Clinical trial NCT06270732: Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population.
Official title: Efficacy of iMentalize and Mediational Intervention for Sensitizing Caregivers - Self Administered Version (MISC-SA) to Foster Parents' Mentalization and Children Mental Health in Families From General Population (iMentalize Project).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Intelligence
Social Interaction
Mental Health Wellness 1
Well-Being, Psychological
Keywords: Mentalization
Reflective function
Reflective parenting
Environmental enrichment
Parent-child interaction
Development
Mental Health
Emotional Health
Emotional well-being
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2024-02-21
Enrollment: 105
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, parallel group, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: CONTEXT: Mental health interventions are mostly provided once mental health is lost, that is, in context of psychopathology (i.e., when clinical levels of severity or impairment are reached). James Heckman's Equation suggests that investing in mental health before it is severely impaired would lead to high returns. We want to test: 1) to what extent is possible to transfer active ingredients for mental health from the clinical context to the community, and 2) to what extent an intervention aimed to enrich parents with higher mentalization and interaction skills improves children's mental health. Because this intervention aims to reach a wide community in non-clinical settings, it should be extensive (to ensure solid changes in the child environment) and cost-efﬁcient, that is: cheaper than those individually transmitted in the classic therapist-client relationship.

METHODOLOGY: 12-month multisite, Randomized, Controlled Trial (RCT).

MEASURES OPERATIONALIZATION: It is expected that this translational intervention which aims to move factors for salutogenesis from the clinical setting to the non-clinical range of the mental ill-health continuum could beneﬁt both the caregivers (parents) who receive the intervention and their children, who are daily exposed to them. Caregivers' beneﬁts are expected in terms of improved mentalizing capacities (primary outcome) but also in terms of higher quality interactions, lower stress, lower distress symptoms, higher well-being and higher sense of self- efﬁcacy (secondary outcomes). Child's mental health (primary outcome) is operationalized as multidimensional using: the number of symptoms, the level of role- and social functioning, and well-being. Child's beneﬁts in terms of mentalization and pro-social behavior (secondary outcomes) are also expected because of the long-term exposition to adults enriched with new social-emotional skills based on the intervention. It is expected that parent's interventions could foster children mental health by promoting children mentalization skills (mediational or process variable).

STATISTICAL ANALYSES: The analysis under the Intention-To-Treat (ITT) approach will encompass all participants subjected to random allocation, with the utilization of multiple imputation techniques to address any missing data. Estimation of parameters, accounting for the speciﬁc statistical assumptions of each model and the data's characteristics, will be carried out through the implementation of Linear Mixed-Effect Models and Structural Equation Modeling (SEM). Various R packages will be employed to execute these models, primarily "lme4" and "nlme" for linear mixed-effect models, and "lavaan" for SEM models. Concerning statistical power, a sample size of 105 participants (35 per arm) has been proposed, which exceeds the minimum of 54 participants (18 per arm) required to detect a medium effect size (Cohen's d=0.25) in the design comprising 3 arms, 3 repeated measures (pre, post, and 1 follow-up), and a power level of .95. An empirical power close to 1.00 is anticipated. Effect size measures, including Cohen's d and squared Omega statistics, will be employed.

Eligibility criteria: Inclusion Criteria:

* Parent of a 6 to 18 years old child
* Written informed consent
* Understanding Catalan
* Pre-intervention assessment complete

Exclusion Criteria:

* None

Primary outcomes:
measure: Parental Reﬂective Function Questionnaire (PRFQ)
timeFrame: Through study completion, an average of 12 months
measure: Trait Meta-Mood Scale (24 items) (TMMS-24)
timeFrame: Through study completion, an average of 12 months
measure: Basic Empathy Scale (BES)
timeFrame: Through study completion, an average of 12 months
measure: Movie for the Assessment of Social Cognition (MASC)
timeFrame: Through study completion, an average of 12 months
measure: Stirling Children's Wellbeing Scale (SCWBS)
timeFrame: Through study completion, an average of 12 months
measure: Child Well-Being Level (CWBL)
timeFrame: Through study completion, an average of 12 months
measure: Strengths and Difﬁculties Questionnaire (SDQ)
timeFrame: Through study completion, an average of 12 months
measure: Achenbach System for Empirically Assessment (ASEBA)
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Observing Mediational Interaction (OMI)
timeFrame: Through study completion, an average of 12 months
measure: Parental Stress Questionnaire (PSI)
timeFrame: Through study completion, an average of 12 months
measure: Goldberg Health Questionnaire (28 items) (GHQ-28)
timeFrame: Through study completion, an average of 12 months
measure: Difﬁculties in Emotional Regulation Scale (DERS)
timeFrame: Through study completion, an average of 12 months
measure: Oxford Happiness Questionnaire (OHQ)
timeFrame: Through study completion, an average of 12 months
measure: Rosenberg's Self-Esteem Scale (RSES)
timeFrame: Through study completion, an average of 12 months
measure: Parental Sense of Competence Scale (PSOC)
timeFrame: Through study completion, an average of 12 months
measure: Self-Other Mentalization Scale (SOMS)
timeFrame: Through study completion, an average of 12 months
measure: Reﬂective Functioning Scale - Youth (5 items version) (RFQ-Y5)
timeFrame: Through study completion, an average of 12 months
measure: Trait Meta-Mood Scale - Children version (TMMS-C)
timeFrame: Through study completion, an average of 12 months
measure: Big Five Questionnaire for Children and Adolescents (BFQ-NA)
timeFrame: Through study completion, an average of 12 months
measure: BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)
timeFrame: Through study completion, an average of 12 months
measure: Rosenberg's Self-Esteem Scale - Child version (RSES-C)
timeFrame: Through study completion, an average of 12 months
measure: Battery of Socialization (BAS)
timeFrame: Through study completion, an average of 12 months
Other outcomes:
measure: Inventory of Learning Patterns, reduced version (60 items) (ILP-60)
timeFrame: Through study completion, an average of 12 months
measure: Relationship Questionnaire (RQ)
timeFrame: Through study completion, an average of 12 months
measure: Time with the Child (TC)
timeFrame: Through study completion, an average of 12 months
Locations:
city: Barcelona
country: Spain
facility: Sergi Ballespí
city: Barcelona
country: Spain
facility: Universitat Autònoma de Barcelona
Study officials:
affiliation: Universitat Autònoma de Barcelona
name: Sergi Ballespí, Researcher
role: PRINCIPAL_INVESTIGATOR
References: