STARS-Adjunct: A Home-Based, Digital Treatment for
Pediatric ADHD as Adjunct to Stimulant Medication: Insights
on Repeat Administration and the Stability of Eﬀects
Scott H. Kollins, PhD¹; Andrew Heusser, PhD²; Jacqueline Lutz, PhD²
¹Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, NC,²Akili interactive

Treatment with AKL-T01 showed similar improvements in ADHD-related
symptoms and impairments in children with ADHD whether they were on
stimulants or not on any ADHD medication. Improvements remained
stable during a 4-week treatment pause, and further increased with asecond 4-week AKL-T01 treatment.
ResultsBackground

2. What is the eﬀect of a second treatment month inchildren on and oﬀ stimulant medication?
AKL-T01 is a digital treatment designed to improve attention function inADHD delivered through a video-game interface.

STARS-Adjunct (On Stimulants)

ADHD-related impairment (IRS) Improvement
First Treatment
PeriodFirst Treatment
PeriodSecond Treatment
PeriodSecond Treatment
Period40

5.5

A previous STARS-ADHD RCT found that AKL-T01 improved measures ofobjective attention, ADHD symptoms, and impairment in children
without ADHD medication aﬅer 4-weeks (~ 25 minutes/day, 5 days/week, for 4-weeks).¹

STARS-ADHD RCTSTARS-Adjunct (Both Cohorts)

ADHD symptoms (ADHD-RS Total) Improvement

ADHD-RS Total(Mean +/- SE)

1. What is the eﬀect of combining AKL-T01 with stimulant
medication?

STARS-Adjunct (No Stimulants)

IRS OVerall Severity(Mean +/- SE)

STARS-Adjunct trial goals:

5.0

4.5

ADHD-RS Total
35

IRS

CGI-I
25

Treatment Pause

3.50BL

285684BaselineMean(SD)nChangeMean(SD)nCohen’s dt-statistic
p-value

BaselineMean(SD)n

ChangeMean(SD)n

Cohen’s dt-statistic
p-value32.7(9.8)
130-6.1(7.18)
128.85-9.61<0.00137.0(8.78)
76-7.4(9.92)
74.74
-6.39
<0.0014.8(0.95)
130-0.7(1.04)
128.65-7.38<0.0015.1(.88)76-0.5(.89)
74.59
-5.07
<0.001-3.3(0.84)
128.81-9.14<0.001-3.4(0.83)
74.70
-6.04
<0.001Treatment Pause
0Days

BL28

Days

5684

SafetyNo serious device-related AE. 18% participants experienced anAE, with `decreased frustration tolerance` being the mostcommon (13.1%). 3 AE-related dropouts.

Methods
STARS-Adjunct was an open-label, 3-month trial, across 15 sites (NCT03649074).
Participants: 206 children, m/f, 8-14yo, with ADHD, `On stimulants` or not on any ADHD medication (`No Stimulants`) and ADHD-related impairment (IRS ≥ 3 atBaseline).
FIGURE 01

STARS-Adjunct (No Stimulants)

30

4.0
Primary endpoint

STARS-Adjunct (On Stimulants)

STUDY DESIGNFIGURE 02

Conclusions

SCREENSHOT FROM AKL-T01

Growing body of evidence for AKL-T01 as a digital
therapeutic for attention in ADHD.
Comparable eﬀects across:
ADHD medication status (children on versus oﬀ stimulants)
Trial design (open label versus RCT)

Demographics:
Age Mean (SD)Sex (Male)On Stimulants

No Stimulants

10.6 (1.75)

10.5 (1.82)

98/130 (75.4%) 56/76 (73.7%)

1

REFERENCES

Kollins et al., A Novel Digital Intervention for Actively Reducing Severity of Paediatric ADHD(STARS-ADHD): A Randomised Controlled Trial, The Lancet Digital Health 2, no. 4 (April 1, 2020):
e168–78.

DISCLOSURESSHK is consultant, received research support and may own stock or equity at Akili interactive, ACH andJL are employees at Akili interactive and may own stock or equity at Akili interactive.