NCT06633549

Brief Summary

The aim of this research is to examine the effect of education for home accidents given to mothers with mentally disabled children in the age group of 0-6.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 7, 2024

Last Update Submit

October 13, 2024

Conditions

Keywords

home accidentschildmotherrisk factorsmental disability

Outcome Measures

Primary Outcomes (1)

  • The Scale for Diagnosing the Safety Measures of the Mother for Household Accidents in Children Aged 0-6

    The scale developed by Çınar and colleagues evaluates the safety precautions taken by mothers of children aged 0-6 to protect their children from home accidents (burns, falls, poisoning, sharp-edged injuries, foreign object aspiration, drowning, electric shocks). The Scale for Identifying Mothers' Safety Precautions for Home Accidents in Children Aged 0-6 consists of a total of 40 items, with 34 positive and 6 negative statements. Each item is scored between 1-5 on the five-point Likert-type scale. While the items containing positive statements always receive 5 points, often 4 points, sometimes 3 points, rarely 2 points, and never 1 point, the items containing negative statements receive 6, 9, 23, 26, 30, and 40 never 5 points, rarely 4 points, sometimes 3 points, often 2 points, and always 1 point. The minimum score of the scale is 40 and the maximum score is 200. The Croncbach alpha internal consistency coefficient value is 0.82.

    Before the training and one month after the training.

Study Arms (2)

Educated

EXPERIMENTAL

Educated Group

Other: Home Accidents Prevention Training

Uneducated

OTHER

Uneducated Group (Control)

Other: Control Group

Interventions

Mothers in the education group who participated in the study were informed about the research and their written consent was obtained. Mothers filled out the 'Information Form' then completed the 'Diagnostic Scale of the Mother's Safety Measures for Home Accidents in Children Aged 0-6 Years'. Mothers were helped when filling out the form and their questions were answered. The training program was organized so that there would be a maximum of 5 mothers in each group. The trainings were conducted face-to-face with a PowerPoint presentation and lasted about 40-45 minutes. Question-answer and discussion methods were used during the training. After the training, the mothers were asked to fill out the same scale again one month later. One month after the training, the mothers were interviewed face-to-face and the scale was filled in again and the changes they made at home were recorded.

Educated

Mothers in the control group were informed about the research and the 'Informed Consent Form' was signed. The mothers filled out the 'Information Form' and this process took about 15-20 minutes. Mothers were helped when filling out the form and their questions were answered. In addition, mothers were asked to complete the 'Diagnostic Scale of the Mother's Safety Measures for Home Accidents in Children Aged 0-6' by introducing. A month later, they were informed that they had to fill out this scale again. A month later, the mothers were interviewed face-to-face and allowed to fill out the scale again. After the last test, the mothers in the control group were given 'Home Accidents and Prevention Training for Children in the 0-6 Age Group' and the output of the training presentation was distributed.

Uneducated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers with mentally disabled children aged 0-6
  • Mothers who agree to participate in the research
  • Mothers who agree to be contacted after 1 month for the post-test
  • Mothers who know and speak Turkish at the native level

You may not qualify if:

  • Mothers with mentally disabled children over the age of 6
  • Mothers who do not agree to participate in the study
  • Mothers who do not agree to be contacted after 1 month for the post-test
  • Mothers with mental disabilities
  • Mothers who do not know or speak Turkish at the native level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 9, 2024

Study Start

May 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations