Mental DisabilityNCT06633549
The Effect of Home Accidents Prevention Training Given to Mothers of Mentally Disabled Children
A study testing Home Accidents Prevention Training in people with Mental Disability and Mothers, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disability, Mothers, Home Injury
- What is being tested?
- Home Accidents Prevention Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Home Accidents Prevention Training Given to Mothers of Mentally Disabled Children Aged 0-6: A Randomized Controlled Trial
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.
Read the detailed description
This study was conducted to examine the effects of education on home accidents given to mothers of mentally disabled children aged 0-6. The sample of the study consisted of 83 mothers of mentally disabled children aged 0-6 registered in four special education centers in Kocaeli province between May 2023 and June 2024 (education group: 40 mothers; control group: 43 mothers). Research data were collected using the Information Form and the Scale for Diagnosing Mothers' Safety Precautions for Home Accidents in 0-6 Year Old Children. The mothers in the education and control groups were informed about the study, their written consent was obtained, and they were asked to fill out information forms. The mothers in the education group were given a single, 45-minute face-to-face education on preventing home accidents. The Mothers' Safety Measures for Home Accidents in Children aged 0-6 were administered the Scale before and one month after the training. The mothers in the control group did not receive any training; the Scale for Identifying Mothers' Safety Precautions for Home Accidents in Children Aged 0-6 was administered during the first interview and again one month later.
- Conditions
- Mental Disability, Mothers, Home Injury
- Being tested
- Home Accidents Prevention Training, Control Group
- Keywords
- home accidents, child, mother, risk factors, mental disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Accidents Prevention TrainingOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Educated | Experimental | Educated Group Receives: Other: Home Accidents Prevention Training |
| Uneducated | Other | Uneducated Group (Control) Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the training and one month after the training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 May 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Erkut, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633549
- Sponsor's protocol ID
- 2022/21-07
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Home Accidents Prevention Training Given to Mothers of Mentally Disabled Children Aged 0-6: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06633549
- Acronym / sponsor ID
- 2022/21-07
- Conditions
- Mental Disability, Mothers, Home Injury
- Keywords
- home accidents, child, mother, risk factors, mental disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Oct 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.
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.
Detailed description
This study was conducted to examine the effects of education on home accidents given to mothers of mentally disabled children aged 0-6. The sample of the study consisted of 83 mothers of mentally disabled children aged 0-6 registered in four special education centers in Kocaeli province between May 2023 and June 2024 (education group: 40 mothers; control group: 43 mothers). Research data were collected using the Information Form and the Scale for Diagnosing Mothers' Safety Precautions for Home Accidents in 0-6 Year Old Children. The mothers in the education and control groups were informed about the study, their written consent was obtained, and they were asked to fill out information forms. The mothers in the education group were given a single, 45-minute face-to-face education on preventing home accidents. The Mothers' Safety Measures for Home Accidents in Children aged 0-6 were administered the Scale before and one month after the training. The mothers in the control group did not receive any training; the Scale for Identifying Mothers' Safety Precautions for Home Accidents in Children Aged 0-6 was administered during the first interview and again one month later.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educated | Experimental | Other: Home Accidents Prevention TrainingEducated Group |
| Uneducated | Other | Other: Control GroupUneducated Group (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Accidents Prevention TrainingMothers 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. | Other | Educated |
| Control GroupMothers 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. | Other | Uneducated |
Primary outcome
The Scale for Diagnosing the Safety Measures of the Mother for Household Accidents in Children Aged 0-6
Time frame: Before the training and one month after the training.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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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. This study is not recruiting at the moment.
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?
A study testing Home Accidents Prevention Training in people with Mental Disability and Mothers, run by Maltepe 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Scale for Diagnosing the Safety Measures of the Mother for Household Accidents in Children Aged 0-6 (time frame: Before the training and one month after the training.). 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 16 Oct 2024.