Emotional IntelligenceiMentalizeNCT06270732
Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population.
A study testing iMentalize Program (iMentalize), Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) and Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) in people with Emotional Intelligence and Social Interaction, run by Universitat Autonoma de Barcelona at 2 sites in Spain.
Trial summary
OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Intelligence, Social Interaction, Mental Health Wellness 1
- What is being tested?
- iMentalize Program (iMentalize), Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) and Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Feb 2024to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of a 6 to 18 years old child
- Written informed consent
- Understanding Catalan
- Pre-intervention assessment complete
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Sergi Ballespí
Barcelona, 08193
Anna Ciraso, Researcher, +34661858272, anna.ciraso@uab.cat
Ana Carolina Pacheco, Researcher, +573153561564, anacarolina.pacheco@autonoma.cat
- Recruiting
Universitat Autònoma de Barcelona
Barcelona, 08193
Anna Ciraso, Researcher, +34661858272, anna.ciraso@uab.cat
Ana Carolina Pacheco, Researcher, +573153561564, anacarolina.pacheco@autonoma.cat
About this study
Official title: Efficacy of iMentalize and Mediational Intervention for Sensitizing Caregivers - Self Administered Version (MISC-SA) to Foster Parents' Mentalization and Children Mental Health in Families From General Population (iMentalize Project).
OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.
PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.
Read more
COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:
- iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).
- iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).
- MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group).
Read the detailed description
CONTEXT: Mental health interventions are mostly provided once mental health is lost, that is, in context of psychopathology (i.e., when clinical levels of severity or impairment are reached). 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 with higher mentalization and interaction skills improves children's 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: 12-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 the non-clinical range of the mental ill-health continuum could benefit both the caregivers (parents) who receive the intervention and their children, who are daily exposed to them. Caregivers' benefits are expected in terms of improved mentalizing capacities (primary outcome) but also in terms of higher quality interactions, lower stress, lower distress symptoms, higher well-being and higher sense of self- efficacy (secondary outcomes). Child's mental health (primary outcome) is operationalized as 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 (secondary outcomes) are also expected because of the long-term exposition to adults enriched with new social-emotional skills based on the intervention. It is expected that parent's interventions could foster children mental health by promoting children mentalization skills (mediational or process variable).
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 105 participants (35 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
- Emotional Intelligence, Social Interaction, Mental Health Wellness 1, Well-Being, Psychological
- Being tested
- iMentalize Program (iMentalize), Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA), Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)
- Keywords
- Mentalization, Reflective function, Reflective parenting, Environmental enrichment, Parent-child interaction, Development, Mental Health, Emotional Health, Emotional well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMentalize Program (iMentalize)Behavioural
Also called iMentalize
This is a 30-hour group training involving 30 sessions lasting 45 minutes and 7.5 hours of inter-sessions work.
Session 1: Program presentation; Session 2: Reflective Parenting; Session 3: Cartoon's session I (baseline); Session 3: What is Mentalization; Session 4: Fundamentals of Human Interaction; Session 5: Cartoon's session II (the beginnings); Session 6: Mentalization and Mental Health; Session 7: MISC context and cultural components; Session 8: Cartoon's session III (practice with MISC context comp.); Session 9: The importance of emotions in human interaction; Session 10: MISC emotional components; Session 11: Cartoon's session IV (practice with emotional comp.); Session 11: How mentalization is developed; Session 12: MISC cognitive components; Session 13: Cartoon's session V (practice with cognitive comp.); Session 14: How to foster children mentalization skills. Sessions 15 to 30: Cartoon's sessions using MISC components to foster children mentalization.
Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)Behavioural
Also called MISC-SA
This is a 30-hour individual training involving 30-weekly online, individual, self-administered 45' sessions (22.5h) + 7.5h of between sessions work (readings, supervision, video- recordings for later video-feedback, reflection exercises). BLOCK I: Session 1: Presentation of the MISC program; Sessions 2 to 8 (Self-Administered or SA): Theoretical bases of the MISC; Sessions 9-18 (MISC practice and video-feedback); Summer break: Recording daily life interactions; BLOCK II: Session 19: Recap; Sessions 20-30: guided reflection and video-feedback.
Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)Behavioural
Also called MISC-R, TAU
This is an equivalent 30-hour online self-administered training involving 30 x 45' individual online sessions (22.5h), mostly based on reflection exercises around brief readings, pills, and animated shorts, but not video- feedback and guided practice. This is complemented with 7.5h of between-sessions work based on looking for new information, adult-child (non-guided) activities (and not for later video- feedback) or out-of-line guided reflective exercises.
Session 1: Program presentation; Session 2-8: Theoretical bases of MISC and mentalization; Session 9-16: MISC and mentalization applied to mental health; 17-18: Benefits of MISC to improve children learning; 19-20: Benefits of MISC for self-esteem; 21-22: The importance of MISC to foster mentalization; 23-24: Mentalization and pro-social behavior; 25-26: The importance of MISC to promote secure attachment; 27: MISC impact in epistemic trust; 28-29: MISC and well-being; 30: MISC, mentalization and environmental enrichment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: iMentalize Program (iMentalize) | Experimental | iMentalize is a structured new program specifically designed to foster mentalization in non-clinical general population. Inspired in Mentalization Based Treatments, which foster mentalization as a principal factor for salutogenesis in clinical settings, iMentalize aims to promote the parents' mentalization stance by using 30 structured sessions where parents are trained in MISC components (Mediational Intervention for Sensitizing Caregivers) to specifically help children to mentalize about cartoon's characters, about themselves, about the caregiver's mental states and about other close others. iMentalize is administered to parent-child dyads who work together in weekly 45-minutes sessions across 1 year. Receives: Behavioral: iMentalize Program (iMentalize) |
| Mediational Intervention for Sensitizing Caregivers, Self-Administered (MISC-SA) | Experimental | This MISC version (MISC-SA) aims to transfer the MISC original 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 30 weekly sessions distributed across 12 months, in 2 blocks: 18 sessions from February to June, and 12 additional sessions from October to December. In contrast to the original version of MISC, this version allows the simultaneous self-training of a high number of participants with very low intervention of a supervisor, which diminishes the cost. MISC-SA keeps the core component of MISC training (video-feedback) by fostering participants to record interactions and then visualize them using guided reflection. Receives: Behavioral: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) |
| Mediational Intervention for Sensitizing Caregivers - Readings (MISC-R): Treatment as Usual (TAU) | Active comparator | MISC-R is a more theoretical version of MISC training lacking the core MISC component (video-feedback). MISC-Readings provides the theoretical knowledge of MISC but lacking practice and reflection about MISC components by watching one's own video recorded interactions with the child. MISC-Readings substitutes all the time for practice and video-feedback with theoretical pills and readings, that is, with theoretical knowledge. Thus, this more theoretical MISC version can be assimilated to common intellectual trainings based on "cognitive" knowledge and pencil-and-paper exercises instead of skill-based training based on true practice for social-emotional skills development. Receives: Behavioral: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
Movie for the Assessment of Social Cognition (MASC)
The MASC consists of a 15-minute video stopping in 46 segments or items to assess adequate mentalizing, hyper-mentalizing, hypo-mentalizing or non-mentalizing. All scales range from 0 to 46. A higher score in adequate mentalizing indicates higher mentalizing capacity (better outcome). A higher score in the other 3 subscales indicates worse mentalizing capacity.
Measured: Through study completion, an average of 12 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).
Measured: Through study completion, an average of 12 months
Child Well-Being Level (CWBL)
This is 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).
Measured: Through study completion, an average of 12 months
Strengths and Difficulties Questionnaire (SDQ)
This is a 25 item-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).
Measured: Through study completion, an average of 12 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).
Measured: Through study completion, an average of 12 months
Secondary outcomes (14)
Observing Mediational Interaction (OMI)
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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)
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
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).
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start5 Feb 2024
- Primary completion21 Feb 2025 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional IntelligenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, parallel group, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Sergi Ballespí, Ph.D., Universitat Autonoma de Barcelona
- Investigators
- Sergi Ballespí, Researcher, Principal investigator, Universitat Autònoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270732
- Sponsor's protocol ID
- PID2021-125444OB-100-II-iM
- Acronym
- iMentalize
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The base of data will be shared through Universitat Autònoma de Barcelona (UAB) public repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of iMentalize and Mediational Intervention for Sensitizing Caregivers - Self Administered Version (MISC-SA) to Foster Parents' Mentalization and Children Mental Health in Families From General Population (iMentalize Project).
- ClinicalTrials.gov ID
- NCT06270732
- Acronym / sponsor ID
- iMentalize / PID2021-125444OB-100-II-iM
- Conditions
- Emotional Intelligence, Social Interaction, Mental Health Wellness 1, Well-Being, Psychological
- Keywords
- Mentalization, Reflective function, Reflective parenting, Environmental enrichment, Parent-child interaction, Development, Mental Health, Emotional Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 21 Feb 2025 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.
PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.
COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:
- iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).
- iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).
- MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group).
Detailed description
CONTEXT: Mental health interventions are mostly provided once mental health is lost, that is, in context of psychopathology (i.e., when clinical levels of severity or impairment are reached). 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 with higher mentalization and interaction skills improves children's 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: 12-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 the non-clinical range of the mental ill-health continuum could benefit both the caregivers (parents) who receive the intervention and their children, who are daily exposed to them. Caregivers' benefits are expected in terms of improved mentalizing capacities (primary outcome) but also in terms of higher quality interactions, lower stress, lower distress symptoms, higher well-being and higher sense of self- efficacy (secondary outcomes). Child's mental health (primary outcome) is operationalized as 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 (secondary outcomes) are also expected because of the long-term exposition to adults enriched with new social-emotional skills based on the intervention. It is expected that parent's interventions could foster children mental health by promoting children mentalization skills (mediational or process variable).
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 105 participants (35 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, parallel group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: iMentalize Program (iMentalize) | Experimental | Behavioral: iMentalize Program (iMentalize)iMentalize is a structured new program specifically designed to foster mentalization in non-clinical general population. Inspired in Mentalization Based Treatments, which foster mentalization as a principal factor for salutogenesis in clinical settings, iMentalize aims to promote the parents' mentalization stance by using 30 structured sessions where parents are trained in MISC components (Mediational Intervention for Sensitizing Caregivers) to specifically help children to mentalize about cartoon's characters, about themselves, about the caregiver's mental states and about other close others. iMentalize is administered to parent-child dyads who work together in weekly 45-minutes sessions across 1 year. |
| Mediational Intervention for Sensitizing Caregivers, Self-Administered (MISC-SA) | Experimental | Behavioral: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)This MISC version (MISC-SA) aims to transfer the MISC original 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 30 weekly sessions distributed across 12 months, in 2 blocks: 18 sessions from February to June, and 12 additional sessions from October to December. In contrast to the original version of MISC, this version allows the simultaneous self-training of a high number of participants with very low intervention of a supervisor, which diminishes the cost. MISC-SA keeps the core component of MISC training (video-feedback) by fostering participants to record interactions and then visualize them using guided reflection. |
| Mediational Intervention for Sensitizing Caregivers - Readings (MISC-R): Treatment as Usual (TAU) | Active comparator | Behavioral: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)MISC-R is a more theoretical version of MISC training lacking the core MISC component (video-feedback). MISC-Readings provides the theoretical knowledge of MISC but lacking practice and reflection about MISC components by watching one's own video recorded interactions with the child. MISC-Readings substitutes all the time for practice and video-feedback with theoretical pills and readings, that is, with theoretical knowledge. Thus, this more theoretical MISC version can be assimilated to common intellectual trainings based on "cognitive" knowledge and pencil-and-paper exercises instead of skill-based training based on true practice for social-emotional skills development. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parent of a 6 to 18 years old child
- Written informed consent
- Understanding Catalan
- Pre-intervention assessment complete
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iMentalize Program (iMentalize)Also: iMentalizeThis is a 30-hour group training involving 30 sessions lasting 45 minutes and 7.5 hours of inter-sessions work. Session 1: Program presentation; Session 2: Reflective Parenting; Session 3: Cartoon's session I (baseline); Session 3: What is Mentalization; Session 4: Fundamentals of Human Interaction; Session 5: Cartoon's session II (the beginnings); Session 6: Mentalization and Mental Health; Session 7: MISC context and cultural components; Session 8: Cartoon's session III (practice with MISC context comp.); Session 9: The importance of emotions in human interaction; Session 10: MISC emotional components; Session 11: Cartoon's session IV (practice with emotional comp.); Session 11: How mentalization is developed; Session 12: MISC cognitive components; Session 13: Cartoon's session V (practice with cognitive comp.); Session 14: How to foster children mentalization skills. Sessions 15 to 30: Cartoon's sessions using MISC components to foster children mentalization. | Behavioural | Experimental: iMentalize Program (iMentalize) |
| Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)Also: MISC-SAThis is a 30-hour individual training involving 30-weekly online, individual, self-administered 45' sessions (22.5h) + 7.5h of between sessions work (readings, supervision, video- recordings for later video-feedback, reflection exercises). BLOCK I: Session 1: Presentation of the MISC program; Sessions 2 to 8 (Self-Administered or SA): Theoretical bases of the MISC; Sessions 9-18 (MISC practice and video-feedback); Summer break: Recording daily life interactions; BLOCK II: Session 19: Recap; Sessions 20-30: guided reflection and video-feedback. | Behavioural | Mediational Intervention for Sensitizing Caregivers, Self-Administered (MISC-SA) |
| Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)Also: MISC-R, TAUThis is an equivalent 30-hour online self-administered training involving 30 x 45' individual online sessions (22.5h), mostly based on reflection exercises around brief readings, pills, and animated shorts, but not video- feedback and guided practice. This is complemented with 7.5h of between-sessions work based on looking for new information, adult-child (non-guided) activities (and not for later video- feedback) or out-of-line guided reflective exercises. Session 1: Program presentation; Session 2-8: Theoretical bases of MISC and mentalization; Session 9-16: MISC and mentalization applied to mental health; 17-18: Benefits of MISC to improve children learning; 19-20: Benefits of MISC for self-esteem; 21-22: The importance of MISC to foster mentalization; 23-24: Mentalization and pro-social behavior; 25-26: The importance of MISC to promote secure attachment; 27: MISC impact in epistemic trust; 28-29: MISC and well-being; 30: MISC, mentalization and environmental enrichment. | Behavioural | Mediational Intervention for Sensitizing Caregivers - Readings (MISC-R): Treatment as Usual (TAU) |
Primary outcome
Parental Reflective Function Questionnaire (PRFQ)
Time frame: Through study completion, an average of 12 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).
Trait Meta-Mood Scale (24 items) (TMMS-24)
Time frame: Through study completion, an average of 12 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).
Basic Empathy Scale (BES)
Time frame: Through study completion, an average of 12 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).
Movie for the Assessment of Social Cognition (MASC)
Time frame: Through study completion, an average of 12 months
The MASC consists of a 15-minute video stopping in 46 segments or items to assess adequate mentalizing, hyper-mentalizing, hypo-mentalizing or non-mentalizing. All scales range from 0 to 46. A higher score in adequate mentalizing indicates higher mentalizing capacity (better outcome). A higher score in the other 3 subscales indicates worse mentalizing capacity.
Stirling Children's Wellbeing Scale (SCWBS)
Time frame: Through study completion, an average of 12 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).
Child Well-Being Level (CWBL)
Time frame: Through study completion, an average of 12 months
This is 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)
Time frame: Through study completion, an average of 12 months
This is a 25 item-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).
Achenbach System for Empirically Assessment (ASEBA)
Time frame: Through study completion, an average of 12 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).
14 secondary outcomes
Observing Mediational Interaction (OMI)
Time frame: Through study completion, an average of 12 months
Parental Stress Questionnaire (PSI)
Time frame: Through study completion, an average of 12 months
Goldberg Health Questionnaire (28 items) (GHQ-28)
Time frame: Through study completion, an average of 12 months
Difficulties in Emotional Regulation Scale (DERS)
Time frame: Through study completion, an average of 12 months
Oxford Happiness Questionnaire (OHQ)
Time frame: Through study completion, an average of 12 months
Rosenberg's Self-Esteem Scale (RSES)
Time frame: Through study completion, an average of 12 months
Parental Sense of Competence Scale (PSOC)
Time frame: Through study completion, an average of 12 months
Self-Other Mentalization Scale (SOMS)
Time frame: Through study completion, an average of 12 months
Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5)
Time frame: Through study completion, an average of 12 months
Trait Meta-Mood Scale - Children version (TMMS-C)
Time frame: Through study completion, an average of 12 months
Big Five Questionnaire for Children and Adolescents (BFQ-NA)
Time frame: Through study completion, an average of 12 months
BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)
Time frame: Through study completion, an average of 12 months
Rosenberg's Self-Esteem Scale - Child version (RSES-C)
Time frame: Through study completion, an average of 12 months
Battery of Socialization (BAS)
Time frame: Through study completion, an average of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Mentalization and Mental Health LaboratoryLink provided by the sponsor.
- Heckman CurveLink provided by the sponsor.
- Individual participant dataSharing planned: No. The base of data will be shared through Universitat Autònoma de Barcelona (UAB) public repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergi Ballespí, Researcher principal investigator
Universitat Autònoma de Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iMentalize Program (iMentalize), Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) and Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) in people with Emotional Intelligence and Social Interaction, run by Universitat Autonoma de Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Ciraso, Researcher (++34661858272, anna.ciraso@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Reflective Function Questionnaire (PRFQ) (time frame: Through study completion, an average of 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.