Sudden Infant Death SyndromeNCT07037914
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
A study testing Education and Counseling and Leaflet in people with Sudden Infant Death Syndrome and Shaken Baby Syndrome, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy levels.The objectives of the study are to ensure that mothers acquire sufficient knowledge and skills regarding SIDS and SBS, and to enhance their self-efficacy levels.The… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death Syndrome, Shaken Baby Syndrome
- What is being tested?
- Education and Counseling and Leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older,
- Having a healthy newborn,
- Having one or more children,
- Having at least a primary school education,
- Having a smartphone and mobile internet access,
- Being able to speak, read, listen, and understand Turkish, able to follow instructions, and having no communication barriers,
- Voluntarily agreeing to participate in the study.
Who cannot join
- Mothers whose newborns have any health problems will be excluded from the study.
- Mothers who wish to withdraw from the study at any point during the research process will be removed from the study.
- did not complete the process of the assessment and intervention of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Amasya University
Amasya, 05000
Dilara Aydın Tozlu, MSc, 05432013779, dilara.aydin@amasya.edu.tr
Emine Efe, Prof
About this study
Official title: The Impact of the Nurse-Led "My Baby is Safe" Educational Program on Mothers' Knowledge, Skills, and Self-Efficacy
The aim of this study is to determine the effect of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy levels.The objectives of the study are to ensure that mothers acquire sufficient knowledge and skills regarding SIDS and SBS, and to enhance their self-efficacy levels.The participants were randomly assigned to one group that received only the My Baby is Safe Educational Program (Group I), or to another group that received standard care (Group II).
Read the detailed description
The aim of this randomized controlled study was to determine the effectiveness of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy related to the prevention of Sudden Infant Death Syndrome (SIDS) and Shaken Baby Syndrome (SBS).
This study, which included postpartum mothers, was conducted at Amasya University between July 2025 and July 2026. Participants were randomly assigned to either the intervention group, which received the My Baby is Safe Educational Program (Group I), or the control group, which received standard care (Group II).
The intervention consisted of a nurse-led, individualized, repetitive educational program that began in the postpartum period and included home visits. The program aimed to inform mothers about risk and protective factors for SIDS and SBS, to encourage the creation and maintenance of a safe sleep environment, and to promote the use of appropriate soothing techniques for crying infants.
The study sample consisted of 50 mothers, with 25 mothers assigned to each group. Data collection instruments included: the Infant and Parent Information Form, Sudden Infant Death Syndrome Awareness Scale - Mother Form, the Sudden Infant Death Syndrome Care Skills Form, the Shaken Baby Syndrome Awareness Assessment Scale-Short Form, the Shaken Baby Syndrome Care Skills Form, the Sleep Environment Checklist, and the Perceived Maternal Parenting Self-Efficacy Scale.
Data were analyzed using the licensed Statistical Package for the Social Sciences (SPSS v.23) software of Akdeniz University. Repeated measures ANOVA was used to evaluate the changes over time between the groups and the interaction effects between group and time. Spearman correlation analysis was performed to assess relationships between variables. The significance level was set at p<0.05. Additionally, effect sizes were calculated.
As a result, it is anticipated that the My Baby is Safe Educational Program will improve mothers' knowledge, skills, and self-efficacy related to the prevention of SIDS and SBS.
- Conditions
- Sudden Infant Death Syndrome, Shaken Baby Syndrome
- Being tested
- Education and Counseling, Leaflet
- Keywords
- Sudden Infant Death Syndrome, Shaken Baby Syndrome, Safe Sleep, Pediatric Nursing, Education
- Medical subject headings
- Sudden Infant Death, Shaken Baby Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and CounselingBehavioural
The researcher will inform the mothers (n=25) that the My Baby is Safe Educational Program will be delivered individually through distance education via Microsoft Teams at times convenient for them, and that the program will be completed over 5 days. The scheduling will ensure that all modules included in the My Baby is Safe Educational Program are completed within one week at the latest. Mothers will be informed that they can receive telephone counseling from the researcher until their infants reach two months of age, and the researcher's phone number will be provided to them. During this period, the researchers will send weekly reminder messages to the mothers' phones, encouraging them to read the provided educational booklet and to watch the educational videos.
The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this home visit, the researcher will assess the infant's sleep environment for safe sleep practices.
LeafletOther
No structured or planned education will be provided to the control group by the researchers during the study period. After the first assessment, the mothers in the control group will receive a brochure prepared by the researchers based on the literature, containing brief informational notes on SIDS and SBS.
The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this visit, the researcher will observe the home environment where the infant resides and evaluate the infant's sleep environment in terms of safe sleep practices.
After data collection from the intervention group has been completed, the same intervention (My Baby is Safe Educational Program) will also be delivered to the mothers in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group I-Education and Counseling | Experimental | Not described Receives: Behavioral: Education and Counseling |
| Control: Group II-Leaflet | Other | Not described Receives: Other: Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden Infant Death Syndrome Awareness
Sudden Infant Death Syndrome Awareness Scale - Mother Form The scale consists of six items, divided into two sub-dimensions. These dimensions are 'Baby's Sleep Area' and 'Baby's Sleep Environment.' The scale uses a five-point Likert scale (Never = 1, Rarely = 2, Sometimes = 3, Often = 4, Always = 5). The last three questions of the scale are reverse-coded. The scale is interpreted based on the total scores of the subscales rather than the total score. As the score obtained from each subscale increases, it is interpreted that the level of awareness is also low. The Cronbach's alpha and McDonald's omega values for the 'Baby's Sleep Area' and 'Baby's Sleep Environment' subscales were found to be above 0.60.
Measured: baseline (first assessment)
Sudden Infant Death Syndrome Awareness
Sudden Infant Death Syndrome Awareness Scale - Mother Form The scale consists of six items, divided into two sub-dimensions. These dimensions are 'Baby's Sleep Area' and 'Baby's Sleep Environment.' The scale uses a five-point Likert scale (Never = 1, Rarely = 2, Sometimes = 3, Often = 4, Always = 5). The last three questions of the scale are reverse-coded. The scale is interpreted based on the total scores of the subscales rather than the total score. As the score obtained from each subscale increases, it is interpreted that the level of awareness is also low. The Cronbach's alpha and McDonald's omega values for the 'Baby's Sleep Area' and 'Baby's Sleep Environment' subscales were found to be above 0.60.
Measured: at the end of the invervention program (8 weeks after from baseline)
Sudden Infant Death Syndrome Care Skills
Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Measured: baseline (first assessment)
Sudden Infant Death Syndrome Care Skills
Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Measured: a home visit on the 15th day postpartum (2 weeks after from baseline)
Sudden Infant Death Syndrome Care Skills
Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Measured: at the end of the invervention program (8 weeks after from baseline)
Shaken Baby Syndrome Awareness
Shaken Baby Syndrome Awareness Assessment Scale - Short Form (SBS-AAS-SF) The scale consists of three dimensions: soothing techniques, discipline techniques, and potential injury. The items in the scale are designed to assess whether the actions of caregivers are appropriate within each of these three dimensions. The scale includes 12 items for each dimension, totaling 36 items, and is formatted as a 6-point Likert scale. The correlations between the scores of the subscales indicate the degree of linearity among the three dimensions. The scale scores provide insight into the interrelationships of the constructs associated with shaking a baby, offering information on how effective interventions should be structured.
Measured: baseline (first assessment)
Shaken Baby Syndrome Awareness
Shaken Baby Syndrome Awareness Assessment Scale - Short Form (SBS-AAS-SF) The scale consists of three dimensions: soothing techniques, discipline techniques, and potential injury. The items in the scale are designed to assess whether the actions of caregivers are appropriate within each of these three dimensions. The scale includes 12 items for each dimension, totaling 36 items, and is formatted as a 6-point Likert scale. The correlations between the scores of the subscales indicate the degree of linearity among the three dimensions. The scale scores provide insight into the interrelationships of the constructs associated with shaking a baby, offering information on how effective interventions should be structured.
Measured: at the end of the invervention program (8 weeks after from baseline)
Shaken Baby Syndrome Care Skills
Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Measured: baseline (first assessment)
Shaken Baby Syndrome Care Skills
Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Measured: a home visit on the 15th day postpartum (2 weeks after from baseline)
Shaken Baby Syndrome Care Skills
Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Measured: at the end of the invervention program (8 weeks after from baseline)
Self-Efficacy
The Perceived Maternal Parenting Self-Efficacy Questionnaire The scale consists of 20 items and 4 subdimensions. It includes 18 positively worded items, rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The scale comprises three subfactors: "mother-infant interaction" (items 1, 2, 4, 5, 6, 7, 8, 13, 18), "caregiving procedures" (items 3, 14, 15, 16, 17), and "belief in the ability to foster positive infant behavior" (items 9, 10, 11, 12). Higher total scores indicate higher levels of maternal self-efficacy. A total score is obtained by summing the scores of all items.
Measured: baseline (first assessment)
Self-Efficacy
The Perceived Maternal Parenting Self-Efficacy Questionnaire The scale consists of 20 items and 4 subdimensions. It includes 18 positively worded items, rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The scale comprises three subfactors: "mother-infant interaction" (items 1, 2, 4, 5, 6, 7, 8, 13, 18), "caregiving procedures" (items 3, 14, 15, 16, 17), and "belief in the ability to foster positive infant behavior" (items 9, 10, 11, 12). Higher total scores indicate higher levels of maternal self-efficacy. A total score is obtained by summing the scores of all items.
Measured: at the end of the invervention program (8 weeks after from baseline)
Secondary outcomes (1)
Sleep Environment
Sleep Environment Checklist The Sleep Environment Checklist was developed by the researchers based on the relevant literature to assess mothers' care skills and compliance with safe sleep practices. The checklist consists of a total of 14 items.
Measured: a home visit on the 15th day postpartum (2 weeks after from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Infant Death SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara AYDIN TOZLU, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037914
- Sponsor's protocol ID
- 13062025
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Nurse-Led "My Baby is Safe" Educational Program on Mothers' Knowledge, Skills, and Self-Efficacy
- ClinicalTrials.gov ID
- NCT07037914
- Acronym / sponsor ID
- 13062025
- Conditions
- Sudden Infant Death Syndrome, Shaken Baby Syndrome
- Keywords
- Sudden Infant Death Syndrome, Shaken Baby Syndrome, Safe Sleep, Pediatric Nursing, Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Jun 2025 (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 study is to determine the effect of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy levels.The objectives of the study are to ensure that mothers acquire sufficient knowledge and skills regarding SIDS and SBS, and to enhance their self-efficacy levels.The participants were randomly assigned to one group that received only the My Baby is Safe Educational Program (Group I), or to another group that received standard care (Group II).
Detailed description
The aim of this randomized controlled study was to determine the effectiveness of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy related to the prevention of Sudden Infant Death Syndrome (SIDS) and Shaken Baby Syndrome (SBS).
This study, which included postpartum mothers, was conducted at Amasya University between July 2025 and July 2026. Participants were randomly assigned to either the intervention group, which received the My Baby is Safe Educational Program (Group I), or the control group, which received standard care (Group II).
The intervention consisted of a nurse-led, individualized, repetitive educational program that began in the postpartum period and included home visits. The program aimed to inform mothers about risk and protective factors for SIDS and SBS, to encourage the creation and maintenance of a safe sleep environment, and to promote the use of appropriate soothing techniques for crying infants.
The study sample consisted of 50 mothers, with 25 mothers assigned to each group. Data collection instruments included: the Infant and Parent Information Form, Sudden Infant Death Syndrome Awareness Scale - Mother Form, the Sudden Infant Death Syndrome Care Skills Form, the Shaken Baby Syndrome Awareness Assessment Scale-Short Form, the Shaken Baby Syndrome Care Skills Form, the Sleep Environment Checklist, and the Perceived Maternal Parenting Self-Efficacy Scale.
Data were analyzed using the licensed Statistical Package for the Social Sciences (SPSS v.23) software of Akdeniz University. Repeated measures ANOVA was used to evaluate the changes over time between the groups and the interaction effects between group and time. Spearman correlation analysis was performed to assess relationships between variables. The significance level was set at p<0.05. Additionally, effect sizes were calculated.
As a result, it is anticipated that the My Baby is Safe Educational Program will improve mothers' knowledge, skills, and self-efficacy related to the prevention of SIDS and SBS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group I-Education and Counseling | Experimental | Behavioral: Education and Counseling |
| Control: Group II-Leaflet | Other | Other: Leaflet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older,
- Having a healthy newborn,
- Having one or more children,
- Having at least a primary school education,
- Having a smartphone and mobile internet access,
Key exclusion criteria (3 listed)
- Mothers whose newborns have any health problems will be excluded from the study.
- Mothers who wish to withdraw from the study at any point during the research process will be removed from the study.
- did not complete the process of the assessment and intervention of this study.
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 |
|---|---|---|
| Education and CounselingThe researcher will inform the mothers (n=25) that the My Baby is Safe Educational Program will be delivered individually through distance education via Microsoft Teams at times convenient for them, and that the program will be completed over 5 days. The scheduling will ensure that all modules included in the My Baby is Safe Educational Program are completed within one week at the latest. Mothers will be informed that they can receive telephone counseling from the researcher until their infants reach two months of age, and the researcher's phone number will be provided to them. During this period, the researchers will send weekly reminder messages to the mothers' phones, encouraging them to read the provided educational booklet and to watch the educational videos. The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this home visit, the researcher will assess the infant's sleep environment for safe sleep practices. | Behavioural | Experimental: Group I-Education and Counseling |
| LeafletNo structured or planned education will be provided to the control group by the researchers during the study period. After the first assessment, the mothers in the control group will receive a brochure prepared by the researchers based on the literature, containing brief informational notes on SIDS and SBS. The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this visit, the researcher will observe the home environment where the infant resides and evaluate the infant's sleep environment in terms of safe sleep practices. After data collection from the intervention group has been completed, the same intervention (My Baby is Safe Educational Program) will also be delivered to the mothers in the control group. | Other | Control: Group II-Leaflet |
Primary outcome
Sudden Infant Death Syndrome Awareness
Time frame: baseline (first assessment)
Sudden Infant Death Syndrome Awareness Scale - Mother Form The scale consists of six items, divided into two sub-dimensions. These dimensions are 'Baby's Sleep Area' and 'Baby's Sleep Environment.' The scale uses a five-point Likert scale (Never = 1, Rarely = 2, Sometimes = 3, Often = 4, Always = 5). The last three questions of the scale are reverse-coded. The scale is interpreted based on the total scores of the subscales rather than the total score. As the score obtained from each subscale increases, it is interpreted that the level of awareness is also low. The Cronbach's alpha and McDonald's omega values for the 'Baby's Sleep Area' and 'Baby's Sleep Environment' subscales were found to be above 0.60.
Sudden Infant Death Syndrome Awareness
Time frame: at the end of the invervention program (8 weeks after from baseline)
Sudden Infant Death Syndrome Awareness Scale - Mother Form The scale consists of six items, divided into two sub-dimensions. These dimensions are 'Baby's Sleep Area' and 'Baby's Sleep Environment.' The scale uses a five-point Likert scale (Never = 1, Rarely = 2, Sometimes = 3, Often = 4, Always = 5). The last three questions of the scale are reverse-coded. The scale is interpreted based on the total scores of the subscales rather than the total score. As the score obtained from each subscale increases, it is interpreted that the level of awareness is also low. The Cronbach's alpha and McDonald's omega values for the 'Baby's Sleep Area' and 'Baby's Sleep Environment' subscales were found to be above 0.60.
Sudden Infant Death Syndrome Care Skills
Time frame: baseline (first assessment)
Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Sudden Infant Death Syndrome Care Skills
Time frame: a home visit on the 15th day postpartum (2 weeks after from baseline)
Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Sudden Infant Death Syndrome Care Skills
Time frame: at the end of the invervention program (8 weeks after from baseline)
Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Shaken Baby Syndrome Awareness
Time frame: baseline (first assessment)
Shaken Baby Syndrome Awareness Assessment Scale - Short Form (SBS-AAS-SF) The scale consists of three dimensions: soothing techniques, discipline techniques, and potential injury. The items in the scale are designed to assess whether the actions of caregivers are appropriate within each of these three dimensions. The scale includes 12 items for each dimension, totaling 36 items, and is formatted as a 6-point Likert scale. The correlations between the scores of the subscales indicate the degree of linearity among the three dimensions. The scale scores provide insight into the interrelationships of the constructs associated with shaking a baby, offering information on how effective interventions should be structured.
Shaken Baby Syndrome Awareness
Time frame: at the end of the invervention program (8 weeks after from baseline)
Shaken Baby Syndrome Awareness Assessment Scale - Short Form (SBS-AAS-SF) The scale consists of three dimensions: soothing techniques, discipline techniques, and potential injury. The items in the scale are designed to assess whether the actions of caregivers are appropriate within each of these three dimensions. The scale includes 12 items for each dimension, totaling 36 items, and is formatted as a 6-point Likert scale. The correlations between the scores of the subscales indicate the degree of linearity among the three dimensions. The scale scores provide insight into the interrelationships of the constructs associated with shaking a baby, offering information on how effective interventions should be structured.
Shaken Baby Syndrome Care Skills
Time frame: baseline (first assessment)
Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Shaken Baby Syndrome Care Skills
Time frame: a home visit on the 15th day postpartum (2 weeks after from baseline)
Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Shaken Baby Syndrome Care Skills
Time frame: at the end of the invervention program (8 weeks after from baseline)
Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Self-Efficacy
Time frame: baseline (first assessment)
The Perceived Maternal Parenting Self-Efficacy Questionnaire The scale consists of 20 items and 4 subdimensions. It includes 18 positively worded items, rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The scale comprises three subfactors: "mother-infant interaction" (items 1, 2, 4, 5, 6, 7, 8, 13, 18), "caregiving procedures" (items 3, 14, 15, 16, 17), and "belief in the ability to foster positive infant behavior" (items 9, 10, 11, 12). Higher total scores indicate higher levels of maternal self-efficacy. A total score is obtained by summing the scores of all items.
Self-Efficacy
Time frame: at the end of the invervention program (8 weeks after from baseline)
The Perceived Maternal Parenting Self-Efficacy Questionnaire The scale consists of 20 items and 4 subdimensions. It includes 18 positively worded items, rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The scale comprises three subfactors: "mother-infant interaction" (items 1, 2, 4, 5, 6, 7, 8, 13, 18), "caregiving procedures" (items 3, 14, 15, 16, 17), and "belief in the ability to foster positive infant behavior" (items 9, 10, 11, 12). Higher total scores indicate higher levels of maternal self-efficacy. A total score is obtained by summing the scores of all items.
1 secondary outcome
Sleep Environment
Time frame: a home visit on the 15th day postpartum (2 weeks after from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Yes. Data will be shared on reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Counseling and Leaflet in people with Sudden Infant Death Syndrome and Shaken Baby Syndrome, run by Amasya 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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilara Aydın Tozlu, MSc (05432013779, dilara.aydin@amasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden Infant Death Syndrome Awareness (time frame: baseline (first assessment)). The study lists 12 primary outcomes in all. 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 26 Jun 2025.