Clinical trial NCT06101225: Effects of a Relaxation and Guided Imagery Intervention in School Context
Official title: RCT of the Effects of a Relaxation, Guided Imagery Intervention and Socioemotional Learning on the Psychophysiological Well-being, Socioemotional Regulation, Cognitive and Academic Development of Children in School
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Positive and Negative Affect
Social Skills
Happiness
Self Esteem
Self-Regulation, Emotion
Anxiety
Cognitive Change
Heart Rate Variability
Stress, Psychological
Physical Activity
Keywords: Guided Imagery
Relaxation
Well-being
Socioemotional Learning
Emotional Self-regulation
Psychophysiology
Randomized controled trial
Lead sponsor: Universidade Autónoma de Lisboa
Sponsor class: OTHER
Collaborators: name: Faculdade de Psicologia, Universidade de Lisboa
name: ISCTE-IUL
name: ISAMB - Faculdade de Medicina da Universidade de Lisboa
name: Technical University of Lisbon
name: Universidade Católica Portuguesa
name: Universidade Lusófona de Humanidades e Tecnologias
name: Universidade Nova de Lisboa
First posted: 2023-10-26
Enrollment: 240
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The RCT design includes 3 conditions to which classes (3rd and 4th graders) will be randomly allocated: the experimental group will receive MindRegulation intervention (a) relaxation and guided imagery with Socioemotional Leaning; the alternative condition group will receive relaxation intervention (b); and the waiting list control group will be involved in the regular school activities, with no intervention (c).

Interventions (a and b) will be held during 15 minutes in class, 3 school days per week, for 5 months. Data on all measures of the study will be collected at 4 data points: before the intervention (T0), during the intervention (TIntermediate); immediately after the intervention end (T1), and at follow-up (T2), 6 months after the intervention end, for the experimental (a) and alternative condition (b) groups. After follow-up, the waiting list control group will receive intervention (a), for 5 months, after which a post-intervention measurement will be performed.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Attend the 3rd and 4th grade of the selected school (8-11 years-old)

Exclusion Criteria:

* The participant classes have benefited from the RegularMind intervention previously;
* Not being able to provide self-report due to intellectual, physical or sensory disabilities.

Primary outcomes:
measure: Global Happiness Faces Scale
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Positive and Negative Affect (PANAS C)
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Mental Health Continuum (MHC)
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Socioemotional Skills - Socioemotional Skills Questionnaire (QACSE)
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Emotional Regulation Questionnaire - Children and Adolescents (ERQ-CA)
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Trait Anxiety Inventory for Children (STAI-C2)
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Lifespan-Self-esteem-scale - (LSE)
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Wechsler Intelligence Scale for Children (WISC-III) - Subtests: Maze, Symbol Search and Code subtests (for 8 to 11 years old).
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: D2 Test
timeFrame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)
measure: Heart Rate Variability (HRV) - Electrocardiogram
timeFrame: 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).
measure: Salivary Cortisol - Physiologic Stress
timeFrame: Change from baseline to post-test (at 6 months)
measure: Skin Conductance Level - Electrodermal Activity
timeFrame: 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).
measure: Actigraphy - Accelerometry
timeFrame: 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).
measure: Children's semi-structured self-reports
timeFrame: Immediately after the intervention.
measure: Children's Academic evaluation reports
timeFrame: Change from baseline to post-test (at 6 months); and to follow up (at 12 months).
measure: Strengths and Difficulties Questionnaire teacher's version (SDQ)
timeFrame: Change from baseline to post-test (at 6 months) and to follow up (at 12 months).
measure: Teachers semi-structured reports
timeFrame: Immediately after the intervention.
measure: Parent's semi-structured reports
timeFrame: Immediately after the intervention.
measure: Strengths and Difficulties Questionnaire parents version (SDQ)
timeFrame: Change from baseline to post-test (at 6 months); and change from baseline to follow up (at 12 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Universidade Autónoma de Lisboa
Study officials:
affiliation: Universidade Autónoma de Lisboa
name: Iolanda C. Galinha, Phd
role: PRINCIPAL_INVESTIGATOR
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