Mental Health Issue(CSI)NCT06080685
Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents
A study testing Character Strengths Intervention in people with Mental Health Issue and Mutism, run by Fatima Jinnah Women University at 3 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Mutism, Orthopedic Disorder
- What is being tested?
- Character Strengths Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesPakistan
- Study dates
- 23 Sep 2023to 15 Dec 2023
- 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents with physical disability
- Adolescents with physical disability in the age range 11-18
- Rural and urban residences
- Urdu, Englishspeaking
- Rawalpindi and Islamabad special education schools
Who cannot join
- Adolescents under age 11 and above 18
- Adolescents whose parents, teachers, or themselves would not be agreed and signed informed consent to participate in the study would be excluded
- Adolescents with physical disability such as:
- Sensory disability (mute and Fully/partial-visual impairment) impairment
- Hearing impairment
- Deaf-blindness
- And intellectual and cognitive impairment
- Adolescents with severe psychiatric and major medical issues -
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Directorate General of Specials Education
Islamabad, Captial
Al-Ghazali Special Education School
Rawalpindi, Punjab Province, 46000
Army Public Special Education Centre
Rawalpindi, Punjab Province, 46000
About this study
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:
Read more
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.
- Conditions
- Mental Health Issue, Mutism, Orthopedic Disorder
- Being tested
- Character Strengths Intervention
- Keywords
- Adolescents with physical disability
- Medical subject headings
- Mutism, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Character Strengths InterventionBehavioural
Also called Positive Psychology Interventions
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Who receives intervention. Character strengths intervention will be administered in 5 sessions. Receives: Behavioral: Character Strengths Intervention |
| Waitlist Control Group | Active comparator | Who would receive the intervention after the study completion. Receives: Behavioral: Character Strengths Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-esteem
10-item scale "Rosenberg Self-esteem Scale" used to measure.
Measured: 1 month
Character strengths
98 items scale "The Values in Action (VIA) Youth Survey" is used.
Measured: 1 month
Secondary outcomes (3)
Psychological wellbeing
14 Items scale "the Warwick-Edinburgh Mental Well-being Scale (WEMWBS)" is used to measure psychological wellbeing.
Measured: 1 month
Life Satisfaction
5 items scale "Satisfaction with Life Scale" is used.
Measured: 1 month
Resilience
10 items "Connor-Davidson Resilience Scale (CD-RISC-10)" is used.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start23 Sep 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Rashid, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080685
- Sponsor's protocol ID
- FJWU/EC/2023/61
- Other IDs
- FJWU/EC/2023/61
- Acronym
- (CSI)
- Status last verified
- Jan 2024
- First submitted
- 27 Sep 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents
- ClinicalTrials.gov ID
- NCT06080685
- Acronym / sponsor ID
- (CSI) / FJWU/EC/2023/61
- Conditions
- Mental Health Issue, Mutism, Orthopedic Disorder
- Keywords
- Adolescents with physical disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 12 Oct 2023 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Character Strengths InterventionWho receives intervention. Character strengths intervention will be administered in 5 sessions. |
| Waitlist Control Group | Active comparator | Behavioral: Character Strengths InterventionWho would receive the intervention after the study completion. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents with physical disability
- Adolescents with physical disability in the age range 11-18
- Rural and urban residences
- Urdu, Englishspeaking
- Rawalpindi and Islamabad special education schools
Key exclusion criteria (8 listed)
- Adolescents under age 11 and above 18
- Adolescents whose parents, teachers, or themselves would not be agreed and signed informed consent to participate in the study would be excluded
- Adolescents with physical disability such as:
- Adolescents with severe psychiatric and major medical issues -
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 |
|---|---|---|
| Character Strengths InterventionAlso: Positive Psychology InterventionsSession 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. | Behavioural | Intervention Group, Waitlist Control Group |
Primary outcome
Self-esteem
Time frame: 1 month
10-item scale "Rosenberg Self-esteem Scale" used to measure.
Character strengths
Time frame: 1 month
98 items scale "The Values in Action (VIA) Youth Survey" is used.
3 secondary outcomes
Psychological wellbeing
Time frame: 1 month
Life Satisfaction
Time frame: 1 month
Resilience
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Character Strengths Intervention in people with Mental Health Issue and Mutism, run by Fatima Jinnah Women University at 3 sites 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-esteem (time frame: 1 month). 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 1 Feb 2024.