Clinical trial NCT06150313: Efficacy of the Mediational Intervention for Sensitizing Caregivers for Teachers and Self-Administered Versions
Official title: Efficacy of the Mediational Intervention for Sensitizing Caregivers - Teachers' Version (MISC-T) and Self-Administered Version (MISC-SA) to Improve the Quality of Caregivers' Interactions and Children Mental Health (MISC-SA/T Project)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Randomized Controlled Trial
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2023-11-29
Enrollment: 105
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-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 2 new modalities of the Mediational Intervention for Sensitizing Caregivers (MISC) in caregivers from general population, specifically, in teachers at primary school children who are also parents.

The main QUESTIONS it aims to answer are:

* Are the new versions of MISC (MISC-T for Teachers, and MISC-SA or Self-Administered) efficient to a) improve the quality of caregivers-child interaction, and b) benefit children mental health, compared with a control group defined as Treatment as Usual (TAU)?
* Is there any effect-transference to the school-setting despite the MISC is trained out of the school setting? re the new versions of the MISC efficient to benefit teachers' well-being at work in terms of lower burn-out, higher perceived self-efficacy or better classroom climate?

PARTICIPANTS will randomly receive one of the 3 versions of MISC: MISC-T (administered by videoconference in teams of 6-10 teachers), MISC-SA (self-administered by the participants in weekly sessions with Genially), and MISC-R (self-administered by the participants but mainly based in readings and cognitive exercises instead of video-feedback, the core element of MISC-T and MISC-SA).

COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:

* MISC-T shows efficacy compared with MISC-R (TAU; control group)
* MISC-SA shows efficacy compared with MISC-R (TAU; control group)
* MISC-T is more efficient than MISC-SA

Detailed description: CONTEXT: Mental health interventions are mostly provided once mental health is lost, that is, in context of psychopathology (clinical impairment). 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 and teachers social-emotional skills (two of the main figures in child rearing) improves children 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: 17-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 non-clinical points of the mental ill-health continuum could benefit both the caregivers who receive the intervention (who are parents and teachers as well) and the children who daily exposed to them (their own children and their school students). Caregivers' benefits are expected in terms of improved mentalizing capacities, lower stress, higher well-being and higher sense of self-efficacy both at home (parenting) and at work (school). Child's mental health is operationalized s 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 are also expected because of the long-term exposition to adults enriched with new social-emotional skills thanks to the intervention.

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 150 participants (50 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:

Teachers of school- or preschool-age children, currently teaching, who are parents (either of a school-age child (6-12 years old) or an adolescent (12-18)), or who can record interactions with a similar age close child (e.g., nephew). The "parent" condition is important because a) it allows participants to do this training with a very close child (son/daughter) with who it is easy to record daily-life interactions to then train using video-feedback, a key element in MISC (Mediational Intervention for Sensitizing Caregivers); b) because it allows a uniform measurement of the impact of parental MISC intervention in the mental health of the children currently (daily) exposed to those parents (their sons/daughters). The "teacher" condition allows to examine to what extent MISC training effects might be transferred beyond the own child (with whom the training is done: son / daughter) and can be extended to other contexts like the school setting.

1. Teachers at school- (6-12) or preschool (3-6) in active
2. Parents who have a son or daughter 6-18 years old
3. Possibilities to receive at least 1 of the 3 interventions
4. Understanding Catalan
5. Written informed content

Exclusion criteria:

1. Teachers who are not currently teaching in school or preschool degrees
2. Impossibility to record interaction with a significant child
3. Inability to attend the intervention randomly assigned

Primary outcomes:
measure: OMI (Observing Mediational Interaction)
timeFrame: Through study completion, an average of 17 months
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Through study completion, an average of 17 months
measure: Achenbach System for Empirically Assessment (ASEBA)
timeFrame: Through study completion, an average of 17 months
measure: Stirling Children's Wellbeing Scale (SCWBS)
timeFrame: Through study completion, an average of 17 months
measure: Child Well-Being Level (CWBL)
timeFrame: Through study completion, an average of 17 months
Secondary outcomes:
measure: Self-Other Mentalization Scale (SOMS)
timeFrame: Through study completion, an average of 17 months
measure: Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5)
timeFrame: Through study completion, an average of 17 months
measure: Trait Meta-Mood Scale - Children version (TMMS-C)
timeFrame: Through study completion, an average of 17 months
measure: Big Five Questionnaire for Children and Adolescents (BFQ-NA)
timeFrame: Through study completion, an average of 17 months
measure: BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)
timeFrame: Through study completion, an average of 17 months
measure: Rosenberg's Self-Esteem Scale - Child version (RSES-C)
timeFrame: Through study completion, an average of 17 months
measure: Battery of Socialization (BAS)
timeFrame: Through study completion, an average of 17 months
measure: Goldberg Health Questionnaire (28 items) (GHQ-28)
timeFrame: Through study completion, an average of 17 months
measure: Difficulties in Emotional Regulation Scale (DERS)
timeFrame: Through study completion, an average of 17 months
measure: Trait Meta-Mood Scale (24 items) TMMS-24
timeFrame: Through study completion, an average of 17 months
measure: Rosenberg's Self-Esteem Scale (RSES)
timeFrame: Through study completion, an average of 17 months
measure: Oxford Happiness Questionnaire (OHQ)
timeFrame: Through study completion, an average of 17 months
measure: Parental Reflective Function Questionnaire (PRFQ)
timeFrame: Through study completion, an average of 17 months
measure: Parental Sense of Competence Scale (PSOC)
timeFrame: Through study completion, an average of 17 months
measure: Parental Stress Questionnaire (PSI)
timeFrame: Through study completion, an average of 17 months
measure: Basic Empathy Scale (BES)
timeFrame: Through study completion, an average of 17 months
measure: Maslach Burnout Inventory (MBI)
timeFrame: Through study completion, an average of 17 months
measure: Teachers' Reflective Function Questionnaire (TRFQ)
timeFrame: Through study completion, an average of 17 months
Other outcomes:
measure: Vermunt's Learning Regulation Scale (VLRS-28)
timeFrame: Through study completion, an average of 17 months
measure: Relationship Questionnaire (RQ)
timeFrame: Through study completion, an average of 17 months
Locations:
city: Barcelona
country: Spain
facility: Sergi Ballespí
state: Spain/Catalonia
Study officials:
affiliation: Universitat Autònoma de Barcelona
name: Sergi Ballespí, PI
role: PRINCIPAL_INVESTIGATOR
References: