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).
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emotional Intelligence
- Sponsor
- Universitat Autonoma de Barcelona
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Basic Empathy Scale (BES)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
Investigators
Sergi Ballespí, Ph.D.
Principal Investigator
Universitat Autonoma de Barcelona
Eligibility Criteria
Inclusion Criteria
- •Parent of a 6 to 18 years old child
- •Written informed consent
- •Understanding Catalan
- •Pre-intervention assessment complete
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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).
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).
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).
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).
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).
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).
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).
Secondary Outcomes
- BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)(Through study completion, an average of 12 months)
- Rosenberg's Self-Esteem Scale - Child version (RSES-C)(Through study completion, an average of 12 months)
- Observing Mediational Interaction (OMI)(Through study completion, an average of 12 months)
- Goldberg Health Questionnaire (28 items) (GHQ-28)(Through study completion, an average of 12 months)
- Parental Sense of Competence Scale (PSOC)(Through study completion, an average of 12 months)
- Big Five Questionnaire for Children and Adolescents (BFQ-NA)(Through study completion, an average of 12 months)
- Parental Stress Questionnaire (PSI)(Through study completion, an average of 12 months)
- Oxford Happiness Questionnaire (OHQ)(Through study completion, an average of 12 months)
- Trait Meta-Mood Scale - Children version (TMMS-C)(Through study completion, an average of 12 months)
- Battery of Socialization (BAS)(Through study completion, an average of 12 months)
- Difficulties in Emotional Regulation Scale (DERS)(Through study completion, an average of 12 months)
- Rosenberg's Self-Esteem Scale (RSES)(Through study completion, an average of 12 months)
- Self-Other Mentalization Scale (SOMS)(Through study completion, an average of 12 months)
- Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5)(Through study completion, an average of 12 months)