Clinical trial NCT05435651: Digital Therapy for Treating Attention Deficit Hyperactivity Disorder
Official title: A Randomized Clinical Trial to Assess The Effectiveness and Safety of Digital Therapy for Treating Attention Deficit Hyperactivity Disorder in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Digital therapy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings.The prevalence in China is estimated to be 6.26%. Front-line intervention for ADHD includes pharmacological and non-pharmacological interventions, which have shown short-term efficacy.There are limitations to current best practices for the treatment of ADHD.

Relating to pharmacotherapy, they are accompanied by adverse events in many children, do not normalize functioning , and adherence rates over time are generally low. Pharmacotherapy may not be suitable for some patients.Relating to non-pharmacological interventions, barriers to access limit the use of non-pharmacological interventions, given a shortage of properly trained paediatric mental health specialists and variability in insurance coverage for such services.

Digital therapy for ADHD may address these limitations with improved access, minimal side-effects, and low potential for abuse.There are studies show that digital intervention can significantly increase attentional functioning of children with ADHD.At present, there are few related researches on digital therapy in China.The total number of ADHD children is large in China, and electronic products are very popular in Chinese families.If digital therapies suitable for ADHD children in China can be developed, it will be of great significance for the promotion of human health.

Therefore, investigators designed the study 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 in China.Safety, tolerability, and compliance were also assessed.

The study will be a blinded (investigators and outcome assessors), randomized, parallel group, follow-up study of the sustained effects of 28 days of treatment with either Multitask game-based digital therapy or Schulte Grid digital game.

The trial will consist of 3 visits: Screening, FU-Day 14 visit and FU-Day 28 visit.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the TOVA API
timeFrame: Baseline
measure: the TOVA API
timeFrame: 14 days after enrollment
measure: the TOVA API
timeFrame: 28 days after enrollment
Secondary outcomes:
measure: The ADHD-Rating Scale
timeFrame: Baseline
measure: The ADHD-Rating Scale
timeFrame: 14 days after enrollment
measure: The ADHD-Rating Scale
timeFrame: 28 days after enrollment
measure: The Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: 14 days after enrollment
measure: The Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: 28 days after enrollment
measure: BRIEF Inhibit Percentile
timeFrame: Baseline
measure: BRIEF Inhibit Percentile
timeFrame: 14 days after enrollment
measure: BRIEF Inhibit Percentile
timeFrame: 28 days after enrollment
measure: Adverse Device Effects
timeFrame: 14 days after enrollment
measure: Adverse Device Effects
timeFrame: 28 days after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Department of Psychological Medicine, Children's Hospital of Fudan University
name: Daqian Zhu, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.