Early Mother-Baby AttachmentNCT04916301
Early Period Mother-Infant Attachment Indicators
An observational study of Early Mother-Baby Attachment, run by Sakarya University.
Trial summary
The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.This is a cross-sectional, methodological, descriptive, and correlational study.The sample of the study for analysis was planned to consist of 130 mothers..The content… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Mother-Baby Attachment
- What is being tested?
- Early Mother-Infant Attachment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jul 2021
- Phase
- Observational
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 130 volunteer mothers
Who may be able to join
- The inclusion criteria were as follows: the participants had to be over 18 years old, had to have volunteered to participate in the study, had to have no health problems related to the newborn, and had to be the mother or the primary care provider.
Who cannot join
- the participants had not to have volunteered to participate in the study, had to have health problems related to the newborn, and had not to be the mother or the primary care provider.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Developing a Scale for the Psychometric Evaluation of Early Period Mother-Infant Attachment Indicators
The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.This is a cross-sectional, methodological, descriptive, and correlational study.The sample of the study for analysis was planned to consist of 130 mothers..The content validity of the scale will assessed by consulting 13 experts in pediatrics, psychiatry and women's health.After the contents of the scale were verified, a pilot test will conducted with a draft scale consisting of 13 items.After the analyzes to be made, it will be tested whether it is a validite and reliable measurement scale.
Read the detailed description
The behavior of the mother toward her baby in the mother-baby encounter after the birth provides important clues about the bonding process between the mother and the baby in the later period. Therefore, it is important for the nurse responsible for the care of the newborn to carefully observe the mother's behavior to identify the emotional bond between the mother and the baby.Therefore, there is a need for a measurement tool to be developed to be used in the evaluation of early mother-infant attachment, which covers the postnatal period. This scale can enable healthcare professionals to quickly and easily evaluate mother-infant attachment behavior in the early postnatal period. Thus, it can contribute to the early identification of negative attachment behavior that may develop in the future and allow nurses to provide the necessary support. The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.
Design and Method Aim This study aims to develop a tool to measure Early Mother-Infant Attachment Indicators and test them psychometrically.
Study Design This is a cross-sectional, methodological, descriptive, and correlational study.
Methodology The development of The Scale for Evaluating Early Mother-Baby Attachment Indicators, the design of the scale, and the phases in its validity are shown in Figure 1. These items include: (1) the preparation and scoping phase; (2) the development of the questionnaire items and rating scale; (3) the content validity; and (4) the pilot study (psychometric evaluation).
Sample/Participants This study will carried out in the XXXX Training and Research Hospital Maternity Service-Infant Team between june and july of 2021. Participants will selected by the random sampling method. The literature states that the number of samples should be at least five times the number of scale items-ideally 10 times the number of items when developing a scale. The number of items in the scale is 13. Accordingly, the study for analysis was planned to consist of 130 mothers. The inclusion criteria were as follows: the participants had to be over 18 years old, had to have volunteered to participate in the study, had to have no health problems related to the newborn, and had to be the mother or the primary care provider.
Data Collection Tools The Sociodemographic Form This form will completed by the mothers while they were in the hospital. It consists of 26 questions about age, the number of children, the maternal educational level, the income levels of the families, and satisfaction with having a baby.
The Scale for Evaluating Early Mother-Baby Attachment Indicators The scale consists of 13 items showing physical and emotional intimacy, exploration, and striving.The content validity of the scale will assessed by consulting 11 experts in pediatrics, psychiatry and women's health.After the contents of the scale were verified, a pilot test will conducted with a draft scale consisting of 13 items Research experts were sent a draft of the Scale for Evaluating Early Mother-Baby Attachment Indicators and a content validity index (CVI) rating form. They were asked to rate the relevance of each item. Relevance was rated on a three-point scale: 1 = not at all relevant, 2 = need to be fixed, 3 = highly relevant. The experts were also encouraged to add comments to each item and to make suggestions for any other item that they deemed necessary but was missing from the instrument. The CVI rating form was created in congruence with best practices for the development of such forms. Rich reviews from experts provided sufficient data for content review. Based on the analysis of the completed CVI forms and the research experts' comments, two scale items were revised.
- Conditions
- Early Mother-Baby Attachment
- Being tested
- Early Mother-Infant Attachment
- Keywords
- Attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Mother-Infant AttachmentBehavioural
Early Mother-Infant Attachment Indicators will be observed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Early Mother-Infant Attachment Scale.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Mother-Baby AttachmentStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Karakaya Suzan, Sakarya University
- Investigators
- Nursan Cinar, Professor, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916301
- Sponsor's protocol ID
- developing scale
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Scale for the Psychometric Evaluation of Early Period Mother-Infant Attachment Indicators
- ClinicalTrials.gov ID
- NCT04916301
- Acronym / sponsor ID
- developing scale
- Conditions
- Early Mother-Baby Attachment
- Keywords
- Attachment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 7 Jun 2021 (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 purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.This is a cross-sectional, methodological, descriptive, and correlational study.The sample of the study for analysis was planned to consist of 130 mothers..The content validity of the scale will assessed by consulting 13 experts in pediatrics, psychiatry and women's health.After the contents of the scale were verified, a pilot test will conducted with a draft scale consisting of 13 items.After the analyzes to be made, it will be tested whether it is a validite and reliable measurement scale.
Detailed description
The behavior of the mother toward her baby in the mother-baby encounter after the birth provides important clues about the bonding process between the mother and the baby in the later period. Therefore, it is important for the nurse responsible for the care of the newborn to carefully observe the mother's behavior to identify the emotional bond between the mother and the baby.Therefore, there is a need for a measurement tool to be developed to be used in the evaluation of early mother-infant attachment, which covers the postnatal period. This scale can enable healthcare professionals to quickly and easily evaluate mother-infant attachment behavior in the early postnatal period. Thus, it can contribute to the early identification of negative attachment behavior that may develop in the future and allow nurses to provide the necessary support. The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.
Design and Method Aim This study aims to develop a tool to measure Early Mother-Infant Attachment Indicators and test them psychometrically.
Study Design This is a cross-sectional, methodological, descriptive, and correlational study.
Methodology The development of The Scale for Evaluating Early Mother-Baby Attachment Indicators, the design of the scale, and the phases in its validity are shown in Figure 1. These items include: (1) the preparation and scoping phase; (2) the development of the questionnaire items and rating scale; (3) the content validity; and (4) the pilot study (psychometric evaluation).
Sample/Participants This study will carried out in the XXXX Training and Research Hospital Maternity Service-Infant Team between june and july of 2021. Participants will selected by the random sampling method. The literature states that the number of samples should be at least five times the number of scale items-ideally 10 times the number of items when developing a scale. The number of items in the scale is 13. Accordingly, the study for analysis was planned to consist of 130 mothers. The inclusion criteria were as follows: the participants had to be over 18 years old, had to have volunteered to participate in the study, had to have no health problems related to the newborn, and had to be the mother or the primary care provider.
Data Collection Tools The Sociodemographic Form This form will completed by the mothers while they were in the hospital. It consists of 26 questions about age, the number of children, the maternal educational level, the income levels of the families, and satisfaction with having a baby.
The Scale for Evaluating Early Mother-Baby Attachment Indicators The scale consists of 13 items showing physical and emotional intimacy, exploration, and striving.The content validity of the scale will assessed by consulting 11 experts in pediatrics, psychiatry and women's health.After the contents of the scale were verified, a pilot test will conducted with a draft scale consisting of 13 items Research experts were sent a draft of the Scale for Evaluating Early Mother-Baby Attachment Indicators and a content validity index (CVI) rating form. They were asked to rate the relevance of each item. Relevance was rated on a three-point scale: 1 = not at all relevant, 2 = need to be fixed, 3 = highly relevant. The experts were also encouraged to add comments to each item and to make suggestions for any other item that they deemed necessary but was missing from the instrument. The CVI rating form was created in congruence with best practices for the development of such forms. Rich reviews from experts provided sufficient data for content review. Based on the analysis of the completed CVI forms and the research experts' comments, two scale items were revised.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 130 volunteer mothers
Key inclusion criteria (1 listed)
- The inclusion criteria were as follows: the participants had to be over 18 years old, had to have volunteered to participate in the study, had to have no health problems related to the newborn, and had to be the mother or the primary care provider.
Key exclusion criteria (1 listed)
- the participants had not to have volunteered to participate in the study, had to have health problems related to the newborn, and had not to be the mother or the primary care provider.
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 |
|---|---|---|
| Early Mother-Infant AttachmentEarly Mother-Infant Attachment Indicators will be observed. | Behavioural | – |
Primary outcome
The Early Mother-Infant Attachment Scale.
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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.
Nursan Cinar, Professor principal investigator
Sakarya University
Questions about this trial
What is this clinical trial studying?
An observational study of Early Mother-Baby Attachment, run by Sakarya University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact özge Karakaya Suzan, res. asist. (+90 264 295 4341, ozgekarakayasuzan@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Early Mother-Infant Attachment Scale. (time frame: one month). 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 7 Jun 2021.