Document is current

Article History

Received: 3 November 2025

Accepted: 19 February 2026

First Online: 10 March 2026

Declarations

:

: Prior to commencing the trial, approval was obtained from the Regional Ethics Committee and from the Danish Data Protection Agency and Data Protection Act (ID: P-2023-15049). The trial will be conducted in compliance with the official trial protocol, the World Medical Association Declaration of Helsinki [ ], ICH-GCP guidelines [ ], and the European General Data Protection Regulation (GDPR) standards [ ]. There are some potential ethical concerns relevant to this trial. First, participation in research assessments may be a minor burden to the parents. Secondly, as the target population includes parents with a mental disorder, who constitute a high-risk group in terms of child maltreatment, all therapists and on-site members of the research team will receive training in terms of policies and procedures for handling concerns about children’s safety. Third, the interventions are not expected to be associated with any side effects or risk to parents or children. Both the experimental intervention and control intervention follow the clinical guidelines by the Mental Health Services, Capital Region. However, we are aware that participation in parenting-focused interventions for high-risk groups may be emotionally demanding and at times stressful, which could impact our outcome measures. In addition, random allocation of psychiatric patients may result in lack of trust and feelings of abandonment if allocated to an untoward intervention (typically CAU). This could potentially influence their motivation to continue receiving their usual psychiatric treatment and may thus pose a risk of the patients’ dropping out of the research project as well as their standard psychiatric treatment. The consent allows the investigators, sponsor, and representatives of the sponsor, as well as any regulatory authority, direct access to obtain information in the participant’s records, including electronic records, to review details about the participant’s health conditions that are necessary for the implementation of the research project, as well as for monitoring purposes, including self-inspection, quality control, and monitoring that they are obligated to perform. During the trial period, serious adverse events for participating parents will be carefully monitored throughout the trial, and we will assess, document, and report any adverse events to the regional research ethics committee. This committee monitors all reports of serious adverse events from trial sites. Exclusion from the trial only occurs in case of acute serious endangerment of the participant or his/her child. Participants can, at any time, withdraw their consent without any implications for current or future treatment in the Mental Health Service, Capital Region. The trial is covered by patient compensation.

: The authors declare that they have no competing interests.