- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06512844
MBSR for Improving Emotional Intelligence in Adolescents With Physical Disability
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
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
Study Overview
Status
Conditions
Intervention / Treatment
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 (e.g., 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 04403
- Aleeza Sohail
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The study would have the following inclusion criteria for participant recruitment.
Adolescents with physical disability including:
i. Orthopedic impairment ii. Traumatic brain injury iii. Sensory disability (vocally mute and partial visually impaired)
- Adolescents with physical disability in the age range 10-18
- Rural and urban residents
- Urdu, English and Punjabi speaking Participants who scored higher than cut off score on MAAS-A, DASS 21 SCS-SF, CATS and SSEIT in the phase I will be included in the phase II of the study i.e., Randomize control trail.
Exclusion Criteria:
Exclusion Criteria The study would have the following inclusion criteria for participant recruitment.
- Adolescents under age 10 and above 18
- Adolescents who are not willing to participate or their guardians did not give permission will be excluded from the present study.
Adolescents with physical disability such as:
i. Fully visual impairment ii. Hearing impairment iii. Deaf-blindness iv. Severe psychiatric issue
- Also, participant with any chronic or comorbid disease will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional Group
Participants who were assigned to interventional group were exposed to Urdu adapted and translated mindfulness-based stress reduction training.
These participants received 8 weeks of intervention.
|
The MBSR training program consist of 8-week group session with the duration of 45-60 minutes each.
Participants of the experimental group were given Mindfulness based stress reduction intervention in which they practice different mindfulness techniques.
Each week focused on motor, cognitive and emotional issues of students with physically disabled.
All the techniques also included psycho education
|
|
No Intervention: Control/Wait list Group
Participant who were assigned to Control Group did not receive any Intervention although they just received some relaxation breathing exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Intelligence
Time Frame: 8 weeks
|
Improvement in emotional intelligence as measured by Schuttle Self Report Emotional Intelligence Test scores.
The High Scores means more emotionally intelligent high Emotional Intelligence scores are typically above 123, average EI scores range from 90 to 122; and low EI scores are below 89 which means not that emotionally intelligent
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AleezaUW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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