Emotional ProblemNCT06228950
Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment
A study testing Mindfulness-Based Stress Reduction in people with Emotional Problem and Behavior Problem, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Problem, Behavior Problem
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Tehmeena Hanif
Rawalpindi, 00666
Tehmeena Hanif, Ph.D, +923335642062, 20-20241-005@bhs.fjwu.edu.pk
About this study
Official title: Effectiveness of Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment
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.
- Conditions
- Emotional Problem, Behavior Problem
- Being tested
- Mindfulness-Based Stress Reduction
- Keywords
- Emotional and Behavioural Problems Mindfulness Students
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 Months
Secondary outcomes (4)
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.
Measured: 2 Months
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.
Measured: 2 Months
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.
Measured: 2 Months
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.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tehmeena Hanif, Fatima Jinnah Women University
- Investigators
- Tehmeena Hanif, PhD Scholar, Principal investigator, Fatima Jinnah Women University Rawalpindi Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228950
- Sponsor's protocol ID
- FJWU/EC/2023/65
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment
- ClinicalTrials.gov ID
- NCT06228950
- Acronym / sponsor ID
- FJWU/EC/2023/65
- Conditions
- Emotional Problem, Behavior Problem
- Keywords
- Emotional and Behavioural Problems Mindfulness Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindfulness-Based Stress ReductionA 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. |
| 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionA 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. | Behavioural | Intervention Group |
Primary outcome
Strength and Difficulties Questionnaire (Self Report Version)
Time frame: 2 Months
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.
Strength and Difficulties Questionnaire (Parent Report Version)
Time frame: 2 Months
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.
4 secondary outcomes
Depression Anxiety Stress Scale-21
Time frame: 2 Months
Child Parent Acceptance-Rejection Questionnaire
Time frame: 2 Months
Multidimensional Scale of Perceived Social Support
Time frame: 2 Months
Mindfulness Attention Awareness Scale-Adolescents
Time frame: 2 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehmeena Hanif, PhD Scholar principal investigator
Fatima Jinnah Women University Rawalpindi Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Emotional Problem and Behavior Problem, run by Fatima Jinnah Women University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tehmeena Hanif, Ph.D Scholar (+923335642062, 20-20241-005@bhs.fjwu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength and Difficulties Questionnaire (Self Report Version) (time frame: 2 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.