Back to resultsDigital Therapy for Treating Attention Deficit Hyperactivity Disorder
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multitask game-based digital therapy
Schulte Grid digital game
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Digital therapy
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.
Sites / Locations
- Children's hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multitask game-based digital therapy
Schulte Grid digital game
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
The ADHD-Rating Scale
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
The ADHD-Rating Scale
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
The ADHD-Rating Scale
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
The Clinical Global Impression Scale - Improvement (CGI-I)
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
The Clinical Global Impression Scale - Improvement (CGI-I)
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
BRIEF Inhibit Percentile
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
BRIEF Inhibit Percentile
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
BRIEF Inhibit Percentile
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Adverse Device Effects
The expectedness of an ADE shall be documented in case Report Form（CRF）. 1. Dizziness,2. Nausea,3. Headache,4. Increased and unusual levels of frustration during game play.
Adverse Device Effects
The expectedness of an ADE shall be documented in case Report Form（CRF）. 1. Dizziness,2. Nausea,3. Headache,4. Increased and unusual levels of frustration during game play.
Full Information
NCT ID
NCT05435651
First Posted
June 23, 2022
Last Updated
August 4, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05435651
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Digital therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multitask game-based digital therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Schulte Grid digital game
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multitask game-based digital therapy
Intervention Description
To practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week.
Intervention Type
Behavioral
Intervention Name(s)
Schulte Grid digital game
Intervention Description
To practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week.
Primary Outcome Measure Information:
Title
the TOVA API
Description
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.
Time Frame
Baseline
Title
the TOVA API
Description
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.
Time Frame
14 days after enrollment
Title
the TOVA API
Description
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.
Time Frame
28 days after enrollment
Secondary Outcome Measure Information:
Title
The ADHD-Rating Scale
Description
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
Time Frame
Baseline
Title
The ADHD-Rating Scale
Description
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
Time Frame
14 days after enrollment
Title
The ADHD-Rating Scale
Description
The ADHD-Rating Scale is an 18-item scale assessing the frequency of each ADHD symptom based on DSM-IV criteria. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.
Time Frame
28 days after enrollment
Title
The Clinical Global Impression Scale - Improvement (CGI-I)
Description
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Time Frame
14 days after enrollment
Title
The Clinical Global Impression Scale - Improvement (CGI-I)
Description
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Time Frame
28 days after enrollment
Title
BRIEF Inhibit Percentile
Description
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Time Frame
Baseline
Title
BRIEF Inhibit Percentile
Description
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Time Frame
14 days after enrollment
Title
BRIEF Inhibit Percentile
Description
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner.
A lower subscale score indicates better ability of working memory.
Time Frame
28 days after enrollment
Title
Adverse Device Effects
Description
The expectedness of an ADE shall be documented in case Report Form（CRF）. 1. Dizziness,2. Nausea,3. Headache,4. Increased and unusual levels of frustration during game play.
Time Frame
14 days after enrollment
Title
Adverse Device Effects
Description
The expectedness of an ADE shall be documented in case Report Form（CRF）. 1. Dizziness,2. Nausea,3. Headache,4. Increased and unusual levels of frustration during game play.
Time Frame
28 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daqian Zhu, PhD
Phone
86-18017590851
Email
zhudaqian2003@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mengyao Li, PhD
Phone
86-13641745122
Email
miyali2@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daqian Zhu, PhD
Organizational Affiliation
Department of Psychological Medicine, Children's Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daqian Zhu
Phone
+8618017590851
Email
zhudaqian2003@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33334505
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.
Results Reference
background
PubMed Identifier
33772095
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.
Results Reference
background
PubMed Identifier
29324745
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.
Results Reference
background
Learn more about this trial
Digital Therapy for Treating Attention Deficit Hyperactivity Disorder
We'll reach out to this number within 24 hrs