Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment

NCT06228950 | Unknown

• 1 other identifier: FJWU/EC/2023/65
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Current study will be conducted on the Effectiveness of Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students with Visual Impairment. Mindfulness-based Intervention that is Mindfulness-Based Stress Reduction (MBSR) will be used in the current study which is adapted and translated in Urdu language; the pilot trial of MBSR will be conducted after adaptation and translation. The present study will be conducted in two phases

• First phase of the study would be a cross-sectional survey in which the researcher will conduct a baseline assessment to identify psychosocial predictors such as psychological distress, parental acceptance and rejection, social support, and mindfulness which are associated with the emotional and behavioural problems of students with visual impairment. Further emotional and behavioural problems of the students with visual impairment will identify.
• The second phase of the research would be a Randomized Controlled Trial in which students with Visual Impairment who has scored high on psychosocial predictors and emotional \& behavioural problems would be randomly assigned to intervention \& control groups to get the MBSR training. After the successful training post-assessment would be conducted to check the efficacy of MBSR.
• The current study will be conducted in Rawalpindi Islamabad after obtaining permission from the relevant authorities.
• Data would be collected from the students with visual impairment and their respective parents.

Conditions

Emotional Problem; Behavior Problem

Keywords

Emotional and Behavioural Problems Mindfulness Students

Outcome Measures

Primary Outcomes (2)

• Strength and Difficulties Questionnaire (Self Report Version)

  It has 25 items, with subscales that generate scores for emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behaviour. It is a 3-point Likert-type scale. The Self Report Version score ranges from minimum to maximum which is 0 to 50. Low scores indicate better outcomes and high scores indicate worse outcomes which is high Emotional and Behavioural Problems in students with visual impairment.

  2 Months

• Strength and Difficulties Questionnaire (Parent Report Version)

  It has 25 items that measures the same attributes as the self-report version. It is a 3-point Likert type scale. The Parent Report Version score ranges from minimum to maximum which is 0 to 50. Low scores indicate better outcomes whereas high scores indicate worse outcomes that is high Emotional and Behavioural Problems in students with visual impairment.

  2 Months

Secondary Outcomes (4)

• Depression Anxiety Stress Scale-21

  2 Months

• Child Parent Acceptance-Rejection Questionnaire

  2 Months

• Multidimensional Scale of Perceived Social Support

  2 Months

• Mindfulness Attention Awareness Scale-Adolescents

  2 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

A structured MBSR training for this study will be given to the intervention group of students with visual impairment. The intervention will include body scan, sitting meditation, yoga, breathing exercises, guided mindfulness, loving kindness, etc exercises to improve the emotional and behavioural problems of students with visual impairment.

Behavioral: Mindfulness-Based Stress Reduction

Wait-list Control Group

NO INTERVENTION

The Wait-list control group will receive no intervention. This group will serve as a comparison group to evaluate the specific effect of the mindfulness based intervention.

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

A therapeutic approach called mindfulness-based stress reduction, or MBSR, aims to reduce emotional and behavioral problems by fostering mindfulness, which is an impartial awareness of the present moment. MBSR will be an 8-week training course for students with visual impairment. MBSR training, translated and adapted in Urdu language that includes 8 audios and worksheets corresponding to each week. Worksheets to record home practice will be filled upon receiving oral feedback from the students with visual impairment. Face-to-face group-based sessions will be conducted weekly.

Intervention Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents and their children who will be in the age range of at least 13-17 years will be included in the present study. All students who will participate in this study will be partially or completely visually impaired.
• Participants who scored higher on DASS-21, PARQ, SDQ self, and SDQ parent report form and low on MSPSS and MAAS-A in phase I will be included in phase II of the study i.e. Randomized Control Trial.

You may not qualify if:

• Participants who have gone through critical medical conditions like psychological treatment or surgery or have co-morbid problems would be excluded.

Sponsors & Collaborators

• Fatima Jinnah Women University: lead

Study Sites (1)

Tehmeena Hanif

Rawalpindi, 00666, Pakistan

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tehmeena Hanif, PhD Scholar

  Fatima Jinnah Women University Rawalpindi Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tehmeena Hanif, Ph.D Scholar

CONTACT

+923335642062; 20-20241-005@bhs.fjwu.edu.pk

Dr. Iram Gul, Ph.D

CONTACT

+923335501909; iramgul@fjwu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind, neither the participant nor the investigator know what they are getting
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled trial (RCT) design will be used in this interventional study to evaluate the effectiveness of mindfulness-based intervention for emotional and behavioral problems of students with visual impairment. Participants in RCT will be randomized in the intervention and the control group. Urdu-translated and adaptive mindfulness-based intervention that is MBSR designed specifically to meet the needs of students with visual impairment will be given to the intervention group. The MBSR training program consisted of 8-week group sessions with a duration of 50 to 90 minutes each for a group of 5-8 members. The intervention will include a body scan, sitting meditation, yoga, breathing exercises, guided mindfulness exercises, loving kindness etc to improve emotional and behavioral problems. Standardized measures will be used to evaluate changes in pre and post-intervention.

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 29, 2024
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)