An interventional study of MindRegulation Intervention and Relaxation in Mental Health Wellness 1, Positive and Negative Affect and Social Skills, sponsored by Universidade Autónoma de Lisboa. Recruiting at 1 site in Portugal. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Universidade Autónoma de Lisboa · Not applicable, Interventional, and Prevention
Specific aims - To test the effects of a relaxation and guided imagery intervention with socioemotional learning content on a range of socioemotional, physiological, cognitive and academic outcomes of school-aged children, measured through self-reports, neuropsychological and physiological measures, as well as teachers and parent's reports.
Background: Mental imagery has long been used in psychological therapies, but only recently has research started to provide a relevant scientific basis. Imagery interventions are inexpensive and have a body of research supporting their effectiveness on behavior change, the promotion of adaptive health outcomes, the reduction of anxiety and adherence to medical interventions in adults and children. However, literature on the relaxation and guided imagery interventions benefits for children in elementary school context is very scarce. This Randomized Controlled Trial (RCT) aims to contribute to the body of research by implementing and testing the benefits of an intervention program "MindRegulation" composed of relaxation, instructions for body posture, and guided imagery with socioemotional learning (SEL), conveying adaptive beliefs about oneself, the relationships with others and the environment.
Method: The MindRegulation intervention will be developed in the classroom for 15 minutes before learning activities, three times per week, for five months, and its effects will be measured on a range of emotional, physiologic, and cognitive outcomes. Twelve classes will be randomly distributed into three conditions: (a) relaxation and guided imagery, (b) just relaxation, and (c) waitlist control. The RCT includes four data collection times: pretest, intermediate, posttest, and a six-month follow-up. The sample comprises 240 students, third and fourth graders from elementary school, between 8 and 11 years old. The variables measured in the study are: well-being, affect, anxiety, emotional regulation, socioemotional competencies, attention and processing speed, physiologic responses of arousal, stress, and well-being, and perceived benefits of the intervention. The psychometric properties of the subjective measures show they are adequate for the study population and language, except for the self-esteem scale that will be validated to the study target population.
Discussion: Improvements on the children's well-being, socioemotional regulation, cognitive function, physiologic activity and academic performance are expected after five months of MindRegulation intervention and changes on physiologic activity are expected during each MindRegulation session. Mediation effects are expected for emotional regulation, well-being and anxiety variables, from participating in the intervention in the outcome variables such as socioemotional competence, cognitive function and academic performance. Additionally, well-being and anxiety levels at pretest are expected to moderate the intervention effects.
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
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Exclusion Criteria:
1. Relaxation exercises, breathing and closing the eyes, focusing on body parts; 2. The proposal of a guided imagery through narrated scripts, leading children through the visualization of beautiful scenarios and exposure to Social and Emotional Learning content - based on the Collaborative for Academic, Social, and Emotional Learning framework (CASEL), in three major themes: Me with myself (self-awareness and self-management); Me with the others (social-awareness and relationships skills); Me with the world (responsible decision making and social awareness); 3. Instructions for self-regulation of body posture and the use of touch (shoulders) to support children in posture regulation.
Other: MindRegulation Intervention
Relaxation exercises, breathing and closing the eyes, focusing on body parts.
Other: Relaxation
No intervention - regular school activities.
Other: Waiting List Control Group
The intervention is developed in class for 15 minutes before learning activities, three times per week, for five months - 57 sessions. Six different scripts with socioemotional learning content (based on CASEL framework) for each of the three themes will be applied.
Also known as: MindRegulation Intervention (condition a)
The relaxation condition will be developed in the same way as in RegularMente intervention, but without the guided imagery with SEL component. Relaxation exercises applied in class 15 minutes before learning activities, three times per week, for five months - in a total of 57 sessions.
Also known as: Relaxation (condition b)
No Intervention.
Also known as: Control Group (condition c)
Global Happiness Faces Scale
Faces Scale is a single-item measure of happiness that is reliable, valid and commonly used. This scale has only 1 item but it has seven simple drawings of faces that represent participants' response options to the question: "Overall, how do you feel?". Afterwards the participants must choose the face that best represents feelings ranging from "very unhappy" to "very happy".
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Positive and Negative Affect (PANAS C)
Positive and Negative Affect will be measured using a Portuguese short version of the PANAS-C. The original scale is composed of ten positive and ten negative emotions. Children rate how often they had felt each emotion under a specific time frame (e.g., over the past 2 weeks), using a 5-point scale (from 1 = very slightly or not at all to 5 = extremely). Higher scores on positive emotions and lower scores on negative emotions are indicative of higher of higher positive emotions.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Mental Health Continuum (MHC)
Mental health will be measured by the Mental Health Continuum Short Form (MHC-SF) Portuguese version. It measures positive mental health and is comprised by 14 items organized in three sub scales: emotional well-being (EWB) (3 items; e.g., "How often have you felt happy?"), social well-being (SWB) (5 items; e.g., "How often have you felt that you belong to a community such as a social group, your school, or your neighbourhood?), and psychological well-being (PWB) (6 items; e.g., "How often have you felt that you had warm and trusting relationships with others?"). This scale also provides a flourishing and languishing mental health indicator based on these three subscales: emotional well-being, social well-being, and psychological well-being. Respondents rate the frequency of each symptom of positive mental health in the past few months on a 6-point Likert type scale (0 = never to 5 = every day). Higher scores are indicative of higher Mental Health.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Socioemotional Skills - Socioemotional Skills Questionnaire (QACSE)
The Socioemotional Skills Questionnaire QACSE adaptation for children with 9 to 12 years old derives from de QACSE for adolescents (7th to 9th grade). This instrument consists of 39 items, answered on a four-point response scale from A "Never" to D ''Always", organized into six dimensions. Higher scores are indicative of higher levels on each dimension: Self-control; Social Awareness; Relational Skills; Social Isolation; Social Anxiety; Responsible Decision Making.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Emotional Regulation Questionnaire - Children and Adolescents (ERQ-CA)
Self-Regulation of Emotions will be measure with a Portuguese version of the emotional regulation questionnaire-children and adolescents (ERQ- CA) to assess emotional control strategies. The questionnaire comprises 10 items organized in two subscales: cognitive reappraisal (6 items; e.g., When I want to feel happier, I think about something different) and expressive suppression. Responses are given on a 5-point rating scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores are indicative of higher emotional regulation in children.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Trait Anxiety Inventory for Children (STAI-C2)
Anxiety will be measured with the Trait Anxiety Inventory for Children (STAI-C2), which measures a general proneness to anxious behavior rooted in the personality as a trait. The STAI-C2 comprises 20 items and asks the children how they generally feel, most of the days. It is a self-report inventory designed to be used with upper elementary or junior high school aged children. The answers range from 1 = almost never to 3 = often. In this study, Higher scores are indicative of higher levels of trait anxiety.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Lifespan-Self-esteem-scale - (LSE)
Self-Esteem will be measured by the Lifespan-Self-esteem-scale that is a global self-esteem scale for individuals of 5 to 89 years old. It has 4 items (e.g., "How do you feel about yourself") and the answers are registered on a 5 point scale from 1 = "really sad" to 5= "really happy". The response options are illustrated with faces expressing the appropriate feeling (e.g., really sad = crying face). Higher scores are indicative of higher self-esteem.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Wechsler Intelligence Scale for Children (WISC-III) - Subtests: Maze, Symbol Search and Code subtests (for 8 to 11 years old).
Cognitive function as attention, processing information speed, and working memory will be assessed through: (a) Maze, Symbol Search and Code subtests of the Wechsler Intelligence Scale for Children (WISC III). The Maze subtest analyzes the ability to anticipate and plan using visuospatial strategies in working memory, the Symbol Search subtest measures the ability of perceptual discrimination, dependent on visual attention capacity and working memory, and the Code subtest measures the ability to associate numbers with symbols, and memorizing the associations in order to complete the task as quickly as possible. Higher scores on these subscales are indicative of higher cognitive function on attention and speed processing.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
D2 Test
Selective and sustained attention, information processing speed, precision, and qualitative aspects related with the performance will be measured with the D2 test. It can be administered to children from 8 years of age. Its administration lasts about 8-10 minutes. It is considered a cancellation or dam test, where the individual registers a (/) on the letters "d", from left to right, while ignoring the other stimuli, on each of the 14 lines and having 20 seconds per line. Higher scores on this test is indicative of higher cognitive function, namely attention and speed processing.
Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
Heart Rate Variability (HRV) - Electrocardiogram
Heart Rate Variability (HRV) is a physiological measure of emotional regulation and well-being and it varies as a result of relaxation interventions. HRV will be calculated from continuous HR acquisition, resorting to portable and comfortable sports arm band (BItalino by Plux), with two electrocardiogram sensors attached to the upper chest with electrodes. Register will be made in two consecutive days, in the morning, during 40 minutes.
Time frame: Change from baseline to Intermediate (at 3 months); Change from baseline to post-test (at 6 months); and change from baseline to follow up (at 12 months).
Salivary Cortisol - Physiologic Stress
Salivary Cortisol - Physiologic Stress will be assessed through diurnal salivary cortisol slope, using salivettes, a reliable noninvasive method, in a subsample of 100 children. It will be collected in two days. On day one, four samples will be collected at 9.15/30h, 12.15/30h, 14.15/30h, and bedtime, with no food ingestion, washing teeth or vigorous physical activity, half an hour before assessment). On day 2, three samples will be collected at 9.15/30h, 12.15/30h and bedtime.
Time frame: Change from baseline to post-test (at 6 months)
Skin Conductance Level - Electrodermal Activity
Emotional activation (arousal) - Skin Conductance Level, is a measure of fluctuations in the activity of the sympathetic nervous system, and in the emotional state. It will be measured with BItalino by Plux in a comfortable arm band, with two sensors attached with two velcro rings to two fingers of the non dominant hand. Register will be made in two consecutive days, in the morning, during 40 minutes.
Time frame: Change from baseline to intermediate (at 3 months); change from baseline to post-test (at 6 months); and change from baseline to follow up (at 12 months).
Actigraphy - Accelerometry
Physical activity will be measured with an accelerometer (BItalino by Plux) in a comfortable arm band, placed in the non dominant arm, above the elbow. Measurements will be made in two consecutive mornings, during 40 minutes.
Time frame: Change from baseline to intermediate (at 3 months); change from baseline to post-test (at 6 months); and change from baseline to follow up (at 12 months).
Children's semi-structured self-reports
After the last intervention session, a session will be held to collect qualitative data on the child's perception of the benefits of the intervention.
Time frame: Immediately after the intervention.
Children's Academic evaluation reports
Children's Academic achievement - the complete report on each students' academic performance by the teachers, including grades, behavior and absenteeism to classes, from the 1st, 2nd and 3rd periods.
Time frame: Change from baseline to post-test (at 6 months); and to follow up (at 12 months).
Strengths and Difficulties Questionnaire teacher's version (SDQ)
Socioemotional skills of children will be measured by the Strengths and Difficulties Questionnaire teachers version (Portuguese version). The SDQ teachers' version consists of twenty-five items, organized into five scales containing 5 items and each item has three response options on a scale (not true, rated 0 or 2; hardly true, rated 1; very true, rated 2 or 0). It has 5 subscales: emotional symptoms, behavior problems, hyperactivity, relationship problems with colleagues, and prosocial behavior. Lower scores are indicative of higher socioemotional skills of children.
Time frame: Change from baseline to post-test (at 6 months) and to follow up (at 12 months).
Teachers semi-structured reports
Teachers will be asked to reply to two semi-structured questions about their perception of the benefits of the intervention for the childrens' well-being, socioemotional and cognitive development and in what way did it contribute to the class functioning and their work with children.
Time frame: Immediately after the intervention.
Parent's semi-structured reports
Parents will be asked to reply to one semi-structured question about their perception of the benefits of the intervention for their childrens' well-being, behavior, and development.
Time frame: Immediately after the intervention.
Strengths and Difficulties Questionnaire parents version (SDQ)
Socioemotional skills of children will be measured by the Strengths and Difficulties Questionnaire parents version (Portuguese version). Socioemotional skills of children will be measured by the Strengths and Difficulties Questionnaire teachers version (Portuguese version). The SDQ parent's version consists of twenty-five items, organized into five scales containing 5 items and each item has three response options on a scale (not true, rated 0 or 2; hardly true, rated 1; very true, rated 2 or 0). It has 5 subscales: emotional symptoms, behavior problems, hyperactivity, relationship problems with colleagues, and prosocial behavior. Lower scores are indicative of higher socioemotional skills of children.
Time frame: Change from baseline to post-test (at 6 months); and change from baseline to follow up (at 12 months).
Plan to share: No
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