Efficacy of the Mediational Intervention for Sensitizing Caregivers for Teachers and Self-Administered Versions
- Conditions
- Randomized Controlled Trial
- Interventions
- Behavioral: Mediational Intervention for Sensitizing Caregivers, Teachers' version (MISC-T)Behavioral: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)
- Registration Number
- NCT06150313
- Lead Sponsor
- Universitat Autonoma de Barcelona
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediational Intervention for Sensitizing Caregivers, Teachers' version (MISC-T) Mediational Intervention for Sensitizing Caregivers, Teachers' version (MISC-T) MISC-T is an adaptation of MISC for trainers. The trainer is the figure who trains a caregiver to enable him/her to interact with higher quality (i.e., with more MISC components). MISC for trainers is commonly administered to groups of 6-20 trainees, either face to face or using videoconference, and consists of 8 hours of theory about MISC principles and 12 hours of practice using video feedback. Video feedback is the core component of MISC training, which aims to transfer more competency than knowledge, using ecological practice. This means using video recordings of daily interactions with a significant child and watching them together (supervisor and trainee) to enable the trainee to realize the consequences of MISC components. MISC for trainers was adapted to be administered to groups of 6-12 teachers using 4 x 2-hours theoretical sessions (8h) and 11 x 1.5-hours of practice using video-feedback. Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) This MISC version (MISC-SA) aims to transference the MISC 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 25 weekly sessions distributed across 7 months (approximately, a scholar course). In contrast to MISC-T, this version allows the simultaneous self-training of a high number of participants with very low intervention of a supervisor, which diminishes the cost. As MISC-T, MISC-SA keeps the core component of MISC trainings (video-feedback) by fostering participants to record interactions and then visualize them using guided reflection.
- Primary Outcome Measures
Name Time Method OMI (Observing Mediational Interaction) Through study completion, an average of 17 months This is the observational measure used in the Mediational Intervention for Sensitizing Caregivers (MISC) and quantifies 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).
Child Well-Being Level (CWBL) Through study completion, an average of 17 months This is a 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).
Strengths and Difficulties Questionnaire (SDQ) Through study completion, an average of 17 months This is a 25 items-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).
Stirling Children's Wellbeing Scale (SCWBS) Through study completion, an average of 17 months 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).
Achenbach System for Empirically Assessment (ASEBA) Through study completion, an average of 17 months 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).
- Secondary Outcome Measures
Name Time Method Big Five Questionnaire for Children and Adolescents (BFQ-NA) Through study completion, an average of 17 months This questionnaire assesses the big five 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).
Teachers' Reflective Function Questionnaire (TRFQ) Through study completion, an average of 17 months This is an adaptation of the Parental Reflecting Function Questionnaire which allows to assess the mentalization stance of teachers toward their students by using 19 items scored from 1 (Completely disagree) to 7 (Completely agree). Total score ranges from 19 to 133. A higher score indicates more teachers' mentalization stance (better outcome).
Self-Other Mentalization Scale (SOMS) Through study completion, an average of 17 months 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)
Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5) Through study completion, an average of 17 months This is a shorter version of Fonagy's Reflective 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).
Trait Meta-Mood Scale - Children version (TMMS-C) Through study completion, an average of 17 months 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).
BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn) Through study completion, an average of 17 months 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).
Battery of Socialization (BAS) Through study completion, an average of 17 months 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).
Goldberg Health Questionnaire (28 items) (GHQ-28) Through study completion, an average of 17 months 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).
Trait Meta-Mood Scale (24 items) TMMS-24 Through study completion, an average of 17 months 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).
Parental Reflective Function Questionnaire (PRFQ) Through study completion, an average of 17 months 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).
Basic Empathy Scale (BES) Through study completion, an average of 17 months 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).
Maslach Burnout Inventory (MBI) Through study completion, an average of 17 months This is a gold standard to assess stress at work and burnout, based on 22 items scored from 0 (Never) to 6 (Every day). Total score ranges from 22 to 132. A higher score is indicative of more stress at work or burn out (worse outcome).
Rosenberg's Self-Esteem Scale - Child version (RSES-C) Through study completion, an average of 17 months 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).
Difficulties in Emotional Regulation Scale (DERS) Through study completion, an average of 17 months 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 difficulty (worse outcome).
Rosenberg's Self-Esteem Scale (RSES) Through study completion, an average of 17 months 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).
Oxford Happiness Questionnaire (OHQ) Through study completion, an average of 17 months 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).
Parental Stress Questionnaire (PSI) Through study completion, an average of 17 months 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).
Parental Sense of Competence Scale (PSOC) Through study completion, an average of 17 months 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).
Trial Locations
- Locations (1)
Sergi Ballespí
🇪🇸Barcelona, Spain/Catalonia, Spain