Attachment DisorderNCT05676996
Investigation of the Effect of Attachment-Based Support Given in the Perinatal Period
A study testing attachment-based support in people with Attachment Disorder, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
It is important that effective intervention programs are developed and implemented in our country by identifying risk factors in the early period. In this aspect, the work is unique. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attachment Disorder
- What is being tested?
- attachment-based support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 28 Feb 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 19 years or older 21 and 26. Primigravida at gestational week Having had a normal delivery Watching all the videos within the scope of Attachment-Based Support Program by the pregnant women in the intervention group Being literate Pregnancy with only one baby The baby is at term Being the mother of the primary caregiver Volunteering to participate in the research The absence of any health problems of the mother and the baby Absence of a physician-diagnosed psychiatric disease in the mother Having a smart phone and wireless internet Pregnant women who answered "No" to Question 34 on the Pregnant Introductory Information Form and did not get a full score from the "Maternal Antenatal Attachment Scale"
Who cannot join
- The development of a situation that prevents the mother from participating in education during pregnancy
- Unwillingness to continue working
- A situation that prevents the mother and baby from staying in the same room in the postpartum period
- Severe trauma or loss of the mother during pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Adapazarı, Sakarya, 54050
About this study
Official title: Investigation of the Effect of Attachment-Based Support Given in the Perinatal Period on Prenatal Bonding, Early Mother-Infant Bonding Indicators and Maternal Bonding
It is important that effective intervention programs are developed and implemented in our country by identifying risk factors in the early period. In this aspect, the work is unique. Unlike the studies in the literature, it is a unique study in terms of determining the risky population that needs to be questioned and strengthened during the prenatal attachment of expectant mothers during pregnancy, and creating a program where mothers can receive uninterrupted support for 24 hours.
Read the detailed description
Mother-infant attachment is also an important factor for adaptation to the maternal role. Attachment begins in the prenatal period and continues in the postnatal period. Attachment in the prenatal and postnatal period is related to each other . Abasi et al. (2013) stated that the attachment strengthening intervention program applied to pregnant women can positively affect maternal mental health, fetal health and ultimately child health. In the study of Akbarzadeh et al. (2016), investigators found that by educating mothers on attachment skills, the bond between mothers and fetuses is strengthened and the mental health of babies can be improved after birth. It has been reported that prenatal attachment affects postnatal parenting roles and plays an important role in the child's growth and development. Therefore, mother-infant attachment begins in the prenatal period, not in the neonatal period. Peppers and Knapp in their study; investigators found that the mother's contact with her stillborn baby did not affect the mother's grief process and suggested that mother-infant attachment begins in the prenatal period, not in the newborn period. Prenatal attachment can be affected by many factors. In the studies carried out; It has been observed that education level, desired pregnancy status, gestational week, feeling fetal movements, coping styles with stress and anxiety experienced during pregnancy, body image perceptions, emotional intelligence and social support perceptions of pregnant women, and the support given to the mother before birth affect prenatal attachment. For this reason, it is important to determine prenatal attachment behaviors during pregnancy, to examine the factors affecting attachment behaviors, to identify pregnant women with low attachment levels, as they may have positive contributions to mother-infant health in the prenatal and postnatal period. When investigators examine the international literature, although there are studies to support attachment, there is a study in our country for the population that can be strengthened by determining the prenatal attachment level. It is important that effective intervention programs are developed and implemented in our country by identifying risk factors in the early period. In this aspect, the work is unique. Unlike the studies in the literature, it is a unique study in terms of determining the risky population that needs to be questioned and strengthened during the prenatal attachment of expectant mothers during pregnancy, and creating a program where mothers can receive uninterrupted support for 24 hours.
- Conditions
- Attachment Disorder
- Being tested
- attachment-based support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attachment-based supportOther
attachment-based support application; It includes video-based trainings on attachment via mobile application and breastfeeding and skin-to-skin contact support for mothers on postpartum day 0.
| Study group | Role | What they receive |
|---|---|---|
| attachment-based support group | Experimental | In addition to the routine follow-ups and trainings that the pregnant women in the intervention group can receive from the hospital, they will be included in the "Attachment Based Support Program". Within the scope of the 1st stage of this support; A mobile application. There are 12 videos on connecting in the mobile application. These videos were shot by the researcher in a professional studio. 22nd-26th of pregnancy. The participants included in the study during the weeks of participation installed this mobile application on their phones during participation. It was requested to complete watching the videos by 36 weeks. In the second phase of Attachment-Based Support, breastfeeding and skin-to-skin contact support are provided to mothers on postpartum day 0. Receives: Other: attachment-based support |
| routine follow-up control group | No intervention | The control group pregnants were left to the routine follow-up of the hospitals during their pregnancy and postpartum period. In this follow-up; When pregnant women apply to the outpatient clinic services of the hospital, appointments are made for their monthly routine follow-up. Information and practices that support mother-infant attachment in attachment-based support modules are not included in these trainings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.
prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score from the scale indicates a high degree of attachment.
Measured: 22.-26. pre-test between weeks
Pregnant women who participated in the Attachment-Based Support Program during the perinatal period showed more early mother-infant attachment symptoms than those who did not.
The scale of early mother-infant attachment indicators is an observational scale consisting of 13 items. The lowest 0 and the highest 26 points are taken from the scale. As the scores obtained from the scale increase, attachment increases.
Measured: this scale will be administered to mothers on postpartum day 0.
Pregnant women who participated in Attachment-Based Support Program in the perinatal period had higher maternal attachment than those who did not.
The maternal attachment scale is a scale applied at the earliest postpartum 1st month. The lowest score to be obtained from the scale varies between 26 and the highest score between 104. A high score from the scale indicates a high level of maternal attachment.
Measured: postpartum 1st month
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.
prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score from the scale indicates a high degree of attachment.
Measured: post-test at 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jun 2021
- Primary completion30 Nov 2022
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attachment DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Karakaya Suzan, Sakarya University
- Investigators
- Nursan CİNAR, PhD, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676996
- Sponsor's protocol ID
- Attachment-Based Support
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2022
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: can be published after the work is completed.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Attachment-Based Support Given in the Perinatal Period on Prenatal Bonding, Early Mother-Infant Bonding Indicators and Maternal Bonding
- ClinicalTrials.gov ID
- NCT05676996
- Acronym / sponsor ID
- Attachment-Based Support
- Conditions
- Attachment Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 9 Jan 2023 (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.
It is important that effective intervention programs are developed and implemented in our country by identifying risk factors in the early period. In this aspect, the work is unique. Unlike the studies in the literature, it is a unique study in terms of determining the risky population that needs to be questioned and strengthened during the prenatal attachment of expectant mothers during pregnancy, and creating a program where mothers can receive uninterrupted support for 24 hours.
Detailed description
Mother-infant attachment is also an important factor for adaptation to the maternal role. Attachment begins in the prenatal period and continues in the postnatal period. Attachment in the prenatal and postnatal period is related to each other . Abasi et al. (2013) stated that the attachment strengthening intervention program applied to pregnant women can positively affect maternal mental health, fetal health and ultimately child health. In the study of Akbarzadeh et al. (2016), investigators found that by educating mothers on attachment skills, the bond between mothers and fetuses is strengthened and the mental health of babies can be improved after birth. It has been reported that prenatal attachment affects postnatal parenting roles and plays an important role in the child's growth and development. Therefore, mother-infant attachment begins in the prenatal period, not in the neonatal period. Peppers and Knapp in their study; investigators found that the mother's contact with her stillborn baby did not affect the mother's grief process and suggested that mother-infant attachment begins in the prenatal period, not in the newborn period. Prenatal attachment can be affected by many factors. In the studies carried out; It has been observed that education level, desired pregnancy status, gestational week, feeling fetal movements, coping styles with stress and anxiety experienced during pregnancy, body image perceptions, emotional intelligence and social support perceptions of pregnant women, and the support given to the mother before birth affect prenatal attachment. For this reason, it is important to determine prenatal attachment behaviors during pregnancy, to examine the factors affecting attachment behaviors, to identify pregnant women with low attachment levels, as they may have positive contributions to mother-infant health in the prenatal and postnatal period. When investigators examine the international literature, although there are studies to support attachment, there is a study in our country for the population that can be strengthened by determining the prenatal attachment level. It is important that effective intervention programs are developed and implemented in our country by identifying risk factors in the early period. In this aspect, the work is unique. Unlike the studies in the literature, it is a unique study in terms of determining the risky population that needs to be questioned and strengthened during the prenatal attachment of expectant mothers during pregnancy, and creating a program where mothers can receive uninterrupted support for 24 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| attachment-based support group | Experimental | Other: attachment-based supportIn addition to the routine follow-ups and trainings that the pregnant women in the intervention group can receive from the hospital, they will be included in the "Attachment Based Support Program". Within the scope of the 1st stage of this support; A mobile application. There are 12 videos on connecting in the mobile application. These videos were shot by the researcher in a professional studio. 22nd-26th of pregnancy. The participants included in the study during the weeks of participation installed this mobile application on their phones during participation. It was requested to complete watching the videos by 36 weeks. In the second phase of Attachment-Based Support, breastfeeding and skin-to-skin contact support are provided to mothers on postpartum day 0. |
| routine follow-up control group | No intervention | –The control group pregnants were left to the routine follow-up of the hospitals during their pregnancy and postpartum period. In this follow-up; When pregnant women apply to the outpatient clinic services of the hospital, appointments are made for their monthly routine follow-up. Information and practices that support mother-infant attachment in attachment-based support modules are not included in these trainings. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- be 19 years or older 21 and 26. Primigravida at gestational week Having had a normal delivery Watching all the videos within the scope of Attachment-Based Support Program by the pregnant women in the intervention group Being literate Pregnancy with only one baby The baby is at term Being the mother of the primary caregiver Volunteering to participate in the research The absence of any health problems of the mother and the baby Absence of a physician-diagnosed psychiatric disease in the mother Having a smart phone and wireless internet Pregnant women who answered "No" to Question 34 on the Pregnant Introductory Information Form and did not get a full score from the "Maternal Antenatal Attachment Scale"
Key exclusion criteria (4 listed)
- The development of a situation that prevents the mother from participating in education during pregnancy
- Unwillingness to continue working
- A situation that prevents the mother and baby from staying in the same room in the postpartum period
- Severe trauma or loss of the mother during pregnancy
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 |
|---|---|---|
| attachment-based supportattachment-based support application; It includes video-based trainings on attachment via mobile application and breastfeeding and skin-to-skin contact support for mothers on postpartum day 0. | Other | attachment-based support group |
Primary outcome
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.
Time frame: 22.-26. pre-test between weeks
prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score from the scale indicates a high degree of attachment.
Pregnant women who participated in the Attachment-Based Support Program during the perinatal period showed more early mother-infant attachment symptoms than those who did not.
Time frame: this scale will be administered to mothers on postpartum day 0.
The scale of early mother-infant attachment indicators is an observational scale consisting of 13 items. The lowest 0 and the highest 26 points are taken from the scale. As the scores obtained from the scale increase, attachment increases.
Pregnant women who participated in Attachment-Based Support Program in the perinatal period had higher maternal attachment than those who did not.
Time frame: postpartum 1st month
The maternal attachment scale is a scale applied at the earliest postpartum 1st month. The lowest score to be obtained from the scale varies between 26 and the highest score between 104. A high score from the scale indicates a high level of maternal attachment.
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.
Time frame: post-test at 36 weeks
prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score from the scale indicates a high degree of attachment.
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 2 Dec 2024.
- Individual participant dataSharing planned: Undecided. can be published after the work is completed.
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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.
Nursan CİNAR, PhD study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attachment-based support in people with Attachment Disorder, run by Sakarya 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 1 inclusion and 4 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 2 Dec 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?
Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher. (time frame: 22.-26. pre-test between weeks). The study lists 4 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 2 Dec 2024.