Conclusions
MH, MLD
SECONDARY, RECRUITMENT, MLD
In its first practical use in an RCT, a psychoedcuational app for parents of children with crying, sleeping, and feeding problems contributes to parents’ better understanding of their child’s symptoms, has the potential to take the edge off parenting stress, and could therefore also serve as an effective secondary preventive measure. It can be recommended by pediatricians, gynecologists, maternity clinics, or child welfare services as an initial low-threshold information and support service when the first symptoms are developing, or it can be used to bridge waiting times for professional counseling appointments. In the future, the app will be made available free of charge as a low-threshold offer.The authors would like to thank all participants in the study for their time and effort. They would like to thank the outpatient clinic, especially Dominika Hess, for their recruitment support; the project staff Katharina Richter, Anne-Sophie Wenzel, Sinja Schwarzwälder, Catherine Buechel, Lena Wagner, and Kristina Scherer for their contributions to the study; and Paula Kuper and Lea Schuurmans for their contributions to the analyses.This study was funded by the initiative “Gesund.Leben.Bayern” of the Bavarian Ministry of Health (grant LP00261).Authors' Contributions: MA, AF, MLD, DW, and VM conceptualized and designed the study. MA and AF coordinated data collection. MA, MH, DDE, AF, MLD, and LDB contributed to the analyses and interpretation of the data. MA, AF, and MH wrote the manuscript. MLD, VM, DW, LDB, AB, and MZ reviewed and revised the manuscript for important intellectual content. AF, MLD, MA, DW, LDB, AB, VM, and MZ developed the app used in the trial. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.Conflicts of Interest: DDE reports to have received consultancy fees or served on the scientific advisory board from several companies such as Novartis, Sanofi, Lantern, Schön Kliniken, Minddistrict, and German health insurance companies (BARMER, Techniker Krankenkasse). DDE and MH are stakeholders of the Institute for Health Trainings Online (GET.ON), which aims to implement scientific findings related to digital health interventions in routine care. MH is an employee of the Institute for Health Trainings Online (GET.ON). AF, MLD, MA, DW, LDB, AB, VM, and MZ developed the app used in the trial.
This randomized study was only retrospectively registered, explained by authors by the fact that at the time of the study’s submission, registration was not yet required by their ethics committee. On recommendation, the study was registered a few months after study initiation and well before any results were obtained. From the start of the study until the time of registration, no fundamental changes to the study design were implemented. The editor granted an exception from ICMJE rules mandating prospective registration of randomized trials. However, readers are advised to carefully assess the validity of any potential explicit or implicit claims related to primary outcomes or effectiveness, as retrospective registration does not prevent authors from changing their outcome measures retrospectively.CONSORT eHEALTH checklist (V 1.6.1).Trial registration.Knowledge test face validity and sensitivity analysis results.