Well-being, Emotional and Behavioral Problems, AdolescentsNCT06065579
Efficacy of Well-Being Promotion Program for Management of Emotional and Behavioural Problems Among Adolescents
A study testing Well-Being Promotion Program in people with Well-being, Emotional and Behavioral Problems, Adolescents, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
The objectives of the study are given as under; 1. To examine the efficacy of the Well-being Promotion Program in enhancing subjective well-being, positive affect, life satisfaction and reducing emotional /behavioral problems , negative affect among adolescents with emotional and behavioral problems. 2. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being, Emotional and Behavioral Problems, Adolescents
- What is being tested?
- Well-Being Promotion Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to Nov 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Inclusion Criteria Only those participants who meet the category of moderate level of emotional and behavioural problems through Strength and difficulty Questionnaire (SDQ; Urdu Version) (Samad et al., 2005) will be selected for the study.
Who cannot join
- Exclusion Criteria Those participants who meet high levels of emotional and behavioural problems through Strength and difficulty Questionnaire (SDQ; Urdu Version) (Samad et al., 2005) will not be selected for the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Madiha Arshad
Sukkur, 46300
Madiha Arshad, PhD Scholar, +92 3365117537, madiharshad93@gmail.com
About this study
Official title: Efficacy of Well-Being Promotion Program for Management of Emotional and Behavioural Among Adolescents
The objectives of the study are given as under;
- To examine the efficacy of the Well-being Promotion Program in enhancing subjective well-being, positive affect, life satisfaction and reducing emotional /behavioral problems , negative affect among adolescents with emotional and behavioral problems.
- To examine the differences in terms of subjective well-being, emotional / behavioral problems , positive / negative affect and life satisfaction between the treatment and control group after intervention.
- To examine the differences in terms of subjective well-being, emotional / behavioral problems, positive / negative affect and life satisfaction in the intervention group at (T1) before and at (T2) after intervention.
Read the detailed description
In this study, adolescents within age range ( 14-19years) will participates in the study because this study focus on the emotional and behavioral problems and their low level of well-being and life satisfaction among adolescents. Adolescence is a developmental period in which dramatically emotional changes occur which may be the result of biological changes such as secretions of hormones. Chances of psychological distress are increased due to emotional changes. Depression and anxiety are most common psychopathology in adolescents (Ma \& Fang, 2019). Child turns out to be independent, gradually deals with the external world and starts taking his/her decisions such as selection of subjects, peer pressure and so on. Thus , it is important to focus on mental health and management of emotional and behavioral problems.
- Being tested
- Well-Being Promotion Program
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being Promotion ProgramOther
the well-being promotion program (Suldo,2016) , an intervention designed to improve subjective well-being. It was postulated that this intervention will eventually assist in managing emotional and behavioural problems among adolescents enrolled in the program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group will receive intervention Receives: Other: Well-Being Promotion Program |
| Control Group | No intervention | Control group will not receive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional and Behavioural Problems Among Adolescents
Emotional and behavioural problems will be measured through the Strength and Difficulty Questionnaire(SDQ- Urdu Version) (Samad et al., 2005). High score on the Strength and Difficulty Questionnaire(SDQ- Urdu Version indicates more emotional and behavioural Problems .
Measured: 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Aug 2023
- Primary completion5 Sep 2023
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-being, Emotional and Behavioral Problems, AdolescentsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Arshad, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065579
- Sponsor's protocol ID
- JinnahWU
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Well-Being Promotion Program for Management of Emotional and Behavioural Among Adolescents
- ClinicalTrials.gov ID
- NCT06065579
- Acronym / sponsor ID
- JinnahWU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- Nov 2023 (estimated)
- First posted
- 4 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 objectives of the study are given as under;
- To examine the efficacy of the Well-being Promotion Program in enhancing subjective well-being, positive affect, life satisfaction and reducing emotional /behavioral problems , negative affect among adolescents with emotional and behavioral problems.
- To examine the differences in terms of subjective well-being, emotional / behavioral problems , positive / negative affect and life satisfaction between the treatment and control group after intervention.
- To examine the differences in terms of subjective well-being, emotional / behavioral problems, positive / negative affect and life satisfaction in the intervention group at (T1) before and at (T2) after intervention.
Detailed description
In this study, adolescents within age range ( 14-19years) will participates in the study because this study focus on the emotional and behavioral problems and their low level of well-being and life satisfaction among adolescents. Adolescence is a developmental period in which dramatically emotional changes occur which may be the result of biological changes such as secretions of hormones. Chances of psychological distress are increased due to emotional changes. Depression and anxiety are most common psychopathology in adolescents (Ma \& Fang, 2019). Child turns out to be independent, gradually deals with the external world and starts taking his/her decisions such as selection of subjects, peer pressure and so on. Thus , it is important to focus on mental health and management of emotional and behavioral problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Well-Being Promotion ProgramIntervention group will receive intervention |
| Control Group | No intervention | –Control group will not receive intervention |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Inclusion Criteria Only those participants who meet the category of moderate level of emotional and behavioural problems through Strength and difficulty Questionnaire (SDQ; Urdu Version) (Samad et al., 2005) will be selected for the study.
Key exclusion criteria (1 listed)
- Exclusion Criteria Those participants who meet high levels of emotional and behavioural problems through Strength and difficulty Questionnaire (SDQ; Urdu Version) (Samad et al., 2005) will not be selected for the study.
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 |
|---|---|---|
| Well-Being Promotion Programthe well-being promotion program (Suldo,2016) , an intervention designed to improve subjective well-being. It was postulated that this intervention will eventually assist in managing emotional and behavioural problems among adolescents enrolled in the program. | Other | Intervention Group |
Primary outcome
Emotional and Behavioural Problems Among Adolescents
Time frame: 2.5 months
Emotional and behavioural problems will be measured through the Strength and Difficulty Questionnaire(SDQ- Urdu Version) (Samad et al., 2005). High score on the Strength and Difficulty Questionnaire(SDQ- Urdu Version indicates more emotional and behavioural Problems .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Promotion Program in people with Well-being, Emotional and Behavioral Problems, Adolescents, 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 1 inclusion and 1 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 4 Oct 2023. 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 Madiha Arshad, PhD scholar (+92 3365117537, madiharshad93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional and Behavioural Problems Among Adolescents (time frame: 2.5 months). 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 4 Oct 2023.