protocolSection identificationModule nctId: NCT06315114, orgStudyIdInfo id: p-2023-15049, secondaryIdInfos id: H-23064491, type: OTHER, domain: Regional Committee of Health Research Ethics (VEK), briefTitle: A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders, acronym: LIGHTHOUSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mental Health Services in the Capital Region, Denmark, class: OTHER, collaborators name: University of Copenhagen, descriptionModule briefSummary: The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service., conditionsModule conditions: Mental Disorder, conditions: Behavior Disorders, conditions: Diagnosis, Psychiatric, conditions: Diagnosis Dual, conditions: Severe Mental Disorder, conditions: Mental Illness, conditions: Psychiatric Disorder, conditions: Psychiatric Disease, conditions: Psychiatric Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Lighthouse MBT Parenting Program (LPP), interventions name: Care as usual (CAU), outcomesModule primaryOutcomes measure: Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF), secondaryOutcomes measure: Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ), secondaryOutcomes measure: Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF), secondaryOutcomes measure: Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF)., secondaryOutcomes measure: Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW), secondaryOutcomes measure: Parenting competence assessed with the Parenting Sense of Competence (PSOC), secondaryOutcomes measure: Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI), secondaryOutcomes measure: Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D), otherOutcomes measure: Parental mentalizing assessed with the Parental Reflective Functioning Questionnaire (PRFQ), otherOutcomes measure: Mind-mindedness assessed with the Representational Mind-Mindedness (MM) interview, otherOutcomes measure: Epistemic trust assessed with the Epistemic Trust, Mistrust, and Credulity Ques-tionnaire (ETMCQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Psychotherapeutic Centre Stolpegaard, status: RECRUITING, city: Gentofte, state: Capital Region, zip: 2820, country: Denmark, contacts name: Emilie Hestbaek, role: CONTACT, phone: +4528302849, email: emilie.hestbaek.jacobsen@regionh.dk, geoPoint lat: 55.74903, lon: 12.54601, locations facility: Psychotherapeutic Centre Stolpegård, status: RECRUITING, city: Gentofte, zip: 2820, country: Denmark, contacts name: Emilie Hestbaek, Msc in Psyc, role: CONTACT, phone: +4528302849, email: emilie.hestbaek.jacobsen@regionh.dk, contacts name: Sebastian Simonsen, Doctor, role: CONTACT, email: sebastian.simonsen@regionh.dk, geoPoint lat: 55.74903, lon: 12.54601, hasResults: False