Improvements in objective attention (TOVA API/ACS)with AKL-T01 relate to improvements in academic
performance measures in the STARS-Adjunct trial.

STARS-Adjunct: AKL-T01, a Home-Based Digital Intervention as an
Adjunct to Stimulant Medication for Pediatric ADHD: Academic
Performance and Relation to Objective Measures of Attention
2Naomi Davis, PhD¹; Jacqueline Lutz, PhD ; Scott H. Kollins, PhD¹
Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, NC; 2Akili interactive

CONCLUSIONSRESULTSA previous STARS-ADHD RCT in children, 8-12yo, with ADHD,
without ADHD medication showed:
AKL-T01 significantly improved objective attention (Test ofVariables of Attention, Attention Performance Index TOVA®
API) aﬅer 4 weeks (~ 25 minutes/day, 5 days/week).14*3Improvement

Children who
improved in TOVAACS/API* also
showed improvementin Academic
Performance
Measures aﬅer 1month of AKL-T01.

Improvement

What is the relationship between an
objective measure of attentional functioning
and academic performance measures?

AKL-T01 is a digital treatment designed to improve attentionfunction in ADHD delivered through a video-game interface.

MFaCTS change in children with < or > 0.9
improvement in TOVA ACS/API* aﬅer 1-monthwith AKL-T01

TOSREC change in children with < or > 0.9
improvement in TOVA ACS/API* aﬅer 1-monthwith AKL-T01

210-1

TOSREC Improvement
Mean Change

82187

174

158

126

92
067

4327

1711 N

Academic performance measures (reading:TOSREC², math: MFaCTS³)*TOVA Attention Composite Score (TOVA ACS) is the same as the TOVA
API and reflects a name change in the measure between TOVA V8 andTOVA V9.

ACS/API* Change>= 0.9n=71

Mean ACS/API* change inSTARS-ADHD (0.9)

36REFERENCES

2191

187

6174-3CChildren
hildren withwithgreater
greaterthan
thanXXchangechangeononTOVATOVAACS/API*ACS fromfrom
Baseline
Baselineto
toDay
Day2828(>0(>0meansmeansimprovement)
improvement)

158

126

92
067

43

27

17¹ Kollins et al., A Novel Digital Intervention for

11 N

3Children with greater than X change on TOVA ACS/API* fromBaseline to Day 28 (>0 means improvement)

6

Actively Reducing Severity of Pediatric ADHD(STARS-ADHD): A Randomised Controlled Trial,
The Lancet Digital Health 2, no. 4 (April 1, 2020):
e168–78.

TOSREC

MFaCTS²Wagner et al., TOSREC: Test of Silent Reading
Eﬃciency and Comprehension (Pro-Ed, 2010).
³Reynolds et al., Mathematics Fluency andTOVA ACS/API* andAcademic Performance
Measures weresignificantly andconsistently correlated
at all timepoints.

Academic Measure ValueTOVA ACS/API* objective attention

0Baseline to Day 28

6-3

Academic Measure Value

Endpoints included:

2MFaCTS Improvement

Open-label, 3-month trial (1-month on, 1-month oﬀ, 1-monthon AKL-T01 treatment), across 15 sites (NCT03649074).
Participants
206 children with ADHD, 8-14yo (both medicated and nonmedicated for ADHD).

Gains in TOVA attentionfunctioning with AKL-T01
have the potential toimpact children’s
academic functioning.

8191

METHODSFindings support the clinicalmeaningfulness of TOVA*ACS/API* Change< 0.9n=129

Mean ACS/API* change inSTARS-ADHD (0.9)

Baseline to Day 28

4ACS/API* Change>= 0.9n=71ACS/API* Change< 0.9n=129

The STARS-Adjunct trial explored the eﬀects of repeatedadministration of AKL-T01 in medicated and unmedicatedchildren with ADHD.

MFaCTS Change from Baseline to Day
28 (Mean +/- SE)

Research question

Mean Change

BACKGROUNDTOSREC Change from Baseline to Day 28(Mean +/- SE)1

Calculation Tests Elementary and Secondary(Austin, TX: PRO-ED., 2015).

DISCLOSURESND: received research support from Akili interactive
JL: is employed at Akili interactive and may own stock
options SHK: is consultant, received research supportand may own stock options at Akili interactive