Evaluation of the Effects of Passive Smoking and Parental Stress on Challenging Behaviors in Mentally Retarded Children With Urine Cotinine Levels (smoking)

November 13, 2024 updated by: Mukaddes Demir Acar, Tokat Gaziosmanpasa University
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 Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

special needs child

Description

Inclusion Criteria:

  • Children aged 5-10 with mental disabilities
  • Parents' ability to speak and understand Turkish
  • Parents' willingness to participate in the study

Exclusion Criteria:

Children who do not match the age group and do not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
smoking
not smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Child's Challenging Behaviour Scale 2 (CCBS-2)
Time Frame: 1 years
face to face
1 years
parent stress scaleparent stress scale parent stress scale Parent's Stress Scale
Time Frame: 1 years
Face to face
1 years
cotinin in urine
Time Frame: 1 years
urine analysis
1 years
sociodemographic questionnaire
Time Frame: 1 years
face to face
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TOGU2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

to be specific

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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