Efficacy of the Mediational Intervention for Sensitizing Caregivers for Teachers and Self-Administered Versions

Randomized Controlled Trial Clinical Trial

— MISC-SA/T  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150313
• Other study ID #: PID2021-125444OB-100
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: February 2, 2025

Study information

• Verified date: November 2023
• Source: Universitat Autonoma de Barcelona
• Contact: Ana Carolina Pacheco, Researcher
• Phone: +34935814286
• Email: Anacarolina.pacheco[@]autonoma.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 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: February 2, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Randomized Controlled Trial

Intervention

Behavioral:
• Mediational Intervention for Sensitizing Caregivers, Teachers' version (MISC-T)
This is a 36-hour group training involving 4 theoretical + 11 practice online sessions using video-feedback, the core component of MISC original trainings. Session 1: MISC presentation; Session 2: Bases of the interaction and MISC culture-context components; Session 3: The emotions in the interaction and MISC emotional components; Session 4: MISC cognitive components and implications for learning; Session 5: Practice with you-tube examples of interaction; Session 6: Practice with trainer's examples of video-feedback. Sessions 7 to 14: Practice with participants' video-recordings. Session 15: End of the intervention, last video-feedback training and preparing for post-assessment.
• Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)
This is a 36-hour individual training involving 25-weekly online, individual, self-administered 50' sessions (21h) + 4 online 1.5-hour group meetings with a supervisor (6h) and 9h of between sessions work (readings, video-recordings for later video-feedback, reflection exercises). Session 1 (Supervisor): Presentation of the MISC program; Sessions 2 to 8 (Self-Administered or SA): Theoretical bases of the MISC: Session 9 (Supervisor): Summary, online group exercises and keys for forward recordings; Sessions 10-11 (Christmas Homework): Recording daily life interactions; Sessions 12-17 (SA): guided reflection with video-feedback; Session 18 (Supervisor): Control session for doubts and video-feedback group training. Sessions 19-28 (SA): guided reflection with video-feedback. Session 29 (Supervisor): Final online video-feedback group training.

Other:
• Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)
This is an equivalent 36-hour online self-administered training involving 27 x 45' individual online sessions (20.25h), mostly based on reflection exercises around brief readings, animated shorts, or pills, but not video-feedback. This is complemented with 2 x 1.5h online group face-to-face sessions with a supervisor (3h) and 13h of between-sessions work based on looking for new information, adult-child activities (but not for video-feedback) or out-of-line guided reflective exercises. Session 1 (Supervisor): group meeting for program presentation; Sessions 2-28 (Self-Administered): Online self-administered sessions doing readings or watching pills; Session 29 (Supervisor): Final doubts session to close de course.

Locations

Country	Name	City	State
Spain	Sergi Ballespí	Barcelona	Spain/Catalonia

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	Vermunt's Learning Regulation Scale (VLRS-28)	This instrument measures learning patterns, which are considered to moderate the impact of the intervention. It consists of 28 items assessing the 4 learning patterns of Vemunt's model with 4 x 7-item scales scored from 1 (Never) to 5 (Always). All 4 subscales range from 7 to 28. A higher score means a higher presence (or tendency to use) that pattern (potential moderator).	Through study completion, an average of 17 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 identifies 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 higher presence of that relationship style (potential moderator).	Through study completion, an average of 17 months
Primary	OMI (Observing Mediational Interaction)	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).	Through study completion, an average of 17 months
Primary	Strengths and Difficulties Questionnaire (SDQ)	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).	Through study completion, an average of 17 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 17 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 17 months
Primary	Child Well-Being Level (CWBL)	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).	Through study completion, an average of 17 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 17 months
Secondary	Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5)	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).	Through study completion, an average of 17 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 17 months
Secondary	Big Five Questionnaire for Children and Adolescents (BFQ-NA)	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).	Through study completion, an average of 17 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 17 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 17 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 17 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 17 months
Secondary	Difficulties 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 difficulty (worse outcome).	Through study completion, an average of 17 months
Secondary	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 17 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 17 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 17 months
Secondary	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 17 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 17 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 17 months
Secondary	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 17 months
Secondary	Maslach Burnout Inventory (MBI)	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).	Through study completion, an average of 17 months
Secondary	Teachers' Reflective Function Questionnaire (TRFQ)	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).	Through study completion, an average of 17 months