The Effect of a Zero Tolerance Program (SToP) on Child's Urine Cotinine Level According to Exposure Feedback

Child Clinical Trial

— SToP  

Official title:

The Effect of a Zero Tolerance Program (SToP) Applied to Parents of Children at High Risk of Secondhand Tobacco Smoke Exposure on Child's Urine Cotinine Level According to Exposure Feedback: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545748
• Other study ID #: 0015
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: May 2, 2024

Study information

• Verified date: March 2024
• Source: Akdeniz University
• Contact: Sebahat Gözüm, Professor
• Phone: +905332841250
• Email: sgozum[@]akdeniz.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although the ban on indoor smoking has greatly reduced secondhand smoke (SHS) exposure in public spaces, the home environment is still the primary source of exposure to SHS, particularly in children under the age of five. Although attempts are often made to prevent or reduce children's exposure to SHS, such as education, counseling, and exposure feedback to parents, exposure remains. Although using materials such as brochures, messages, posters and reminders that will minimize the harms such as protecting children from SHS will reduce the exposure, exposure continues in the long term.The aim of this study is to compare the effect of giving exposure feedback to the parents according to the zero tolerance program (SToP) on the urinary cotinine level of the children. In this study with active control group, single-blind (participant), randomized control, stratified block randomization (1:1) will be performed. Totally 58 participants including STOP intervention group (n:29) and the exposure feedback group (n:29), which is the active control group, were planned to be included in the study, which was planned to be conducted between January and September 2023. Cotinine-sensitive dipstick test kits will be used for the primary outcome (urine cotinine). Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample. Secondary outcomes will be evaluated by information form on exposure to second-hand smoke, an attitude form on exposure to second-hand smoke, and a scale of beliefs towards third-hand smoke. This protocol will demonstrate whether SToP interventions, a sustainable program for children at high risk of secondhand tobacco exposure, are a viable intervention for parents on how to reduce exposure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: May 2, 2024
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parents with children aged 5 and under, whose children are registered with the Family Health Center, and whose children are at high and very high risk of exposure to SHS according to the risk algorithm.

• Parents' willingness to participate in the study

Exclusion Criteria:

• Babysitter

• Those who do not speak Turkish.

• Parents of children with asthma will not be included on the grounds that it may be confusing as they may display more specific behavior.

Related Conditions & MeSH terms

• Child
• Exposure to Environmental Pollution
• Parents
• Second Hand Smoke
• Urine

Intervention

Behavioral:
• Zero (0) Tolerance Program (SToP)
Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score mean. Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample. Giving reminder objects (Magnet, sticker): For example; at the entrance door of the house: "0 TOLERANCE" magnet to cigarettes; "No smoking in my home" label. Informative materials (information notes and brochures): Brochures on the harms of second-hand smoking (SHS) and third-hand smoking (THS), the diseases they cause, and how to protect them Informative telephone text messages: Reminder phone messages related to SHS and THS
• Exposure Feedback Group
1. Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score mean. Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample.

Locations

Country	Name	City	State
Turkey	Sebahat Gözüm	Antalya

Sponsors (2)

Lead Sponsor	Collaborator
Akdeniz University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Cotinine Level	The child's urine sample taken at any time will be analyzed with the cotinine-sensitive dipstick test kit to assess the urine cotinine level. Urine samples will be tested in accordance with the manufacturer's instructions. The test has over 99% sensitivity in detecting cotinine with a cut-off level of 200 ng/ml and a minimum detection time of 2-8 hours and a maximum detection time of 1-7 days. After the test is immersed in the urine collection container for 10 seconds, the result becomes clear within 5 minutes. If the test is negative, the control (C) and test (T) line appear. If the test is positive, only the control line (C) appears. If the C and T lines are not visible or the C line is visible, it means that the test is invalid. Each test sample will be read and recorded by two independent observers.	Change in Urine Cotinine Level at 3 and 6 months from baseline
Secondary	The Information Form on Exposure to Secondhand Smoke	The information form created by the researchers consists of 16 items: for each item; right, wrong, I don't know, can choose one of the options. Each item is scored between 0 and 1 according to the answer given. Accordingly, scores ranging from 0-13 for the first section, 0-3 for the second section, and 0-16 for the sum of the information items are taken. An increase in the score is interpreted as good knowledge of SHS and THS. The Kuder Richardson 20 (KR-20) value of all items was found to be 0.84.	Change in knowledge level at 3 and 6 months from baseline
Secondary	Attitude Form on Exposure to Secondhand and Third hand Smoking	There are 8 attitude statements in the Household Attitude Form on Exposure of Children Under Five to Secondhand Smoking. 1 point for positive attitude statements and 0 (zero) points for negative attitude statements. Accordingly, the attitude score for exposure to second-hand smoking can be taken between 0-6, the tobacco attitude score for third-hand exposure 0-2, and the total attitude score to 0-8. A high score indicates a positive attitude.The KR-20 value of the expressions related to second-hand smoking exposure was found to be 0.84, the Kuder Richardson 20 (KR-20) value of the expressions related to the third-hand smoking exposure was found to be 0.53 and the KR-20 value of the total attitude expressions was 0.77.	Change in attitude level at 3 and 6 months from baseline
Secondary	Beliefs About Third-Hand Smoke (THS) Scale	The scale, which consists of nine items, is answered in a 5-point Likert type. The scale was developed in United States in 2017 to determine beliefs about Third-Hand Smoke (THS). The Turkish validity and reliability study of the scale was carried out in 2019. As the score from the scale gets closer to 5, it is interpreted that the individual believes in the effects of THS on the environment and health, and as it approaches 1, the individual does not believe in the effects of THS on the environment and health.	Change in beliefs level at 3 and 6 months from baseline