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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06080685
Other study ID # FJWU/EC/2023/61
Secondary ID FJWU/EC/2023/61
Status Completed
Phase N/A
First received
Last updated
Start date September 23, 2023
Est. completion date December 15, 2023

Study information

Verified date January 2024
Source Fatima Jinnah Women University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to better understand the experiences of adolescents with physical disabilities and assess the effectiveness of a Character Strengths Intervention (CSI) in improving their self-esteem, character strengths, and mental health. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment. Main Research Questions: How do adolescents with physical disabilities perceive their self-esteem, character strengths, and mental health, including psychological adjustment, psychological distress, psychological wellbeing, life satisfaction, and resilience? Can the Character Strengths Intervention (CSI) enhance the self-esteem, character strengths, and mental health (psychological adjustment and distress) of adolescents with physical disabilities? Study Tasks: Participants, who are adolescents aged 12-18 years, will be asked to provide informed consent to participate in the study. They will complete questionnaires to assess their self-esteem, character strengths, and mental health as a pre-assessment. Participants in the intervention group will undergo the Character Strengths Intervention (CSI), which includes activities like exploring character strengths, writing gratitude letters, and practicing fresh look meditation, among others. After the intervention, participants will complete post-assessment questionnaires to measure changes in self-esteem, character strengths, and mental health. There will be a control group that does not receive any treatment. Comparison Group: Researchers will compare the outcomes between the intervention group, who received the Character Strengths Intervention (CSI), and the control group, who did not receive any treatment. This will help us determine if the intervention had a significant impact on self-esteem, character strengths, and mental health outcomes for adolescents with physical disabilities.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria: 1. Adolescents with physical disability 2. Adolescents with physical disability in the age range 11-18 3. Rural and urban residences 4. Urdu, Englishspeaking 5. Rawalpindi and Islamabad special education schools Exclusion Criteria: 1. Adolescents under age 11 and above 18 2. Adolescents whose parents, teachers, or themselves would not be agreed and signed informed consent to participate in the study would be excluded 3. Adolescents with physical disability such as: - Sensory disability (mute and Fully/partial-visual impairment) impairment - Hearing impairment - Deaf-blindness - And intellectual and cognitive impairment 4. Adolescents with severe psychiatric and major medical issues -

Study Design


Intervention

Behavioral:
Character Strengths Intervention
Session 1. Getting Started: Introducing and Exploring Character Strengths Session 2. Boost a Lower Strength Session 3. Cultivate your inner self + Loving-Kindness Meditation Session 4. Gratitude Letter + Three Good things Session 5. Conclusion Each session will consist of 1-hour, which will be delivered once a week for 5 weeks. Moreover, participants will be given homework which they will practice the rest of the week.

Locations

Country Name City State
Pakistan Directorate General of Specials Education Islamabad Captial
Pakistan Al-Ghazali Special Education School Rawalpindi Punjab
Pakistan Army Public Special Education Centre Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Fatima Jinnah Women University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-esteem 10-item scale "Rosenberg Self-esteem Scale" used to measure. 1 month
Primary Character strengths 98 items scale "The Values in Action (VIA) Youth Survey" is used. 1 month
Secondary Psychological wellbeing 14 Items scale "the Warwick-Edinburgh Mental Well-being Scale (WEMWBS)" is used to measure psychological wellbeing. 1 month
Secondary Life Satisfaction 5 items scale "Satisfaction with Life Scale" is used. 1 month
Secondary Resilience 10 items "Connor-Davidson Resilience Scale (CD-RISC-10)" is used. 1 month
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