12 years with school or community-based diagnosis of ADHD or parental concerns for inattention attending Neil Cummings Elementary School, where the intervention took place as an after-school program were eligible for participation.
What does the study involve?
All participants will play a game called ‘pediBBT’. Participants are asked to participate in this study 4 days a week for 6-weeks, with each day consisting of 9, 3-minute sessions, with training occurring at Neil Cummings Elementary School as opposed to a clinic or laboratory. A research assistant will monitor participation and provide support and feedback to the parents and children during training. Prior to and after the intervention, children have their attention assessed and parents complete a questionnaire about their child’s inattention. Certain measures will be repeated 1 year after the intervention as well.
What are the possible benefits and risks of participating?
There are no direct benefits or risks associated with participating in this study.
Where is the study run from?
University of California, San Francisco (USA)
When is the study starting and how long is it expected to run for?
January 2018 to December 2020
Who is funding the study?
University of California San Francisco Academic Senate Resource Allocation Program, Neuroscape (USA)
Who is the main contact?
Joaquin A. Anguera, Joaquin.anguera@ucsf.edu
Contact information
Scientific
675 Nelson Rising Lane
San Francisco
94158
United States of America
 ORCID ID |
0000-0002-7216-0674 |
|---|---|
| Phone | +1 4155027322 |
| joaquin.anguera@ucsf.edu |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | ISRCTN59416198_PIS.pdf |
| Scientific title | Does synergistic body-brain training improve distinct measures of attention in children? |
| Study acronym | pediBBT |
| Study objectives | Children with parent-reported attention concerns would benefit from an novel combined cognitive and physical fitness intervention |
| Ethics approval(s) | Approved 24/01/2018, University of California, San Francisco Human Research Protection Program Institutional Review Board (UCSF Office of the Committee on Human Research, Box 1288 490 Illinois Street, Floor 6, San Francisco, CA 94143, USA; +1 415-476-1814; irb@ucsf.edu), ref: 17-23723 |
| Health condition(s) or problem(s) studied | Inattention in children |
| Intervention | Pediatric Body Brain Trainer (pediBBT), was developed for an adult cohort by Drs. Gazzaley and Anguera, and adapted with Dr. Marco’s expertise for a pediatric cohort. pediBBT integrates full body motion capture technology with cardiovascular and cognitive adaptive algorithms into a high-level (art, music, story) 3D video game targeting cognitive and physical fitness goals. Children respond with their hands and feet to cognitive tasks engaging three physical control domains (aerobic, balance, and flexibility). Furthermore, the cognitive and physical demands are completely integrated by the pursuit of a common game reward goal. Thus, the cognitive and physical tasks do not compete for cortical capacity—they work in concert, overcoming a problem in previous studies. pediBBT utilizes personalized and precise titrating of training: in contrast to the majority of cognitive training platforms, pediBBT uses continuous, closed-loop adaptivity to drive game mechanics. This involves rapid performance-based assessment, feedback, reward, and modulated challenges to establish the optimal dynamic interactivity between the player and the game environment. This is a design approach used extensively in our work over the past 10 years. Specifically, participants receive physiological and cognitive feedback on a continual basis by incorporating real-time heart rate data and cognitive performance metrics into the software’s adaptive algorithms to instantly (on the order of milliseconds) titrate the demands and rewards of game play. This ensures that each individual is appropriately challenged and engaged during their training experience. PediBBT uses off-the-shelf Microsoft Xbox Kinect 2™ kinematics and a Garmin™ heart rate monitor to capture heart rate data in real time during game play. These devices are advanced yet affordable consumer-level sensors, facilitating community application quickly and feasibly, yet preserving laboratory-quality registration and metrics. pediBBT modules: There are three pediBBT modules, with each targeting a different aspect of cognitive control: a visual search task for attention (with increasing distraction), a spatial span task for working memory, and a task-switching paradigm targeting goal management abilities. All participants will play pediBBT. Participants are asked to participate in this study 4 days a week for 6-weeks, with each day consisting of 9, 3-minute sessions, with training occurring at Neil Cummings Elementary School as opposed to a clinic or laboratory. A research assistant will monitor participation and provide support and feedback to the parents and children during training. Prior to and after the intervention, children have their attention assessed and parents complete a questionnaire about their child’s inattention. Certain measures will be repeated 1 year after the intervention as well. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | pediBBT |
| Primary outcome measure | 1. Parent report of inattention using the Vanderbilt at baseline and post-intervention (6 weeks later) 2. Objective measure of attention using the Continuous Performance Task (CPT) at baseline and post-intervention (6 weeks later) 3. Objective measure of attention using EEG during the Continuous Performance Task (CPT) at baseline and post-intervention (6 weeks later) |
| Secondary outcome measures | 1. Objective measure of Multitasking using the NeuroRacer Multitasking Assessment at baseline and post-intervention (6 weeks later) 2. Objective measure of Working Memory using the delayed recognition working memory task (AID) at baseline and post-intervention (6 weeks later) 3. Objective measure of Basic Response Time (BRT) using the BRT task at baseline and post-intervention (6 weeks later) 4. Surveys of physical fitness at baseline and post-intervention (6 weeks later) 5. Surveys of general health at baseline and post-intervention (6 weeks later) |
| Overall study start date | 02/01/2018 |
| Completion date | 02/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 27 |
| Key inclusion criteria | 1. Children between the ages of 7 and 12 years 2. School or community-based diagnosis of ADHD or parental concerns for inattention Added 16/11/2021: 3. Had no concerns of ADHD or inattention but were simply interested in participating |
| Key exclusion criteria | 1. Concern for Autism Spectrum Disorder (Social Communication Questionnaire score <15) 2. Prematurity (gestational age <32 weeks) 3. Seizures requiring current medication management, psychosis or mood disorder (as assessed by Behavior Assessment System for Children, Second Edition) |
| Date of first enrolment | 20/01/2018 |
| Date of final enrolment | 20/02/2020 |
Locations
Countries of recruitment
- United States of America
Study participating centres
San Francisco
94080
United States of America
Corte Madera
94925
United States of America
San Rafael
94903
United States of America
Sponsor information
University/education
UCSF Office of the Committee on Human Research
675 Nelson Rising Ln
San Francisco
94158
United States of America
| Phone | +1 4154761814 |
|---|---|
| irb@ucsf.edu | |
| Website | https://www.ucsf.edu/ |
"ROR" |
https://ror.org/043mz5j54 |
Funders
Funder type
University/education
No information available
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- UC San Francisco, University of California San Francisco, Toland Medical College, The Medical Department of the University of California, UCSF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Joaquin.Anguera@ucsf.edu). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/06/2021 | No | Yes | ||
| Protocol file | 16/08/2022 | No | No | ||
| Results article | 12/04/2023 | 11/09/2023 | Yes | No |
Additional files
- ISRCTN59416198_PIS.pdf
- Uploaded 01/06/2021
- 39914 Protocol.pdf
Editorial Notes
11/09/2023: Publication reference added.
10/01/2023: The intention to publish date was changed from 07/01/2022 to 31/03/2023.
16/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
13/12/2021: The intention to publish date was changed from 31/12/2021 to 07/01/2022.
16/11/2021: The inclusion criteria were updated.
13/07/2021: The intention to publish date was changed from 09/01/2021 to 31/12/2021.
01/06/2021: The participant information sheet has been uploaded as an additional file.
21/05/2021: Trial's existence confirmed by UC San Francisco.
