Effects of a Relaxation and Guided Imagery Intervention in School Context

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT06101225

Acronym / sponsor ID

MR / MindRegulation BIAL212/22

Conditions

Mental Health Wellness 1, Positive and Negative Affect, Social Skills, Happiness, Self Esteem, Self-Regulation, Emotion

Keywords

Guided Imagery, Relaxation, Well-being, Socioemotional Learning, Emotional Self-regulation, Psychophysiology, Randomized controled trial

Study type

Interventional

Recruitment status

Unknown status

Enrolment

240 participants (estimated)

Lead sponsor

Universidade Autónoma de LisboaUniversity, hospital or other

Collaborators

Faculdade de Psicologia, Universidade de Lisboa, ISCTE-IUL, ISAMB - Faculdade de Medicina da Universidade de Lisboa, Technical University of Lisbon, Universidade Católica Portuguesa, Universidade Lusófona de Humanidades e Tecnologias, Universidade Nova de Lisboa

Study start

9 Oct 2023 (actual)

Primary completion

30 Jul 2025 (estimated)

Study completion

30 Jun 2026 (estimated)

First posted

26 Oct 2023 (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.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (investigator, outcomes assessor)

Number of arms

3

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.

Who may qualify

Ages

7 to 12 years

Sex

All

Healthy volunteers

Accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Global Happiness Faces Scale

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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".

2. Positive and Negative Affect (PANAS C)

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

3. Mental Health Continuum (MHC)

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

4. Socioemotional Skills - Socioemotional Skills Questionnaire (QACSE)

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

5. Emotional Regulation Questionnaire - Children and Adolescents (ERQ-CA)

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

6. Trait Anxiety Inventory for Children (STAI-C2)

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

7. Lifespan-Self-esteem-scale - (LSE)

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

8. Wechsler Intelligence Scale for Children (WISC-III) - Subtests: Maze, Symbol Search and Code subtests (for 8 to 11 years old).

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

9. D2 Test

   Time frame: Change from baseline to post-test (at 6 months) and to follow-up (at 12 months)

   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.

10. Heart Rate Variability (HRV) - Electrocardiogram

    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).

    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.

11. Salivary Cortisol - Physiologic Stress

    Time frame: Change from baseline to post-test (at 6 months)

    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.

12. Skin Conductance Level - Electrodermal Activity

    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).

    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.

13. Actigraphy - Accelerometry

    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).

    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.

14. Children's semi-structured self-reports

    Time frame: Immediately after the intervention.

    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.

15. Children's Academic evaluation reports

    Time frame: Change from baseline to post-test (at 6 months); and to follow up (at 12 months).

    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.

16. Strengths and Difficulties Questionnaire teacher's version (SDQ)

    Time frame: Change from baseline to post-test (at 6 months) and to follow up (at 12 months).

    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.

17. Teachers semi-structured reports

    Time frame: Immediately after the intervention.

    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.

18. Parent's semi-structured reports

    Time frame: Immediately after the intervention.

    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.

19. Strengths and Difficulties Questionnaire parents version (SDQ)

    Time frame: Change from baseline to post-test (at 6 months); and change from baseline to follow up (at 12 months).

    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.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
• BackgroundBrickenkamp, R., & Zilmer, E. d2 Test of Attention (d2) [Database record]. APA PsycTests. 1998. Available from: https://doi.org/10.1037/t03299-000
• BackgroundCarvalho JS, Pereira S, Marques-Pinto N, Marôco A. Psychometric properties of the Mental Health Continuum-Short Form: A study of Portuguese speaking children/youths. Journal of Child and Family Studies. 2016;25(7):2141-54.
• BackgroundCoelho VA, Sousa V, Marchante M. Development and validation of the social and emotional competencies evaluation questionnaire. J Educ Develop Psychol [Internet]. 2015;5(1). Available from: http://dx.doi.org/10.5539/jedp.v5n1p139.
• BackgroundCoelho VA, Sousa V. Validação do questionário de avaliação de competências socioemocionais para alunos de 1o e 2o ciclo do ensino básico. Int J Dev Educ Psychol Rev INFAD psicol. 2020;2(1):431-40.
• Backgroundde Carvalho JS, Pinto AM, Marôco J. Results of a mindfulness-based social-emotional learning program on Portuguese elementary students and teachers: A quasi-experimental study. Mindfulness (N Y) [Internet]. 2017;8(2):337-50. Available from: http://dx.doi.org/10.1007/s12671-016-0603-z.
• BackgroundDias P, Gonçalves MS-C-C. Avaliação da ansiedade e da depressão em crianças e adolescentes (STAI-C-C2, CMAS-R, FSSC-R e CDI): Estudo normativo para a população portuguesa. In: Soares AP, Araújo S, Caires S, editors. Avaliação da ansiedade e da depressão em crianças e adolescentes. 1999. p. 553-64.
• Background: PubMed 11699809Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
• Background: PubMed 22023559Gullone E, Taffe J. The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA): a psychometric evaluation. Psychol Assess. 2012 Jun;24(2):409-17. doi: 10.1037/a0025777. Epub 2011 Oct 24.
• Background: PubMed 28631973Harris MA, Donnellan MB, Trzesniewski KH. The Lifespan Self-Esteem Scale: Initial Validation of a New Measure of Global Self-Esteem. J Pers Assess. 2018 Jan-Feb;100(1):84-95. doi: 10.1080/00223891.2016.1278380. Epub 2017 Feb 21.
• BackgroundHolder MD, Klassen A. Temperament and happiness in children. J Happiness Stud [Internet]. 2010;11(4):419-39. Available from: http://dx.doi.org/10.1007/s10902-009-9149-2.
• Background: PubMed 16981819Keyes CL. Mental health in adolescence: is America's youth flourishing? Am J Orthopsychiatry. 2006 Jul;76(3):395-402. doi: 10.1037/0002-9432.76.3.395.
• Background: PubMed 29333483Mather M, Thayer J. How heart rate variability affects emotion regulation brain networks. Curr Opin Behav Sci. 2018 Feb;19:98-104. doi: 10.1016/j.cobeha.2017.12.017.
• Individual participant dataSharing planned: No

Related trials for Mental Health Wellness 1

• Active, not recruiting

  Future School of Comprehensive Well-Being

  Learning, Comprehensive Wellbeing

• Not yet recruiting

  A Virtual Reality Program for Nursing Home Residents With Physical Disabilities

  Older Adults Institutionalized in Residential Homes

• RecruitingObservational study

  Friends/Family of Individuals at Risk of Suicide Training Program

  Caregiver, Caregiver Mental Health

• Recruiting

  GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults

  Sleep Disturbance, Stress

• Not yet recruitingPhase 1

  A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults

  Schizophrenia

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.

1 site in 1 country: see every site and its status.