Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512844
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-29
Brief Title:
MBSR for Improving Emotional Intelligence in Adolescents With Physical Disability
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Mindfulness Based Intervention for the Management of Psychosocial Factors Associated With Emotional Intelligence in Adolescents With Physical Disability a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to provide evidence on the effectiveness of mindfulness-based interventions in enhancing emotional intelligence and managing psychosocial challenges in adolescents with physical disabilities potentially offering a valuable tool for improving their overall well-being
Does the mindfulness-based intervention improve emotional intelligence in adolescents with physical disabilities Does the psychosocial factors like psychological distress self-compassion improve during the intervention Are there any adverse effects associated with the mindfulness-based intervention Researcher will give intervention and compare the control and experimental group in Time 1 and Time 2 respectively
Does the mindfulness-based intervention improve emotional intelligence in adolescents with physical disabilities Does the psychosocial factors like psychological distress self-compassion improve during the intervention Are there any adverse effects associated with the mindfulness-based intervention Researcher will give intervention and compare the control and experimental group in Time 1 and Time 2 respectively
Detailed Description:
Title The Efficacy of Mindfulness-Based Intervention for the Management of Psychosocial Factors Associated with Emotional Intelligence in Adolescents with Physical Disability A Randomized Control Trial
Objective This clinical trial aims to evaluate the effectiveness of a mindfulness-based intervention MBI in managing psychosocial factors associated with emotional intelligence EI in adolescents with physical disabilities It also seeks to assess the safety and overall impact of the intervention
Main Questions
Does the mindfulness-based intervention improve emotional intelligence in adolescents with physical disabilities Does the psychosocial factors like psychological distress self-compassion improve during the intervention Are there any adverse effects associated with the mindfulness-based intervention
Study Design
Participants Adolescents aged 10-18 years with a diagnosed physical disability
Intervention Mindfulness-based intervention MBI compared to a control group receiving no intervention
Duration 8 weeks Follow-Up Participants will be assessed at baseline mid-intervention 4 weeks immediately post-intervention 8 weeks and at a 3-month follow-up
Methodology
Participants will be randomly assigned to one of two groups
Intervention Group Will participate in the mindfulness-based intervention which includes weekly mindfulness sessions and daily mindfulness practices at home
Control Group Will not receive any intervention but will continue with their usual activities along with some breathing exercises by the researcher
Procedures
Mindfulness Sessions Weekly group sessions led by a trained mindfulness instructor focusing on techniques such as meditation breathing exercises and body awareness
Daily Practice Participants in the intervention group will be instructed to practice mindfulness techniques daily and will receive support materials eg audio recordings practice guides
Assessment
Emotional Intelligence Measured using the Schulte Self-Report Emotional Intelligence Test SSEIT at all assessment points
Psychosocial Factors Evaluated using standardized questionnaires such as the Child and Adolescent Trauma Screen CATS and the Depression Anxiety and Stress Scales DASS
Adverse Effects Monitored through regular check-ins and a diary where participants can record any negative experiences
Visit Schedule
Baseline Visit Initial assessment and randomization Weekly Check-ins Short visits or calls to monitor progress and adherence Mid-Intervention 4 weeks Comprehensive assessment of EI and psychosocial factors
Post-Intervention 8 weeks Final assessment of EI and psychosocial factors collection of feedback on the intervention
3-Month Follow-Up Long-term assessment of sustained effects
Participant Responsibilities
Attend Weekly Sessions Attend all scheduled mindfulness sessions Daily Practice Engage in daily mindfulness exercises and record their practice
Keep a Diary Maintain a diary or emotional response log of their emotional state psychosocial experiences and any adverse effects
Outcome Measures
Primary Outcome Improvement in emotional intelligence as measured by SSEIT scores
Secondary Outcomes
Reduction in psychosocial distress as indicated by DASS scores Improvement in trauma-related symptoms as measured by CATS Monitoring and documentation of any adverse effects Significance This study aims to provide evidence on the effectiveness of mindfulness-based interventions in enhancing emotional intelligence and managing psychosocial challenges in adolescents with physical disabilities potentially offering a valuable tool for improving their overall well-being
Objective This clinical trial aims to evaluate the effectiveness of a mindfulness-based intervention MBI in managing psychosocial factors associated with emotional intelligence EI in adolescents with physical disabilities It also seeks to assess the safety and overall impact of the intervention
Main Questions
Does the mindfulness-based intervention improve emotional intelligence in adolescents with physical disabilities Does the psychosocial factors like psychological distress self-compassion improve during the intervention Are there any adverse effects associated with the mindfulness-based intervention
Study Design
Participants Adolescents aged 10-18 years with a diagnosed physical disability
Intervention Mindfulness-based intervention MBI compared to a control group receiving no intervention
Duration 8 weeks Follow-Up Participants will be assessed at baseline mid-intervention 4 weeks immediately post-intervention 8 weeks and at a 3-month follow-up
Methodology
Participants will be randomly assigned to one of two groups
Intervention Group Will participate in the mindfulness-based intervention which includes weekly mindfulness sessions and daily mindfulness practices at home
Control Group Will not receive any intervention but will continue with their usual activities along with some breathing exercises by the researcher
Procedures
Mindfulness Sessions Weekly group sessions led by a trained mindfulness instructor focusing on techniques such as meditation breathing exercises and body awareness
Daily Practice Participants in the intervention group will be instructed to practice mindfulness techniques daily and will receive support materials eg audio recordings practice guides
Assessment
Emotional Intelligence Measured using the Schulte Self-Report Emotional Intelligence Test SSEIT at all assessment points
Psychosocial Factors Evaluated using standardized questionnaires such as the Child and Adolescent Trauma Screen CATS and the Depression Anxiety and Stress Scales DASS
Adverse Effects Monitored through regular check-ins and a diary where participants can record any negative experiences
Visit Schedule
Baseline Visit Initial assessment and randomization Weekly Check-ins Short visits or calls to monitor progress and adherence Mid-Intervention 4 weeks Comprehensive assessment of EI and psychosocial factors
Post-Intervention 8 weeks Final assessment of EI and psychosocial factors collection of feedback on the intervention
3-Month Follow-Up Long-term assessment of sustained effects
Participant Responsibilities
Attend Weekly Sessions Attend all scheduled mindfulness sessions Daily Practice Engage in daily mindfulness exercises and record their practice
Keep a Diary Maintain a diary or emotional response log of their emotional state psychosocial experiences and any adverse effects
Outcome Measures
Primary Outcome Improvement in emotional intelligence as measured by SSEIT scores
Secondary Outcomes
Reduction in psychosocial distress as indicated by DASS scores Improvement in trauma-related symptoms as measured by CATS Monitoring and documentation of any adverse effects Significance This study aims to provide evidence on the effectiveness of mindfulness-based interventions in enhancing emotional intelligence and managing psychosocial challenges in adolescents with physical disabilities potentially offering a valuable tool for improving their overall well-being
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None