Randomised controlled pilot study on the clinical benefit of the smartphone app medigital® ADHD/OPP (powered by eyelevel)

Not Applicable

• Conditions: F90.0; F90.1; F90.8; F90.9; F91.3; F98.80; Disturbance of activity and attention; Hyperkinetic conduct disorder; Other hyperkinetic disorders; Hyperkinetic disorder, unspecified

• Registration Number: DRKS00030086
• Lead Sponsor: Medigital GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-12
• Study Completion: 2024-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Inclusion criteria for all cohorts:

-Child's age: 4;0-11;11 yrs.

-Child shows elevated parent-reported symptom scores on the DISYPS FBB-ADHS (ADHD total) and/or the DISYPS FBB-SSV (oppositional defiant behaviour subscale) at screening, scale scores >1.0.

-The child's symptomatology must occur in the family (clinical judgement)

-Sufficient reading skills and German language skills of the parent using the app and participating in the data collection (clinical judgement)

-Willingness and resources of the parent to actively participate in this study (clinical judgement)

- Written informed consent from the parent/legal guardian and oral/written assent from the child to participate in the study.

-Internet connection in the family’s home, smartphone and PC/notebook or tablet PC.

Inclusion criteria cohort 1 without intensive therapy:

-Child has a confirmed diagnosis of ADHD and/or ODD (ICD-10 diagnosis F90.0, F90.1, F90.8, F90.9, F98.80 and/or F91.3; clinical judgment).

Inclusion criteria cohort 2 suspected diagnosis:

-Child has a suspected diagnosis of ADHD and/or ODD (ICD-10 diagnosis F90.0, F90.1, F90.8, F90.9, F98.80 and/or F91.3; clinical judgment).

Inclusion criteria cohort 3 Pharmacotherapy with residual symptoms:

-Child has a confirmed diagnosis of ADHD prior to initiation of pharmacotherapy (ICD diagnosis F90.0, F90.1, F90.8, F98.80; clinical judgement).

-Stable pharmacotherapy (at least 4 weeks and longer) of the child with an ADHD medication.

Exclusion Criteria

Exclusion criteria all cohorts:

-Child has another severe mental disorder (e.g., intellectual disability, autism, psychosis) (clinical judgement).

-Known severe mental disorder of the parent using the app and participating in data collection (e.g., severe addictive disorder, severe emotionally unstable personality disorder, psychosis) (clinical judgment)

-Inpatient treatment planned due to mental disorder of the child

-Simultaneous or planned use of an ADHD/ODD app within the next 4 months

-Simultaneous participation in other studies or other clinical research projects

-Participation in this study with another child at the same time

Exclusion criteria cohort 1 without intensive therapy:

-ADHD medication or medication for aggressive behaviour (e.g. neuroleptics) of the child, currently ongoing or planned for the next four months (clinical judgement)

-Intensive behavioural therapy of the child due to ADHD/ODD with usually at least 2 contacts per month or regular parent training due to the child's symptoms with usually at least 2 contacts per month in the course of the last 12 months, currently ongoing or planned in the next four months (clinical judgement)

Exclusion criteria cohort 2 suspected diagnosis:

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Exclusion criteria cohort 3 pharmacotherapy with residual symptoms:

-Intensive behavioural therapy of the child due to ADHD/ODD with usually at least 2 contacts per month or regular parent training due to the child's symptoms with usually at least 2 contacts per month, currently ongoing or planned for the next four months (clinical judgement).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of ADHD and ODD: Mean score of the 28 items of the German Fremdbeurteilungsbogen (FBB) DISYPS-III ADHS (part A+B) and SSV (part A, subscale oppositional behaviour) as reported by the parents. Symptom scores will be measures at T0 (week 0), T1 (week 8), T2 (week 12) and T3 (week 16). The primary endpoint will be assessed using the intent-to-treat (ITT) approach.

Secondary Outcome Measures

Name	Time	Method
1) ADHD symptoms: DISYPS III FBB-ADHS (ADHD total scale, parent-report)<br><br>2) ODD symptoms: DISYPS III FBB-SSV (ODD scale, parent-report) <br><br>3) Positive/negative parenting behaviour (FPNE, parent-report)<br><br>4) Parental stress (FSI, parent-report)<br><br>5) Safety (adverse events, device deficiencies)<br><br>Questionnaire data will be collected at T0 (week 0), T1 (week 8), T2 (week 12) and T3 (week 16). Adverse events and device deficiencies will be recorded throughout the study.