Digital Therapy for Treating Attention Deficit Hyperactivity Disorder

NCT05435651 | Completed

• 1 other identifier: SZLFADHD2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Digital therapy

Outcome Measures

Primary Outcomes (3)

• the TOVA API

  The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.

  Baseline

• the TOVA API

  The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.

  14 days after enrollment

• the TOVA API

  The primary outcome measure was the mean change in The Attention Performance Index (API) of TOVA. The TOVA is a validated, computerised, continuous performance test that objectively measures attention and inhibitory control, normalised by age and sex. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.

  28 days after enrollment

Secondary Outcomes (10)

• The ADHD-Rating Scale

  Baseline

• The ADHD-Rating Scale

  14 days after enrollment

• The ADHD-Rating Scale

  28 days after enrollment

• The Clinical Global Impression Scale - Improvement (CGI-I)

  14 days after enrollment

• The Clinical Global Impression Scale - Improvement (CGI-I)

  28 days after enrollment

Study Arms (2)

Multitask game-based digital therapy

EXPERIMENTAL

Multitask game-based digital therapy group will be asked to practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week. Compliance will be monitored electronically.

Behavioral: Multitask game-based digital therapy

Schulte Grid digital game

ACTIVE COMPARATOR

Schulte Grid digital game group will be asked to practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week. Compliance will be monitored electronically.

Behavioral: Schulte Grid digital game

Interventions

Multitask game-based digital therapy BEHAVIORAL

To practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week.

Multitask game-based digital therapy

Schulte Grid digital game BEHAVIORAL

To practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week.

Schulte Grid digital game

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8 years to 12 years, inclusive, at the time of parental informed consent.
• Male or female.
• Confirmed ADHD diagnosis , any presentation , at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
• Screening/Baseline score on the clinician-rated ADHDRS-IV score 24.
• Screening/Baseline score on the TOVA API -1.8.
• Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening ; or, if undergoing pharmacolog ical treatment , must be willing and appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of current regimen.
• Estimated IQ score\~ 80 as assessed by Wechsler Intelligence Scale for Children-Fourth Edition ,WISC-IV.
• Ability to comply with all the testing and requirements.

You may not qualify if:

• Current, controlled (requiring a restricted medicatio n) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder , psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder , conduct disorder , or other symptomatic manifestatio ns that in the opinion of the Investigator may confound study data/assessments .
• Children who are currently at risk of suicide or have attempted suicide; children who have a history of suicide or are currently exhibiting active suicidal ideation or self-harm.
• Unable to stop taking ADHD medication.
• Motor condition (e.g., physical deformity of the hands/arms ; prostheses) that prevents playing the digital therapy as reported by the parent or observed by the investigator .
• Recent history (within the past 6 months) of suspected substance abuse or dependence.
• History of seizures (exclusive of febr ile seizures) , or significant motor or vocal tics, including but not limited to Tourette 's Disorder.
• Diagnosis of or parent-reported color blindness.
• Uncorrected visual acuity (Confirmed in-clinic via ability of subject to play the game).
• With severe mental retardation.
• Any other medical condition that in the opinion of the investigato r may confound study data/assessments.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (3)

• Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.

  PMID: 33334505 BACKGROUND

• Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. 2021 Mar 26;4(1):58. doi: 10.1038/s41746-021-00429-0.

  PMID: 33772095 BACKGROUND

• Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018 Jan 11;13(1):e0189749. doi: 10.1371/journal.pone.0189749. eCollection 2018.

  PMID: 29324745 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Daqian Zhu, PhD

  Department of Psychological Medicine, Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to Multitask game-based digital therapy or to Schulte Grid digital game control group.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 28, 2022
• Study Start: July 16, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)