First Digital Health Application for Children with ADHD Approved by the BfArM in Germany

17.07.2025

MEDICE, the European market leader in the field of ADHD(1), is expanding its intervention options for multimodal ADHD therapy in childhood with hiToco®, a guideline-compliant digital parent training programme that has recently been approved by the BfArM. The Digital Health Application (DiGA) supports parents of children with ADHD aged between 4 and 11 years in their challenging parenting everyday life.

“Parents of children with suspected ADHD or a corresponding diagnosis face major challenges. The family situation is considerably aggravated by waiting times of often several months for appropriate treatment for their children. We can now help these parents in an innovative way by positively influencing parenting behaviour and thereby reducing associated symptoms in the child,” says Dr. med. Katja Pütter-Ammer, Managing Partner of MEDICE.

Parents of children with ADHD report an extreme burden

Parents of children with ADHD experience a higher parenting burden. The reason: children who often display restlessness, impulsivity and attention disorders can contribute to depression, anxiety disorders, sleep disorders and burnout-like symptoms in their parents, which in turn negatively affect parenting behaviour and may impact the children's later lives.(2, 3)

Digital therapy is prescribable, reimbursable and easy to use

The DiGA, which has been approved by the BfArM and is therefore both prescribable and reimbursable by health insurance providers, is available immediately and easy to use. The parent training programme is based on the Therapy Program for Children with Hyperkinetic and Oppositional Problem Behaviour (THOP). It consists of interactive modules that build on one another, in which parents can first select their specific everyday problems following a general introduction. Based on this, the appropriate educational content is then delivered step by step to solve these problems.

In addition, the evidence-based solution includes further features such as planning tools, checklists, exercises and routines that promote self-management, reflection, problem-solving and adherence to therapy. The operation of the digital medical device is simple, can be used immediately and thus promotes therapeutic efficiency.

hiToco® with outstanding clinical results

The hiToco® DiGA, now approved by the BfArM and developed by MEDICE together with Prof. Dr. Anja Görtz-Dorten and Prof. Dr. Manfred Döpfner (emeritus), Center for Child and Adolescent Psychotherapy (CEKIP), University Hospital Cologne, achieved significant improvements for both the child and the participating parent in the clinical study published in the European Child & Adolescent Psychiatry journal (4). Compared with a control group, statistically significant and clinically relevant improvements in the child’s problem behaviour and functional impairments were observed after 12 weeks.

Among parents, improvements in parenting competence and reduced parental stress were observed. Particularly noteworthy is that around half of the children whose parents used hiToco® in the study reported noticing a change in their parents’ parenting behaviour, and that more than 70% of these changes were perceived as good or very good. This result underlines that hiToco® addresses the family as a whole system and can therefore make a valuable contribution to the care of affected children and their families.

The DiGA offers multiple areas of application. It can be used as a complement or accompaniment to pharmacotherapy as well as in combination with individual therapy.

“This means that we can even make the DiGA available as a primary therapy. The guidelines clearly describe that psychosocial interventions should be the first choice, particularly in milder cases. We are now essentially bringing these interventions into the home,” explains Dr. Felix Lambrecht (Head of the Therapeutic Unit Mental Health at MEDICE and Managing Director of medigital) when describing the fields of application.

(1) IQVIA Midas, Absatz in Standardeinheiten, Q1/2025

(2) Cheung, K. and J. Theule, Parental psychopathology in families of children with ADHD: A meta-analysis. Journal of Child and Family Studies, 2016. 25: p. 3451-3461.

(3) Schwörer, M. C., Nitkowski, D., Petermann, F. & Petermann, U. (16.12.2019). Belastungserleben von Müttern mit Kindern mit ADHS. Kindheit und Entwicklung, 29(1), 40–51. https://doi.org/10.1026/0942-5403/a000299

(4) Döpfner, M., Görtz-Dorten, A., Häge, A., Handermann, F., Sulprizio, L., Hell-mich, M., Vogel, D., Ruhmann, M., Althen, H., Karus, M. & Banaschewski, T. (27.06.2025). Efficacy of a mobile-based self-directed parent management training for parents of children with attention-deficit/hyperactivity disorder with or without oppositional defiant disorder– a randomized controlled trial. European Child & Adolescent Psychiatry. https://doi.org/10.1007/s00787-025-02799-2