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

NCT06150313 | Unknown DMC

• 1 other identifier: PID2021-125444OB-100
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (18)

• Self-Other Mentalization Scale (SOMS)

  Through study completion, an average of 17 months

• Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5)

  Through study completion, an average of 17 months

• Trait Meta-Mood Scale - Children version (TMMS-C)

  Through study completion, an average of 17 months

• Big Five Questionnaire for Children and Adolescents (BFQ-NA)

  Through study completion, an average of 17 months

• BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)

  Through study completion, an average of 17 months

Other Outcomes (2)

• Vermunt's Learning Regulation Scale (VLRS-28)

  Through study completion, an average of 17 months

• Relationship Questionnaire (RQ)

  Through study completion, an average of 17 months

Study Arms (3)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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

Also known as: MISC for Trainers adapted for groups of Teachers, MISC-T

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

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

Also known as: MISC-SA

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

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

Also known as: MISC-R, TAU

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

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Autonoma de Barcelona: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Sergi Ballespí

Barcelona, Spain/Catalonia, 08193, Spain

RECRUITING

Study Officials

• Sergi Ballespí, PI

  Universitat Autònoma de Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Carolina Pacheco, Researcher

CONTACT

+34935814286; Anacarolina.pacheco@autonoma.cat

Lucía Murillo, Researcher

CONTACT

+34935814286; lucia.murillo@autonoma.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind, parallel group, randomized controlled trial

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: November 29, 2023
• Study Start: September 12, 2023
• Primary Completion: January 15, 2025
• Study Completion: February 2, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)