NCT06691022

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 11, 2024

Last Update Submit

November 13, 2024

Conditions

Smoking BehaviorSpecial Needs Child

Keywords

smokingChild's Challenging Behaviourparentsstres

Outcome Measures

Primary Outcomes (4)

  • The Child's Challenging Behaviour Scale 2 (CCBS-2)

    face to face

    1 years

  • parent stress scaleparent stress scale parent stress scale Parent's Stress Scale

    Face to face

    1 years

  • cotinin in urine

    urine analysis

    1 years

  • sociodemographic questionnaire

    face to face

    1 years

Study Arms (1)

smoking

not smoking

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

special needs child

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TURKEY

Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 15, 2024

Study Start

November 23, 2023

Primary Completion

April 1, 2024

Study Completion

September 1, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

to be specific

Locations

TU(1)