First digital health application for children with ADHD in Germany approved by BfArM

MEDICE, the European market leader in the field of ADHD⁽¹⁾, is expanding its intervention options for multimodal therapy of ADHD in children with a guideline-based digital family coaching programme hiToco®, which is currently approved by the BfArM. The digital health application (DiGA) supports parents of children with ADHD between the ages of 4 and 11 in their challenging day-to-day parenting.

"Parents of children with suspected ADHD or a corresponding diagnosis face major challenges. The family situation is exacerbated considerably by the often months-long wait for professional treatment for their children. We can now help these parents in an innovative way by having a positive effect on parenting behaviour and reducing the child's associated symptoms," says Dr Katja Pütter-Ammer, Managing Partner of MEDICE.

Parents of children with ADHD complain of extreme stress

Parents of children with ADHD have a higher educational burden. This is because the children, who are often restless, impulsive and have attention deficit disorders, can lead to depression, anxiety and sleep disorders as well as burnout-like symptoms in their parents, which in turn have a negative impact on parenting behaviour that can affect the children's later life^{(2, 3)}.

Digital therapy can be prescribed and reimbursed and is easy to use

DiGA, which is approved by the BfArM and can be prescribed and reimbursed by health insurance companies, is immediately available and easy to use. The family coaching is based on the therapy programme for children with hyperkinetic and oppositional problem behaviour (THOP). It consists of interactive modules that build on each other, in which parents can select their specific everyday problems after an initial general introduction. Based on this, the right educational content is then taught step by step to solve these problems.

In addition, the evidence-based solution contains further functions such as planning, checklists, exercises and routines that promote self-management, reflection, problem-solving and adherence to treatment. The digital medical device is easy to use and immediately applicable, thus promoting therapeutic efficiency.

hiToco® with first-class 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 (ret.), Centre for Child and Adolescent Psychotherapy (CEKIP), University Hospital Cologne, achieved significant improvements in both the child and the participating parent in the clinical study published in European Child & Adolescent Psychiatry⁽⁴⁾. Compared to a control group, there were statistically significant and clinically relevant improvements in the child's problem behaviour and functional limitations after 12 weeks.

An improvement in parenting skills and reduced parental stress were observed in the parents. It is particularly noteworthy that around half of the children of parents who used hiToco® in the study reported a change in parental parenting behaviour and that more than 70% of these changes were perceived as good or very good. This result emphasises 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 has multiple application potential. It can be used to supplement or accompany pharmacotherapy and in combination with individualised therapy.

"This means that we can even provide DiGA as a primary therapy. The guidelines clearly state that psychosocial interventions should be the first choice, especially in mild cases, and we are now providing these for use at home, so to speak," says Dr Felix Lambrecht (Head of the Therapeutic Unit Mental Health at MEDICE and Managing Director of medigital), describing the dimensions of use.

(1) IQVIA Midas, Sales in standard units, 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