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

NCT ID: NCT06150313

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2025-02-02

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.

Conditions

Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mediational Intervention for Sensitizing Caregivers, Teachers' version (MISC-T)

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R)

Teachers usually do not get training to improve the quality of the interactions. However, to avoid using a Waiting-List or a Placebo control group, a last version of MISC training was designed but, this time, without the core MISC component: video-feedback. MISC-Readings provides the theoretical knowledge of MISC but lacks practice and reflection of MISC components by watching once own video recorded interactions with a significant child. MISC-Readings substitutes all the practice time of the other versions (video-feedback) by readings, that is, theoretical knowledge. This assimilates this version to the 'intellectual' or more theoretical format of teachers' common training, even when it is referred to social-emotional learning.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

MISC for Trainers adapted for groups of Teachers; MISC-T; MISC-SA; MISC-R; TAU

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

Universitat Autonoma de Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Sergi Ballespí, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergi Ballespí, PI

Role: PRINCIPAL_INVESTIGATOR

Universitat Autònoma de Barcelona

Locations

Sergi Ballespí

Barcelona, Spain/Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ana Carolina Pacheco, Researcher

Role: CONTACT

Phone: +34935814286

Email: Anacarolina.pacheco@autonoma.cat

Lucía Murillo, Researcher

Role: CONTACT

Phone: +34935814286

Email: lucia.murillo@autonoma.cat

Facility Contacts

Sergi Ballespí, PI

Role: primary

Ana Pacheco, Investigator

Role: backup

Other Identifiers

PID2021-125444OB-100

Identifier Type: -

Identifier Source: org_study_id