Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: a Multi-arm Psychometric Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pisa
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Temperament - Social Orientation (SO)
Study Overview
Brief Summary
Background and study aims:
Mindfulness is a mental state that can be achieved through meditation. So far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. Mindfulness has recently begun to be used in the field of child development. The aim of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperament.
Who can participate? Students attending the fourth or fifth year of primary school
What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions, while the control group will follow routine daily school activities.
Questionnaires will be used to assess temperament, anxiety and depression before and after the intervention.
What are the possible benefits and risks of participating? Benefits of participating in the study may include a lowering of anxiety and depression levels, as well as an improvement of temperament.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 9 to 11 years
- •Children have reasonable comprehension of spoken language and can follow simple instructions
- •Children and their parents are willing to attend all intervention sessions
- •Children and parents have an adequate understanding of English
Exclusion Criteria
- •Concurrent enrollment in other intervention trials
- •Child or parent regularly practice complementary health interventions such as meditation
Arms & Interventions
Mindfulness
Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions
Intervention: Mindfulness-based intervention (Behavioral)
Control
The control group will follow routine daily school activities
Outcomes
Primary Outcomes
Temperament - Social Orientation (SO)
Time Frame: QUIT-SO is measured before and after the 8-week mindfulness intervention
SO dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Negative Emotionality (NE)
Time Frame: QUIT-NE is measured before and after the 8-week mindfulness intervention
NE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Temperament - Inhibition to Novelty (IN)
Time Frame: QUIT-IN is measured before and after the 8-week mindfulness intervention
IN dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Temperament - Attention (AT)
Time Frame: QUIT-AT is measured before and after the 8-week mindfulness intervention
AT dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Positive Emotionality (PE)
Time Frame: QUIT-PE is measured before and after the 8-week mindfulness intervention
PE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Motor Activity (MA)
Time Frame: QUIT-MA is measured before and after the 8-week mindfulness intervention
MA dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). No overall change is expected in MA scores
Secondary Outcomes
- Anxiety(TAD for Anxiety is measured before and after the 8-week mindfulness intervention)
- Depression(TAD for Depression is measured before and after the 8-week mindfulness intervention)
Investigators
Andrea Poli
Dr.
University of Pisa