Smoking BehaviorsmokingNCT06691022
Evaluation of the Effects of Passive Smoking and Parental Stress on Challenging Behaviors in Mentally Retarded Children With Urine Cotinine Levels
An observational study of Smoking Behavior and Special Needs Child, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Smoking Behavior, Special Needs Child
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2023to 1 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: special needs child
Who may be able to join
- Children aged 5-10 with mental disabilities
- Parents' ability to speak and understand Turkish
- Parents' willingness to participate in the study
Who cannot join
- Children who do not match the age group and do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children
Read the detailed description
This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children
- Conditions
- Smoking Behavior, Special Needs Child
- Keywords
- smoking, Child's Challenging Behaviour, parents, stres
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| smoking | not smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Child's Challenging Behaviour Scale 2 (CCBS-2)
face to face
Measured: 1 years
parent stress scaleparent stress scale parent stress scale Parent's Stress Scale
Face to face
Measured: 1 years
cotinin in urine
urine analysis
Measured: 1 years
sociodemographic questionnaire
face to face
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start23 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukaddes Demir Acar, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691022
- Sponsor's protocol ID
- TOGU2023
- Acronym
- smoking
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to be specific
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Passive Smoking and Parental Stress on Challenging Behaviors in Mentally Retarded Children With Urine Cotinine Levels
- ClinicalTrials.gov ID
- NCT06691022
- Acronym / sponsor ID
- smoking / TOGU2023
- Conditions
- Smoking Behavior, Special Needs Child
- Keywords
- smoking, Child's Challenging Behaviour, parents, stres
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 15 Nov 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.
This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children
Detailed description
This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smoking | – | –not smoking |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- special needs child
Key inclusion criteria (3 listed)
- Children aged 5-10 with mental disabilities
- Parents' ability to speak and understand Turkish
- Parents' willingness to participate in the study
Key exclusion criteria (1 listed)
- Children who do not match the age group and do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Child's Challenging Behaviour Scale 2 (CCBS-2)
Time frame: 1 years
face to face
parent stress scaleparent stress scale parent stress scale Parent's Stress Scale
Time frame: 1 years
Face to face
cotinin in urine
Time frame: 1 years
urine analysis
sociodemographic questionnaire
Time frame: 1 years
face to face
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No. to be specific
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Behavior and Special Needs Child, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 3 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: enrolling by invitation, as of the sponsor's last update on 15 Nov 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
The Child's Challenging Behaviour Scale 2 (CCBS-2) (time frame: 1 years). The study lists 4 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 15 Nov 2024.