An Open-Label Study of a Wearable Device Targeting ADHD, Executive Function, and Academic Performance
Abstract
:1. Introduction
2. Materials & Methods
2.1. Subjects
2.2. Measures
2.2.1. ADHD
2.2.2. Executive Function
2.2.3. Functional Impairment
2.2.4. Academic Performance
2.3. Procedures
2.4. Digital Treatment
2.5. Statistical Analysis
3. Results
3.1. Device Compliance
3.2. Participants
3.3. Symptom Change
3.4. Executive Function
3.5. Functional Impairment and Academic Performance
4. Discussion
Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Demographic | Parent | Teacher | |||
---|---|---|---|---|---|
Age (in years) | N | % | N | % | |
8 | 2 | 5.3 | 1 | 3.8 | |
9 | 8 | 21.1 | 6 | 23.1 | |
10 | 8 | 21.1 | 3 | 11.5 | |
11 | 10 | 26.3 | 9 | 34.6 | |
12 | 10 | 26.3 | 7 | 26.9 | |
M (SD) | 10.5 (1.2) | 10.5 (1.3) | |||
Gender | Boys | 26 | 68.4 | 20 | 77 |
Girls | 12 | 31.6 | 6 | 23 | |
U.S. Race/Ethnicity | % Hispanic | 3 | 8 | 1 | 4 |
Asian | 1 | 3 | 1 | 3.8 | |
Black | 4 | 11 | 2 | 7.7 | |
White | 30 | 79 | 20 | 76.9 | |
Other | 3 | 8 | 3 | 11.6 | |
Parental Education Level | High school graduate/GED | 1 | 2.6 | 0 | 0 |
Some college or associate’s degree | 9 | 23.7 | 8 | 31 | |
Bachelor’s degree or higher | 28 | 73.7 | 18 | 69 | |
ADHD Diagnosis | ADHD Inattentive | 14 | 36.8 | 9 | 35 |
ADHD Hyperactive/Impulsive | 3 | 7.9 | 3 | 11 | |
ADHD Combined | 18 | 47.4 | 13 | 50 | |
Don’t Know | 3 | 7.9 | 1 | 4 | |
Comorbidity | Anxiety | 8 | 21.1 | 6 | 23.1 |
Autism Spectrum Disorder | 2 | 5.3 | 1 | 3.8 | |
Depression | 2 | 5.3 | 2 | 7.7 | |
ODD | 2 | 5.3 | 2 | 7.7 | |
Tic | 1 | 2.6 | 1 | 3.8 | |
Specific Learning Disability | 24 | 63.2 | 11 | 42.3 | |
Total | 38 | 100 | 26 | 100 |
PARENT N = 38 | |||||||||
---|---|---|---|---|---|---|---|---|---|
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
ADHD-RS-5 | |||||||||
Inattention | 20.31 (4.8) | 13.71 (6.3) | 6.6 (6.2) ** | 4.6|8.6 | 6.603 | <0.001 | 1.07 | 0.67|1.5 | 58% |
Hyperactivity/Impulsivity | 12.95 (6.3) | 9.18 (5.8) | 3.77 (5.3) ** | 2.0|5.5 | 4.336 | <0.001 | 0.70 | 0.34|1.0 | 58% |
ADHD Total Score | 33.26 (8.5) | 22.89 (10.3) | 10.37 (10.3) ** | 7.0|13.7 | 6.204 | <0.001 | 1.01 | 0.61|1.4 | 58% |
CONNERS 4—SHORT | |||||||||
Inattention/Executive Dysfunction | 73.63 (6.7) | 62.55 (9.4) | 11.08 (9.1) ** | 8.1|14.1 | 7.458 | <0.001 | 1.21 | 0.78|1.6 | 76% |
Hyperactivity | 67.5 (11.9) | 59.34 (9.0) | 8.16 (8.8) ** | 5.3|11.0 | 5.721 | <0.001 | 0.93 | 0.54|1.3 | 63% |
Impulsivity | 65.63 (12.9) | 57.08 (11.1) | 8.55 (10.2) ** | 5.2|11.9 | 5.164 | <0.001 | 0.84 | 0.46|1.2 | 61% |
Emotional Dysregulation | 63.79 (13.5) | 58.95 (13.5) | 4.84 (8.9) ** | 1.9|7.8 | 3.343 | 0.002 | 0.54 | 0.20|.88 | 47% |
Schoolwork | 70.42 (10.1) | 59.66 (10.2) | 10.76 (9.8) ** | 7.5|14.0 | 6.754 | <0.001 | 1.10 | 0.69|1.5 | 71% |
Peer Interactions | 61.82 (14.0) | 56.11 (13.2) | 5.71 (11.0) ** | 2.1|9.3 | 3.201 | 0.003 | 0.52 | 0.18|.85 | 55% |
Family | 62.68 (13.3) | 58.42 (14.3) | 4.26 (10.8) | .71|7.8 | 2.429 | 0.02 | 0.39 | 0.06|.71 | 47% |
TEACHER N = 26 | |||||||||
---|---|---|---|---|---|---|---|---|---|
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T/Z) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
ADHD-RS-5 | |||||||||
Inattention | 15.08 (8.0) | 11.65 (7.3) | 3.43 (6.3) ** | 0.85|6.0 | 2.746 (T) | 0.011 | 0.54 | 0.12|0.95 | 38% |
Hyperactivity/Impulsivity | 7.81 (8.1) | 6.19 (6.4) | 1.62 (4.2) | −0.10|3.3 | −1.72 (Z) | 0.085 | −0.34 | −0.61|0.02 | 35% |
ADHD Total Score | 22.88 (14.0) | 17.85 (12.1) | 5.03 (8.3) ** | 1.7|8.4 | −2.911 (Z) | 0.004 | −0.57 | −0.80|0.25 | 35% |
CONNERS 4—SHORT | |||||||||
Inattention/Executive Dysfunction | 64.19 (12.7) | 58.62 (10.3) | 5.57 (9.28) ** | 1.83|9.33 | 3.063 (T) | 0.005 | 0.60 | 0.18|1.01 | 50% |
Hyperactivity | 55.27 (13.9) | 53.23 (11.4) | 2.04 (7.5) | −1.0|5.1 | −1.369 (Z) | 0.171 | −0.27 | −0.66|0.02 | 35% |
Impulsivity | 56.85 (11.8) | 53.31 (8.3) | 3.54 (7.94) | 0.33|6.74 | 2.274 (T) | 0.032 | 0.45 | 0.04|0.84 | 38% |
Emotional Dysregulation | 51.12 (10.5) | 50.96 (10.7) | 0.16 (6.8) | −2.6|2.9 | −0.159 (Z) | 0.874 | −0.03 | −0.44|−0.01 | 12% |
Schoolwork | 60.12 (12.8) | 56.31 (10.6) | 3.81(9.5) | −0.03|7.6 | −2.025 (Z) | 0.043 | −0.40 | −0.62|−0.02 | 31% |
Peer Interactions | 54.73 (12.8) | 53.77 (8.9) | 0.95 (10.8) | −3.4|5.3 | −0.334 (Z) | 0.739 | −0.07 | −0.43|−0.01 | 23% |
Family | - | - | - | - | - | - | - | - | - |
Focus Rate % Mean (SD) | Mean Change from Baseline | % Increase over Baseline | Z | p | r | |
---|---|---|---|---|---|---|
Baseline | 48.37 (19.85) | |||||
Week 1 | 56.11 (23.00) | 7.74 | 16% | −2.64 | 0.008 | −0.43 |
Week 2 | 62.00 (23.85) | 13.63 | 28% | −3.456 | <0.001 | −0.56 |
Week 3 | 62.24 (25.61) | 13.87 | 29% | −3.119 | 0.002 | −0.51 |
Week 4 | 61.47 (26.77) | 13.10 | 27% | −3.097 | 0.002 | −0.50 |
Attention Span (Minutes) Mean (SD) | Mean Change from Baseline | % Increase over Baseline | Z | p | r | |
---|---|---|---|---|---|---|
Baseline | 10.45 (18.73) | |||||
Week 1 | 10.34 (9.53) | −0.11 | −1% | −1.798 | 0.072 | −0.29 |
Week 2 | 13.21 (15.03) | 2.76 | 26% | −2.557 | 0.011 | −0.41 |
Week 3 | 15.16 (18.21) | 4.71 | 45% | −2.745 | 0.006 | −0.45 |
Week 4 | 14.24 (13.76) | 3.79 | 36% | −2.488 | 0.013 | −0.40 |
PARENT N = 38 | |||||||||
---|---|---|---|---|---|---|---|---|---|
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T/Z) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
CEFI | |||||||||
Attention | 74.76 (9.0) | 88.71 (9.2) | −13.95 (9.4) ** | −17|−10.9 | −9.168 (T) | <0.001 | −1.49 | −1.9|−1.0 | 71% |
Emotion Regulation | 85.95 (16.9) | 97 (14.1) | −11.05 (9.8) ** | −14.3|−7.8 | −4.892 (Z) | <0.001 | −0.79 | 0.73|0.87 | 61% |
Flexibility | 82.03 (10.9) | 88.39 (13.1) | −6.36 (10.8) ** | −9.9|−2.8 | −3.624 (T) | <0.001 | −0.59 | −0.93|−0.24 | 47% |
Inhibitory Control | 81.66 (12.1) | 92.68 (11.8) | −11.02 (11.9) ** | −14.9|−7.1 | −4.659 (Z) | <0.001 | −0.75 | 0.61|0.86 | 66% |
Initiation | 71.92 (11.4) | 87.58 (13.5) | −15.66 (11.3) ** | −19.4|−11.9 | −8.556 (T) | <0.001 | −1.39 | −1.8|−0.94 | 87% |
Organization | 71.74 (8.7) | 85.87 (10.4) | −14.13 (10.8) ** | −17.7|−10.6 | −8.06 (T) | <0.001 | −1.31 | −1.7|−0.87 | 79% |
Planning | 78.58 (9.8) | 89.45 (11.2) | −10.87 (9.7) ** | −14.1|−7.7 | −6.884 (T) | <0.001 | −1.12 | −1.5|−0.71 | 68% |
Self-Monitoring | 73.42 (11.3) | 88.66 (13.3) | −15.24 (14.5) ** | −20.0|−10.5 | −6.479 (T) | <0.001 | −1.05 | −1.4|−0.65 | 76% |
Working Memory | 68.74 (10.8) | 87.76 (11.7) | −19.02 (12.2) ** | −23.0|−15.0 | −9.621 (T) | <0.001 | −1.56 | −2.0|−1.1 | 87% |
Full Scale | 73.79 (9.6) | 88.39 (10.8) | −14.6 (10.8) ** | −18.1|−11.1 | −8.36 (T) | <0.001 | −1.36 | −1.8|−0.91 | 79% |
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
---|---|---|---|---|---|---|---|---|---|
CEFI | |||||||||
Attention | 82.08 (14.0) | 89.81 (13.3) | −7.73 (10.7) ** | −12.0|−3.4 | −3.682 | 0.001 | −0.72 | −1.1|−0.28 | 42% |
Emotion Regulation | 97.31 (14.2) | 101.58 (15.4) | −4.27 (13.4) | −9.7|1.1 | −1.628 | 0.116 | −0.32 | −0.71|.08 | 38% |
Flexibility | 85.92 (8.7) | 90.81 (9.7) | −4.89 (8.6) | −8.3|−1.4 | −2.896 | 0.008 | −0.57 | −0.98|−0.15 | 38% |
Inhibitory Control | 90.96 (12.3) | 95.19 (11.4) | −4.23 (11.3) | −8.8|0.34 | −1.906 | 0.068 | −0.37 | −0.77|.03 | 38% |
Initiation | 79.46 (15.0) | 86.04 (14.6) | −6.58 (10.7) ** | −10.9|−2.3 | −3.143 | 0.004 | −0.62 | −1.0|−0.19 | 42% |
Organization | 81.54 (11.9) | 89.15 (12.9) | −7.61 (11.1) ** | −12.1|−3.1 | −3.483 | 0.002 | −0.68 | −1.1|−0.25 | 46% |
Planning | 84.23 (10.8) | 91.31 (10.6) | −7.08 (9.0) ** | −10.7|−3.4 | −4.019 | <0.001 | −0.79 | −1.2|−0.34 | 42% |
Self-Monitoring | 84.46 (11.1) | 92.42 (10.5) | −7.96 (10.0) ** | −12|−3.9 | −4.057 | <0.001 | −0.80 | −1.2|−0.35 | 46% |
Working Memory | 82.62 (14.4) | 90.85 (12.5) | −8.23 (12.6) ** | −13.3|−3.1 | −3.317 | 0.003 | −0.65 | −1.1|−0.22 | 50% |
Full Scale | 83.81 (12.0) | 91.04 (11.8) | −7.23 (10.0) ** | −11.3|−3.2 | −3.691 | 0.001 | −0.72 | −1.1|−0.28 | 35% |
PARENT N = 38 | |||||||||
---|---|---|---|---|---|---|---|---|---|
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T/Z) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
IRS | |||||||||
Relationship with Peers | 3.5 (1.9) | 2.53 (2.0) | 0.97 (2.2) | 0.19|1.7 | 2.516 (T) | 0.017 | 0.43 | 0.08|0.78 | |
Relationship with Siblings | 3.5 (1.9) | 3.13 (1.8) | 0.37 (1.9) | −0.31|1.1 | −0.735 (Z) | 0.46 | −0.13 | 0.01|0.46 | |
Relationship with Parent | 3.84 (1.8) | 2.95 (1.8) | 0.89 (1.7) ** | 0.34|1.4 | −2.888 (Z) | 0.004 | −0.47 | 0.21|0.71 | |
Academic Progress | 4.63 (1.4) | 3.79 (1.7) | 0.84(1.4) ** | 0.37|1.3 | −3.316 (Z) | <0.001 | −0.54 | 0.29|0.75 | |
Family Impact | 3.55 (1.9) | 2.76 (1.7) | 0.79 (1.6) ** | 0.27|1.3 | −2.974 (Z) | 0.003 | −0.48 | 0.19|0.68 | |
Self-esteem | 3.84 (1.8) | 3.08 (1.9) | 0.76(1.7) | 0.21|1.3 | −2.625 (Z) | 0.009 | −0.42 | 0.15|0.66 | |
Overall | 4.63 (1.0) | 3.5 (1.7) | 1.13(1.5) ** | 0.62|1.6 | −3.826 (Z) | <0.001 | −0.62 | 0.39|0.78 | |
Total | 3.78 (1.1) | 3.04 (1.5) | 0.74 (1.1) ** | 0.36|1.1 | 3.939 (T) | <0.001 | 0.64 | 0.29|0.96 | 37% |
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T/Z) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
---|---|---|---|---|---|---|---|---|---|
IRS | |||||||||
Relationship with Peers | 2.5 (1.8) | 1.69 (1.7) | 0.81 (1.8) | 0.08|1.5 | −2.262 (Z) | 0.024 | −0.44 | −0.63|−0.03 | |
Relationship with Teacher | 2.81 (2.3) | 1.69 (1.8) | 1.12 (2.0) | 0.32|1.9 | 2.892 (T) | 0.008 ** | 0.57 | 0.15|0.98 | |
Academic Progress | 3.96 (2.1) | 3.46 (2.1) | 0.50 (1.6) | −0.14|1.1 | −1.584 (Z) | 0.113 | −0.31 | −0.61|−0.01 | |
Classroom Impact | 3 (2.3) | 2.31 (2.3) | 0.69 (2.1) | −0.14|1.5 | −1.752 (Z) | 0.08 | −0.34 | −0.69|−0.03 | |
Self-esteem | 2.23 (2.3) | 1.65 (1.9) | 0.58 (2.5) | −0.43|1.6 | 1.176 (T) | 0.251 | 0.23 | −0.16|0.62 | |
Total | 2.9 (1.7) | 2.16 (1.5) | 0.74 (1.4) | 0.18|1.3 | 2.716 (T) | 0.012 | 0.53 | 0.12|0.94 | 35% |
PARENT N = 38 | |||||||||
---|---|---|---|---|---|---|---|---|---|
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T/Z) | p Value | Effect Size | 95% CI of ES (L|U) | % Responders |
WFIRS—P | |||||||||
Family | 1.05 (0.74) | 0.88 (0.73) | 0.17 (0.46) | 0.01|0.33 | 2.177 (T) | 0.037 | 0.37 | 0.02|0.72 | |
School Learning | 1.83 (0.71) | 1.38 (0.85) | 0.45 (0.67) ** | 0.22|0.67 | −3.469 (Z) | <0.001 | −0.58 | 0.32|0.78 | |
School Behavior | 0.4 (0.41) | 0.25 (0.27) | 0.15 (0.30) ** | 0.04|0.25 | −2.652 (Z) | 0.008 | −0.44 | 0.10|0.64 | |
Life Skills | 1.2 (0.46) | 0.94 (0.44) | 0.26 (0.42) ** | 0.12|0.40 | 3.729 (T) | <0.001 | 0.61 | 0.26|0.96 | |
Self-Concept | 0.95 (0.66) | 0.86 (0.57) | 0.09 (0.46) | −0.06|0.24 | 1.168 (T) | 0.25 | 0.19 | −0.13|0.52 | |
Social Activities | 0.7 (0.58) | 0.58 (0.55) | 0.12 (0.29) | 0.02|0.22 | 2.409 (T) | 0.022 | 0.41 | 0.06|0.75 | |
Risky Activities | 0.33 (0.24) | 0.3 (0.25) | 0.03 (0.19) | −0.03|0.10 | 1.087 (T) | 0.285 | 0.19 | −0.16|0.53 | |
Total | 0.89 (0.36) | 0.7 (0.39) | 0.19 (0.28) ** | 0.09|0.28 | 4.075 (T) | <0.001 | 0.66 | 0.31|1.0 | 37% |
TEACHER N = 26 | ||||||||
---|---|---|---|---|---|---|---|---|
Scale | Mean-Pre (SD) | Mean-Post (SD) | Mean Difference (SD) | 95% CI (L|U) | Test Statistic (T) | p Value | Effect Size | 95% CI of ES (L|U) |
APRS | ||||||||
Academic Success | 20.88 (5.6) | 22.28 (5.6) | −1.4 (3.27) | −2.75|−0.05 | −2.13 | 0.043 | −0.43 | −0.83 |−0.01 |
Impulse Control | 8.2 (1.8) | 8.96 (1.7) | −0.76 (1.66) | −1.45|−0.07 | −2.28 | 0.032 | −0.46 | −0.86|−0.04 |
Academic Productivity | 34.33 (10.1) | 38.5 (10.1) | −4.17 (7.06) ** | −7.15|−1.18 | −2.89 | 0.008 | −0.59 | −1.02|−0.15 |
Total Score | 54.08 (13.5) | 59.31 (13.6) | −5.23 (9.01) ** | −8.87|−1.59 | −2.96 | 0.007 | −0.58 | −0.99|−0.16 |
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Ayearst, L.E.; Brancaccio, R.; Weiss, M.D. An Open-Label Study of a Wearable Device Targeting ADHD, Executive Function, and Academic Performance. Brain Sci. 2023, 13, 1728. https://doi.org/10.3390/brainsci13121728
Ayearst LE, Brancaccio R, Weiss MD. An Open-Label Study of a Wearable Device Targeting ADHD, Executive Function, and Academic Performance. Brain Sciences. 2023; 13(12):1728. https://doi.org/10.3390/brainsci13121728
Chicago/Turabian StyleAyearst, Lindsay E., Richard Brancaccio, and Margaret Danielle Weiss. 2023. "An Open-Label Study of a Wearable Device Targeting ADHD, Executive Function, and Academic Performance" Brain Sciences 13, no. 12: 1728. https://doi.org/10.3390/brainsci13121728