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

NCT06270732 | Recruiting

• 1 other identifier: PID2021-125444OB-100-II-iM
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (8)

• Parental Reflective 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 reflective parenting (better outcome).

  Through study completion, an average of 12 months

• 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

• 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

• 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

• 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

• 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

• Strengths and Difficulties 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 (first 4 scales: worse outcome) or more pro-social behavior (last subscale: better outcome).

  Through study completion, an average of 12 months

• 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 Outcomes (14)

• Observing Mediational Interaction (OMI)

  Through study completion, an average of 12 months

• Parental Stress Questionnaire (PSI)

  Through study completion, an average of 12 months

• Goldberg Health Questionnaire (28 items) (GHQ-28)

  Through study completion, an average of 12 months

• Difficulties in Emotional Regulation Scale (DERS)

  Through study completion, an average of 12 months

• Oxford Happiness Questionnaire (OHQ)

  Through study completion, an average of 12 months

Other Outcomes (3)

• Inventory of Learning Patterns, reduced version (60 items) (ILP-60)

  Through study completion, an average of 12 months

• Relationship Questionnaire (RQ)

  Through study completion, an average of 12 months

• Time with the Child (TC)

  Through study completion, an average of 12 months

Study Arms (3)

Experimental: iMentalize Program (iMentalize)

EXPERIMENTAL

iMentalize is a structured new program specifically designed to foster mentalization in non-clinical general population. Inspired in Mentalization Based Treatments, which foster mentalization as a principal factor for salutogenesis in clinical settings, iMentalize aims to promote the parents' mentalization stance by using 30 structured sessions where parents are trained in MISC components (Mediational Intervention for Sensitizing Caregivers) to specifically help children to mentalize about cartoon's characters, about themselves, about the caregiver's mental states and about other close others. iMentalize is administered to parent-child dyads who work together in weekly 45-minutes sessions across 1 year.

Behavioral: iMentalize Program (iMentalize)

Mediational Intervention for Sensitizing Caregivers, Self-Administered (MISC-SA)

EXPERIMENTAL

This MISC version (MISC-SA) aims to transfer the MISC original training to wider communities by diminishing the cost of the teaching and learning. By implementing the MISC lessons in an online platform, thus allowing self-learning, the new Self- Administered version of MISC allows to obtain MISC training in 30 weekly sessions distributed across 12 months, in 2 blocks: 18 sessions from February to June, and 12 additional sessions from October to December. In contrast to the original version of MISC, this version allows the simultaneous self-training of a high number of participants with very low intervention of a supervisor, which diminishes the cost. MISC-SA keeps the core component of MISC training (video-feedback) by fostering participants to record interactions and then visualize them using guided reflection.

Behavioral: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)

Mediational Intervention for Sensitizing Caregivers - Readings (MISC-R): Treatment as Usual (TAU)

ACTIVE COMPARATOR

MISC-R is a more theoretical version of MISC training lacking the core MISC component (video-feedback). MISC-Readings provides the theoretical knowledge of MISC but lacking practice and reflection about MISC components by watching one's own video recorded interactions with the child. MISC-Readings substitutes all the time for practice and video-feedback with theoretical pills and readings, that is, with theoretical knowledge. Thus, this more theoretical MISC version can be assimilated to common intellectual trainings based on "cognitive" knowledge and pencil-and-paper exercises instead of skill-based training based on true practice for social-emotional skills development.

Behavioral: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)

Interventions

iMentalize Program (iMentalize) BEHAVIORAL

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.

Also known as: iMentalize

Experimental: iMentalize Program (iMentalize)

Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) BEHAVIORAL

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, reflection 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 reflection and video-feedback.

Also known as: MISC-SA

Mediational Intervention for Sensitizing Caregivers, Self-Administered (MISC-SA)

Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) BEHAVIORAL

This is an equivalent 30-hour online self-administered training involving 30 x 45' individual online sessions (22.5h), mostly based on reflection 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 reflective 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.

Also known as: MISC-R, TAU

Mediational Intervention for Sensitizing Caregivers - Readings (MISC-R): Treatment as Usual (TAU)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Universitat Autonoma de Barcelona: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (2)

Sergi Ballespí

Barcelona, 08193, Spain

RECRUITING

Universitat Autònoma de Barcelona

Barcelona, 08193, Spain

RECRUITING

Related Links

• Mentalization and Mental Health Laboratory
• Heckman Curve

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Sergi Ballespí, Researcher

  Universitat Autònoma de Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Ciraso, Researcher

CONTACT

++34661858272; anna.ciraso@uab.cat

Ana Carolina Pacheco, Researcher

CONTACT

+573153561564; anacarolina.pacheco@autonoma.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, parallel group, randomized controlled trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 5, 2024
• Primary Completion: February 21, 2025
• Study Completion: March 3, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)