Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population.

Mental Health Wellness 1 Clinical Trial

— iMentalize  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270732
• Other study ID #: PID2021-125444OB-100-II-iM
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: March 3, 2025

Study information

• Verified date: February 2024
• Source: Universitat Autonoma de Barcelona
• Contact: Anna Ciraso, Researcher
• Phone: ++34661858272
• Email: anna.ciraso[@]uab.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 3, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Parent of a 6 to 18 years old child

• Written informed consent

• Understanding Catalan

• Pre-intervention assessment complete

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Emotional Intelligence
• Mental Health Wellness 1
• Social Interaction

Intervention

Behavioral:
• iMentalize Program (iMentalize)
This is a 30-hour group training involving 30 sessions lasting 45 minutes and 7.5 hours of inter-sessions work. Session 1: Program presentation; Session 2: Reflective Parenting; Session 3: Cartoon's session I (baseline); Session 3: What is Mentalization; Session 4: Fundamentals of Human Interaction; Session 5: Cartoon's session II (the beginnings); Session 6: Mentalization and Mental Health; Session 7: MISC context and cultural components; Session 8: Cartoon's session III (practice with MISC context comp.); Session 9: The importance of emotions in human interaction; Session 10: MISC emotional components; Session 11: Cartoon's session IV (practice with emotional comp.); Session 11: How mentalization is developed; Session 12: MISC cognitive components; Session 13: Cartoon's session V (practice with cognitive comp.); Session 14: How to foster children mentalization skills. Sessions 15 to 30: Cartoon's sessions using MISC components to foster children mentalization.
• Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)
This is a 30-hour individual training involving 30-weekly online, individual, self-administered 45' sessions (22.5h) + 7.5h of between sessions work (readings, supervision, video- recordings for later video-feedback, re?ection exercises). BLOCK I: Session 1: Presentation of the MISC program; Sessions 2 to 8 (Self-Administered or SA): Theoretical bases of the MISC; Sessions 9-18 (MISC practice and video-feedback); Summer break: Recording daily life interactions; BLOCK II: Session 19: Recap; Sessions 20-30: guided re?ection and video-feedback.
• Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)
This is an equivalent 30-hour online self-administered training involving 30 x 45' individual online sessions (22.5h), mostly based on re?ection exercises around brief readings, pills, and animated shorts, but not video- feedback and guided practice. This is complemented with 7.5h of between-sessions work based on looking for new information, adult-child (non-guided) activities (and not for later video- feedback) or out-of-line guided re?ective exercises. Session 1: Program presentation; Session 2-8: Theoretical bases of MISC and mentalization; Session 9-16: MISC and mentalization applied to mental health; 17-18: Benefits of MISC to improve children learning; 19-20: Benefits of MISC for self-esteem; 21-22: The importance of MISC to foster mentalization; 23-24: Mentalization and pro-social behavior; 25-26: The importance of MISC to promote secure attachment; 27: MISC impact in epistemic trust; 28-29: MISC and well-being; 30: MISC, mentalization and environmental enrichment.

Locations

Country	Name	City	State
Spain	Sergi Ballespí	Barcelona
Spain	Universitat Autònoma de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Autonoma de Barcelona	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inventory of Learning Patterns, reduced version (60 items) (ILP-60)	This instrument measures learning patterns, which are considered to moderate the impact of the intervention. It consists of 60 items evaluating 4 learning components (processing strategies, regulation strategies, conceptions of learning, learning orientations) with 15 x 5-point Lickert scale items each. All scales range from 15 to 75. A higher score means a higher presence of that component or a higher tendency to use that pattern (potential moderator).	Through study completion, an average of 12 months
Other	Relationship Questionnaire (RQ)	This is a very brief screening scale including 4 x 7-point Lickert's to assess the 4 Bartholomew and Horowitz's relationship styles (secure, anxious-avoidant, anxious-preoccupied and disorganized) and 1 last categorical item to select the style that better identi?es the participant. Attachment style could moderate the impact of parental intervention on a child's mental health. Each attachment style is scored from 1 to 7. A higher score indicates a higher presence of that relationship style (potential moderator).	Through study completion, an average of 12 months
Other	Time with the Child (TC)	This is an ad hoc scale to calculate the amount of real time of interaction (communication and reciprocal influence) with the child in daily minutes, across 1 week (from Monday to Sunday). It ranges from 0 to several hours. A higher score means more time for real interaction with the child (in minutes) per day or per week. This is used as a measure of exposure to the "enriched" parenting (potential moderator).	Through study completion, an average of 12 months
Primary	Parental Re?ective Function Questionnaire (PRFQ)	This scale assesses parent capacity to mentalize the child (to keep the child's mind in mind) using 18 items scored from 1 (Completely disagree) to 7 (Completely agree). Total score ranges from18 to 126. A higher score indicates higher re?ective parenting (better outcome).	Through study completion, an average of 12 months
Primary	Trait Meta-Mood Scale (24 items) (TMMS-24)	This instrument consists of 3 x 8-tiem subscales ('attention to emotions', 'emotional clarity' and 'emotional repair') scored with a 5- point scale ranging from "1=totally disagree" to "5=totally agree". Each scale ranges 8-40. A higher score means higher meta- mood knowledge (better outcome).	Through study completion, an average of 12 months
Primary	Basic Empathy Scale (BES)	This is a gold standard to assess empathy and consists of 20 items scored from 1 (totally disagree) to 5 (totally agree). Total score ranges from 20 to 100. A higher score is indicative of higher empathy (better outcome).	Through study completion, an average of 12 months
Primary	Movie for the Assessment of Social Cognition (MASC)	The MASC consists of a 15-minute video stopping in 46 segments or items to assess adequate mentalizing, hyper-mentalizing, hypo-mentalizing or non-mentalizing. All scales range from 0 to 46. A higher score in adequate mentalizing indicates higher mentalizing capacity (better outcome). A higher score in the other 3 subscales indicates worse mentalizing capacity.	Through study completion, an average of 12 months
Primary	Stirling Children's Wellbeing Scale (SCWBS)	This is a 15-item scale commonly used to measure children's happiness in the last 2 weeks. Items are scored from 1 (Never) to 5 (all the time). The score ranges from 15 to 75. A higher score means more happiness (better outcome).	Through study completion, an average of 12 months
Primary	Child Well-Being Level (CWBL)	This is Lickert's 7-point scale to assess the child's level of happiness compared with other children of the same age. It ranges from '1=very less happy' to '8=very happier'. A higher score means more happiness (better outcome).	Through study completion, an average of 12 months
Primary	Strengths and Dif?culties Questionnaire (SDQ)	This is a 25 item-based scale, scored using a 3-points scale (0=not true; 2=certainly true) which provides a screening of 5 dimensions: children emotional problems, conduct problems, hyperactivity, peer-problems and pro-social behavior. All scales range from 0 to 10. A higher score means more problems (?rst 4 scales: worse outcome) or more pro-social behavior (last subscale: better outcome).	Through study completion, an average of 12 months
Primary	Achenbach System for Empirically Assessment (ASEBA)	This is a very well-known 110 items-based instrument scored from 0=Not true to 2=Very often true which provides a screening in 8 clinical dimensions and 3 second order scales. Each scale has a different range. Higher scores mean higher severity of mental health problems (worse outcome).	Through study completion, an average of 12 months
Secondary	Observing Mediational Interaction (OMI)	This is the observational measure used in the Mediational Intervention for Sensitizing Caregivers (MISC) and quanti?es emotional (attachment-based) and cognitive (learning-based) behaviors during caregiver-child interaction. The emotional components scale ranges from 0 to 40. A higher score indicates more emotional components. Cognitive components (Focusing, Affecting, Expanding, Regulating, Rewarding) are evaluated based on their frequency along the interaction. A higher score means more frequency of those components (better outcome).	Through study completion, an average of 12 months
Secondary	Parental Stress Questionnaire (PSI)	This instrument consists of 36 items scored from 1 (very agree) to 5 (very disagree). Total score ranges from 36 to 180. A higher score indicates more parental stress (worse outcome).	Through study completion, an average of 12 months
Secondary	Goldberg Health Questionnaire (28 items) (GHQ-28)	This is a gold standard screening of adult psychopathology in 4 areas (anxiety, depression, somatic complaints, and social dysfunction). Each area is evaluated with 7 scores from 1 to 4. Subscales range from 7 to 28. A higher score indicates a higher level of problems (worse outcome).	Through study completion, an average of 12 months
Secondary	Dif?culties in Emotional Regulation Scale (DERS)	This is a gold standard to assess problems of Emotional Regulation (a key factor for mental health) using 36 items with 5 response options ranging from "1=almost never" to "5=almost always". Total score ranges 36-180. A higher score means higher emotional regulation dif?culty (worse outcome).	Through study completion, an average of 12 months
Secondary	Oxford Happiness Questionnaire (OHQ)	This is a gold standard to assess emotional well-being based on 8 items scored from "1=totally disagree" to "6=totally agree". The scale ranges from 8 to 48. A higher score indicates higher well-being (better outcome).	Through study completion, an average of 12 months
Secondary	Rosenberg's Self-Esteem Scale (RSES)	This is a gold standard to self-report adult self-esteem with 10 items scored from "1=totally agree" to "4=totally disagree". Total score ranges from 10 to 40. Once inverted, a higher score indicates higher self-esteem (better outcome).	Through study completion, an average of 12 months
Secondary	Parental Sense of Competence Scale (PSOC)	This scale consists of 10 items scored from 1 (totally disagree) to 6 (totally agree) to assess parental perceive self-competence. It ranges from 10 to 60. A higher score indicates a higher sense of self-competence in parenting (better outcome).	Through study completion, an average of 12 months
Secondary	Self-Other Mentalization Scale (SOMS)	This is a 10 items-based scale answered from 1 (very less than others) to 5 (much more than others). Self- and Other- subscales scores range from 5 to 25. Higher scores mean higher mentalization capacity (better outcome)	Through study completion, an average of 12 months
Secondary	Re?ective Functioning Scale - Youth (5 items version) (RFQ-Y5)	This is a shorter version of Fonagy's Re?ective Function Questionnaire. It includes 5 items scored from 1 (very disagree) to 5 (very agree) and ranges from 5 to 25, being a higher score indicative of higher mentalization capacity (better outcome).	Through study completion, an average of 12 months
Secondary	Trait Meta-Mood Scale - Children version (TMMS-C)	This instrument is here used as a measure of self-mentalizing. Only the 5 item-scale of 'clarity of emotions' will be used. Items score from 1=Not at all true, to 5=Completely true. Total score ranges from 5 to 25, being a higher score indicative of higher emotional clarity (better outcome).	Through study completion, an average of 12 months
Secondary	Big Five Questionnaire for Children and Adolescents (BFQ-NA)	This questionnaire assesses the big ?ve personality factors in young children using 65 items scored from 1=Almost always to 5=Almost never. In this study, the scale of kindness is used to score pro-social behavior, and the scale of emotional instability to score emotional dysregulation. A higher score indicates higher emotional instability (worse outcome) or higher pro-sociality (better outcome, after inverting the score).	Through study completion, an average of 12 months
Secondary	BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)	BarOn's scales of intra-personal (6 items) and inter-personal (12 items) scales, which are scored in 4-points scales ranging from '1=Never' to '4=Always'. The indicated subscales ranges are 4-24 and 12-48, respectively. A higher score indicates higher intelligence (better outcome).	Through study completion, an average of 12 months
Secondary	Rosenberg's Self-Esteem Scale - Child version (RSES-C)	This is a gold standard measure of self-esteem using 10 items which scored from "1=totally agree" to "4=totally disagree". After inverting the total score, which ranges from 10 to 40, a higher score means higher self-esteem (better outcome).	Through study completion, an average of 12 months
Secondary	Battery of Socialization (BAS)	The scales of social sensitivity, respect and self-control, and aggressivity, all scored using items ranging from Never (1) to Always (4), are here used to measure children's pro-social behavior. Higher scores mean higher pro-social dimensions (better outcome).	Through study completion, an average of 12 months

External Links

•   Heckman Curve
•   Mentalization and Mental Health Laboratory