Mental Health Wellness 1 Clinical Trial
— iMentalizeOfficial 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. 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).
Status | Recruiting |
Enrollment | 105 |
Est. completion date | March 3, 2025 |
Est. primary completion date | February 21, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: - Parent of a 6 to 18 years old child - Written informed consent - Understanding Catalan - Pre-intervention assessment complete Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Spain | Sergi Ballespí | Barcelona | |
Spain | Universitat Autònoma de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Autonoma de Barcelona | Ministerio de Economía y Competitividad, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inventory of Learning Patterns, reduced version (60 items) (ILP-60) | This instrument measures learning patterns, which are considered to moderate the impact of the intervention. It consists of 60 items evaluating 4 learning components (processing strategies, regulation strategies, conceptions of learning, learning orientations) with 15 x 5-point Lickert scale items each. All scales range from 15 to 75. A higher score means a higher presence of that component or a higher tendency to use that pattern (potential moderator). | Through study completion, an average of 12 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 identi?es 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 a higher presence of that relationship style (potential moderator). | Through study completion, an average of 12 months | |
Other | Time with the Child (TC) | This is an ad hoc scale to calculate the amount of real time of interaction (communication and reciprocal influence) with the child in daily minutes, across 1 week (from Monday to Sunday). It ranges from 0 to several hours. A higher score means more time for real interaction with the child (in minutes) per day or per week. This is used as a measure of exposure to the "enriched" parenting (potential moderator). | Through study completion, an average of 12 months | |
Primary | Parental Re?ective 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 re?ective parenting (better outcome). | Through study completion, an average of 12 months | |
Primary | 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 12 months | |
Primary | 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 12 months | |
Primary | 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. | Through study completion, an average of 12 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 12 months | |
Primary | 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). | Through study completion, an average of 12 months | |
Primary | Strengths and Dif?culties 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 (?rst 4 scales: worse outcome) or more pro-social behavior (last subscale: better outcome). | Through study completion, an average of 12 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 12 months | |
Secondary | Observing Mediational Interaction (OMI) | This is the observational measure used in the Mediational Intervention for Sensitizing Caregivers (MISC) and quanti?es 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 12 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 12 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 12 months | |
Secondary | Dif?culties 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 dif?culty (worse outcome). | Through study completion, an average of 12 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 12 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 12 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 12 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 12 months | |
Secondary | Re?ective Functioning Scale - Youth (5 items version) (RFQ-Y5) | This is a shorter version of Fonagy's Re?ective 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 12 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 12 months | |
Secondary | Big Five Questionnaire for Children and Adolescents (BFQ-NA) | This questionnaire assesses the big ?ve 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 12 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 12 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 12 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 12 months |
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