protocolSection identificationModule nctId: NCT06270732, orgStudyIdInfo id: PID2021-125444OB-100-II-iM, briefTitle: Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population., acronym: iMentalize, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-02-21, completionDateStruct date: 2025-03-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universitat Autonoma de Barcelona, class: OTHER, collaborators name: Ministerio de Economía y Competitividad, Spain, descriptionModule briefSummary: OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efﬁcacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:* iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).* iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).* MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group)., conditionsModule conditions: Emotional Intelligence, conditions: Social Interaction, conditions: Mental Health Wellness 1, conditions: Well-Being, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, parallel group, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: iMentalize Program (iMentalize), interventions name: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA), interventions name: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU), outcomesModule primaryOutcomes measure: Parental Reﬂective Function Questionnaire (PRFQ), primaryOutcomes measure: Trait Meta-Mood Scale (24 items) (TMMS-24), primaryOutcomes measure: Basic Empathy Scale (BES), primaryOutcomes measure: Movie for the Assessment of Social Cognition (MASC), primaryOutcomes measure: Stirling Children's Wellbeing Scale (SCWBS), primaryOutcomes measure: Child Well-Being Level (CWBL), primaryOutcomes measure: Strengths and Difﬁculties Questionnaire (SDQ), primaryOutcomes measure: Achenbach System for Empirically Assessment (ASEBA), secondaryOutcomes measure: Observing Mediational Interaction (OMI), secondaryOutcomes measure: Parental Stress Questionnaire (PSI), secondaryOutcomes measure: Goldberg Health Questionnaire (28 items) (GHQ-28), secondaryOutcomes measure: Difﬁculties in Emotional Regulation Scale (DERS), secondaryOutcomes measure: Oxford Happiness Questionnaire (OHQ), secondaryOutcomes measure: Rosenberg's Self-Esteem Scale (RSES), secondaryOutcomes measure: Parental Sense of Competence Scale (PSOC), secondaryOutcomes measure: Self-Other Mentalization Scale (SOMS), secondaryOutcomes measure: Reﬂective Functioning Scale - Youth (5 items version) (RFQ-Y5), secondaryOutcomes measure: Trait Meta-Mood Scale - Children version (TMMS-C), secondaryOutcomes measure: Big Five Questionnaire for Children and Adolescents (BFQ-NA), secondaryOutcomes measure: BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn), secondaryOutcomes measure: Rosenberg's Self-Esteem Scale - Child version (RSES-C), secondaryOutcomes measure: Battery of Socialization (BAS), otherOutcomes measure: Inventory of Learning Patterns, reduced version (60 items) (ILP-60), otherOutcomes measure: Relationship Questionnaire (RQ), otherOutcomes measure: Time with the Child (TC), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sergi Ballespí, status: RECRUITING, city: Barcelona, zip: 08193, country: Spain, contacts name: Anna Ciraso, Researcher, role: CONTACT, phone: +34661858272, email: anna.ciraso@uab.cat, contacts name: Ana Carolina Pacheco, Researcher, role: CONTACT, phone: +573153561564, email: anacarolina.pacheco@autonoma.cat, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Universitat Autònoma de Barcelona, status: RECRUITING, city: Barcelona, zip: 08193, country: Spain, contacts name: Anna Ciraso, Researcher, role: CONTACT, phone: +34661858272, email: anna.ciraso@uab.cat, contacts name: Ana Carolina Pacheco, Researcher, role: CONTACT, phone: +573153561564, email: anacarolina.pacheco@autonoma.cat, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False