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

NCT06270732 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-02-21

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

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, 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.

BEHAVIORAL

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 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.

Sponsors & Collaborators

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV
  • Universitat Autonoma de Barcelona

    lead OTHER

Principal Investigators

  • Sergi Ballespí, Researcher · Universitat Autònoma de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-02-21
Completion
2025-03-03

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270732 on ClinicalTrials.gov