ClinicalTrials.gg
RecruitingNCT06228950Updated Jan 29, 2024

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

An interventional study of Mindfulness-Based Stress Reduction in Emotional Problem and Behavior Problem, sponsored by Fatima Jinnah Women University. Recruiting at 1 site in Pakistan. Open to participants aged 13 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Fatima Jinnah Women University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2024).
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study 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.
Read the detailed description

The study is designed to assess the Emotional and Behavioural Problems (EBPs) of Students with Visual Impairment studying at special education schools for impaired vision and to evaluate the relationship between the scores of psychosocial predictors that are associated with EBPs and selected demographic variables of these students. According to a literature review among all types of disabilities, a high occurrence of psychological disorder was found in VI children. So, the present study aimed to assist students with visual impairment in controlling the occurrence of different emotional and behavioural problems. Additionally, the current study will be advantageous for instructors, coaches, and policymakers to consider the role of educational psychologists in special school settings. Visual impairment can cause problems in daily life, but a person with sound mental health can better deal with it. So, the present study will contribute a lot to society by improving the life quality of these special children. Students with visual impairment in their school settings will utilize the practice of MBSR to reduce stress and to increase their emotional and adaptive behaviours. The purpose of current research is to integrate mindfulness practices in special school settings to provide the behavioural support for adolescents with visual disabilities so that they can be more successful both socially and academically.

Sample The present study will be conducted with students who will be Visually Impaired (partial or complete). Data will also be collected from their respective parents. The sample will be taken from different schools of blinds, centers, and special schools in Rawalpindi/Islamabad. The age group of samples will range from 13 to 17 years. Purposive sampling will be used and those participants will be selected who will be available and volunteer to participate at the time of data collection. Data will be collected in one-on-one interviews by oral administration of questionnaires.

MBSR will be translated and adapted into Urdu language. Permission to translate into Urdu language will be taken from the relevant authority. In the first phase, participants will be initially asked about demographic variables. The researcher would identify the psychosocial predictors of emotional and behavioural problems of students with Visual Impairment based on the scores of Depression Anxiety Stress Scale-21 (DASS-21), Parental Acceptance and Rejection Questionnaire (Child PARQ), Multidimensional Scale of Perceived Social Support (MSPSS) and Mindfulness Attention Awareness Scale-Adolescents (MAAS-A). Further emotional and behavioural problems of the students with visual impairment will identify by SDQ Self and SDQ Parent report form scores. Participants will be assured about the confidentiality of the data and its findings that will only be used for the cause of the research project.

In the second phase cohort would be identified from the participants who would score high on DASS-21, Child PARQ, SDQ Self, and SDQ Parent report form and low on MSPSS \& MAAS-A. They would be screened out as potential cohorts for Randomized Control trials (RCT). Participants would be randomly assigned to interventional and control groups by using the random number method. Participants who would be assigned to the interventional group will be exposed to the Urdu-translated and adapted Mindfulness-Based Stress Reduction (MBSR) training. Students who would be assigned to the interventional group will receive 8 weeks of therapeutic intervention however the students who are randomly assigned to the control group will be given no intervention. The MBSR training program consisted of 8-week group sessions with a duration of 50 to 90 minutes each. Each week will focus on a particular theme related to the emotional and behavioural problems of students with Visual Impairment. After the successful completion of 8 weeks of MBSR training both groups will appear for post-assessment. The same aforementioned measures will be used in post-assessment.

02

Conditions studied

  • Emotional Problem
  • Behavior Problem

Browse trials for

Keywords

  • Emotional and Behavioural Problems Mindfulness Students
03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,301 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Fatima Jinnah Women University is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criterion will be; students and parents who would not be willing to participate and who refuse to give consent. Other disabilities in students will not be considered (e.g. hearing disability or other physical disabilities).
  • Participants who have gone through critical medical conditions like psychological treatment or surgery or have co-morbid problems would be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    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

  • No intervention
    Wait-list Control Group

    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

  • BehavioralMindfulness-Based Stress Reduction

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 Months

  2. 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.

    Time frame: 2 Months

Secondary outcomes

  1. Depression Anxiety Stress Scale-21

    Depression Anxiety Stress Scale-21 is a comprehensive measure for depression, anxiety, and stress. it is a four-point Likert-type scale. The score ranges from minimum to maximum which is 0 to 63. Low scores indicate better outcomes whereas high scores indicate worse outcomes that is high Psychological Distress.

    Time frame: 2 Months

  2. Child Parent Acceptance-Rejection Questionnaire

    It is a self-report measure to identify perception of individual about the parental treatment that he/she received during childhood. It has four subscales that are Warmth/Affection, Hostility/Aggression, Indifference/Neglect, and Undifferentiated rejection. It has two versions; mother and father. Each consists of 24 items on a 4 point Likert-type scale. The score range of the scale from minimum to maximum is 24 to 96. Low scores indicate the better outcome which is the lowest rejection and highest acceptance whereas high scores indicate the worse outcome which is the highest rejection and lowest acceptance.

    Time frame: 2 Months

  3. Multidimensional Scale of Perceived Social Support

    It is a self-report inventory which is used to assess persons' perception of social support that they receive from the family, friends or significant others in stressful situations. It contains 12 items with 7 point likert type scale. The score range of the scale from minimum to maximum is 12 to 84. Low scores indicate a worse outcome that is low level of perceived social support whereas as high score indicate better outcome.

    Time frame: 2 Months

  4. Mindfulness Attention Awareness Scale-Adolescents

    It is a 14-item scale measuring the development of mindfulness. The score range of the scale from minimum to maximum is 14 to 84. Low scores indicate a worse outcome that is low level of mindfulness whereas a high score indicates a better outcome.

    Time frame: 2 Months

07

Study locations

1 of 1 sites recruiting
  • Tehmeena Hanif
    Rawalpindi, 00666, Pakistan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jun 2024, 9 months after the start.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 9 months is below that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2024
First posted
Jan 29, 2024
StartActual
Sep 1, 2023
Primary completionEst.
Jun 30, 2024
CompletionEst.
Dec 31, 2024
Last update
Jan 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06228950
Lead sponsor
Fatima Jinnah Women University
Responsible party
Tehmeena Hanif (Principal Investigator, Fatima Jinnah Women University) — Principal investigator
First posted
Jan 29, 2024
Start date
Sep 1, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 29, 2024

Study contacts

Tehmeena Hanif, Ph.D Scholar
Contact
20-20241-005@bhs.fjwu.edu.pk
+923335642062
Dr. Iram Gul, Ph.D
Contact
iramgul@fjwu.edu.pk
+923335501909
Tehmeena Hanif, PhD Scholar
principal investigator · Fatima Jinnah Women University Rawalpindi Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion