A transdiagnostic mentalization-based parenting intervention versus care as usual for parents with mental disorders in adult mental health services in Denmark: protocol for a randomized clinical trial.

Mental disorders can impact parenting negatively, thus placing their children at risk of adversity. The current service support for parents in adult mental health (AMHS) service is limited. The objective of this randomized clinical trial will be to evaluate the effects of a transdiagnostic mentalization-based parenting program (Lighthouse MBT Parenting Program) versus care as usual (CAU) for parents with mental disorders in AMHS in Denmark. This trial is designed as an investigator-initiated single-center open-label randomized clinical superiority trial of the Lighthouse MBT Parenting Program compared to CAU for parents with mental disorders. Participants will be recruited from Danish outpatient mental health clinics by the local service providers and will be included if they have a child 0-17 years of age, whom they are in regular contact with. We plan to randomize 170 parents with a 1:1 allocation ratio stratified by parental gender and baseline parenting stress score. The primary outcome will be level of parenting stress (Parenting Stress Index version 4 - Short Form). Secondary outcomes will be child psychological problems and functioning (Strength and Difficulties Questionnaire - Extended version), parental quality of life (brief abbreviated version of the World Health Organization Questionnaire of Life), family functioning (McMaster Family Assessment Device - General Functioning), exposure to child adversity in offspring (Adverse Child Experiences Questionnaire), parenting competence (Parenting Sense of Competence), parental psychiatric symptom severity (Brief Symptom Inventory), parental health-related quality of life and functioning (European Quality of Life - 5 Dimensions - 3 Levels), and parental use of drugs and alcohol (Alcohol Use Disorders Identification Test and the Drug Use Disorders Identification Test - Extended). The primary and secondary outcomes will be assessed before randomization and at 6, 12, and 24 months after randomization. The primary time-point of assessment will be 6 months after randomization for all randomized participants. Exploratory outcomes include key theoretical concepts, including parental mentalizing (Parental Reflective Functioning Questionnaire), mind-mindedness (representational Mind-Mindedness), and epistemic trust (Epistemic Trust, Mistrust, and Credulity Questionnaire). Exploratory outcomes will be assessed at baseline and at 6 months follow-up. Adverse events will be systematically monitored throughout the trial period using the e-journal system. This trial will provide evidence of the effects of a transdiagnostic mentalization-based parenting intervention (Lighthouse MBT Parenting Program) compared to care as usual for parents with mental disorders in adult mental health services in Denmark. ClinicalTrials.gov: NCT06315114. Registration on 01-03-2024.