DRKS00030086
Completed
N/A
Randomised controlled pilot study on the clinical benefit of the smartphone app medigital® ADHD/OPP (powered by eyelevel)
Medigital GmbH0 sites139 target enrollmentSeptember 12, 2022
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- F90.0
- Sponsor
- Medigital GmbH
- Enrollment
- 139
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
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)
Outcomes
Primary Outcomes
Not specified
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