Mother-Infant InteractionNCT06421662
The Role of Attachment Training in Mother-infant Attachment
A study testing Attachment Training in people with Mother-Infant Interaction and Infant Development, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Mother-Infant Interaction, Infant Development, Maternal Behavior
- What is being tested?
- Attachment Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 4 Mar 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old with a primiparous pregnancy,
- 28 to 38 weeks of gestation,
- At least primary school graduate,
- Who can use the internet actively and can receive planned training online,
- Can speak and understand Turkish like a native speaker,
- Expectant mothers who voluntarily accepted the study.
Who cannot join
- Transferring the pregnant woman to another hospital for follow-up and treatment
- Those who cannot use active internet and will not be able to receive online education
- Not completing the post-test after the training
- Not completing the postpartum maternal attachment scale
- Expectant mothers receiving psychiatric treatment
- Those with risky pregnancies
Show all 9Show fewer
- Any congenital anomaly in the baby
- Unwanted baby status
- Withdrawal of the candidate from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Attachment Training Given to Pregnant Women on Mother Infant Attachment
The study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Pregnant women in the study group were given attachment training for 15 days and the effect of the training on mother-infant attachment was investigated by using the mother-infant attachment scale at postpartum week 8 in comparison with the control group.
Read the detailed description
Pregnant women between 28th and 38th weeks of gestational age who applied to an outpatient clinic of a training and research hospital were randomized into two groups. The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was applied as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory" developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. Maternal Attachment Inventory, Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104
- Being tested
- Attachment Training
- Keywords
- infant, maternal attachment, attachment training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment TrainingBehavioural
The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was used as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory " developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Thirty pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the study group. During the training, 7 participants were excluded due to premature birth. Receives: Behavioral: Attachment Training |
| Control Group | No intervention | Thirty-one pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the control group. The control group was administered only the "Maternal Attachment Inventory " developed by Mary Muller in 1994 and the Turkish validity and reliability study was conducted by Şirin and Kavlak at the 8th week after birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attachment
Maternal Attachment Inventory (MAI) Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Aug 2023
- Primary completion1 Jan 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-Infant InteractionStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜVEN BEKTEMUR, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421662
- Sponsor's protocol ID
- mother-infant attachment
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 21 May 2024
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Attachment Training Given to Pregnant Women on Mother Infant Attachment
- ClinicalTrials.gov ID
- NCT06421662
- Acronym / sponsor ID
- mother-infant attachment
- Keywords
- infant, maternal attachment, attachment training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 20 May 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 study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Pregnant women in the study group were given attachment training for 15 days and the effect of the training on mother-infant attachment was investigated by using the mother-infant attachment scale at postpartum week 8 in comparison with the control group.
Detailed description
Pregnant women between 28th and 38th weeks of gestational age who applied to an outpatient clinic of a training and research hospital were randomized into two groups. The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was applied as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory" developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. Maternal Attachment Inventory, Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Attachment TrainingThirty pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the study group. During the training, 7 participants were excluded due to premature birth. |
| Control Group | No intervention | –Thirty-one pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the control group. The control group was administered only the "Maternal Attachment Inventory " developed by Mary Muller in 1994 and the Turkish validity and reliability study was conducted by Şirin and Kavlak at the 8th week after birth. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-40 years old with a primiparous pregnancy,
- 28 to 38 weeks of gestation,
- At least primary school graduate,
- Who can use the internet actively and can receive planned training online,
- Can speak and understand Turkish like a native speaker,
Key exclusion criteria (9 listed)
- Transferring the pregnant woman to another hospital for follow-up and treatment
- Those who cannot use active internet and will not be able to receive online education
- Not completing the post-test after the training
- Not completing the postpartum maternal attachment scale
- Expectant mothers receiving psychiatric treatment
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 TrainingThe study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was used as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory " developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. | Behavioural | Study Group |
Primary outcome
Maternal Attachment
Time frame: 10 minutes
Maternal Attachment Inventory (MAI) Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104.
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 21 May 2024.
- Individual participant dataSharing planned: No
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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 Attachment Training in people with Mother-Infant Interaction and Infant Development, run by Saglik Bilimleri Universitesi 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 6 inclusion and 9 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 21 May 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?
Maternal Attachment (time frame: 10 minutes). 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 21 May 2024.