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ParentingNCT05744531

Internet Based Parenting Education and Information -Motivation-Behavioral Skills (IMB) Model

A study testing Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) Model in people with Parenting and Maternal-Fetal Relations, run by Semra TUNCAY YILMAZ at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, it was aimed to evaluation of the effect of internet-based parenting education based on the information -motivation-behavioral skills (ımb) model on maternal and paternal attachment. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2021to 1 Dec 2021
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Selection criteria for pregnant women
  • Those between the ages of 18 - 35,
  • At least primary school graduate,
  • First pregnancy and 28 th- 30th gestational week,
  • Not having a chronic health problem before pregnancy (diabetes mellitus, hypertension, kidney failure, liver failure, epilepsy, etc.),
  • Those who do not have a risky pregnancy (gestational diabetes, preeclampsia, multiple pregnancy, etc.) and continue their antenatal follow-up,
Show all 21Show fewer
  • No diagnosed psychiatric problem (Anxiety, anxiety disorder, depression, bipolar etc.),
  • Speaking Turkish and not having any communication barriers,
  • Not a member of health sciences,
  • Those who have not participated in parenting education before,
  • Having a healthy spouse/partner,
  • Having access to the Internet, computer and smart phone,
  • Selection criteria for fathers
  • Those between the ages of 18 - 35,
  • At least primary school graduate,
  • No diagnosed psychiatric problem (Anxiety, anxiety disorder, depression, bipolar etc.),
  • Speaking Turkish and not having any communication barriers,
  • Not a member of health sciences,
  • Those who have not participated in parenting education before,
  • Having a healthy spouse/partner,
  • Having access to the Internet, computer and smart phone,

Who cannot join

  • Inclusion of the mother in the risky pregnancies group (bleeding, preeclampsia, premature birth, etc.),
  • Taking the newborn to the intensive care unit,
  • Incomplete filling of data collection forms,
  • If one or any of the parents has stopped participating in the study; both individuals will be excluded from the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Internet-based Parenting Education Based on the Information -Motivation-Behavioral Skills (IMB) Model on Maternal and Paternal Attachment

In this study, it was aimed to evaluation of the effect of internet-based parenting education based on the information -motivation-behavioral skills (ımb) model on maternal and paternal attachment.

Read the detailed description

Healthy pregnant women and their spouses participated in this study. Pregnant women and their spouses who met the research criteria were identified and randomized as intervention and control groups according to the order of application to antenatal clinic.

This study was carried out in two stages. In the first stage of the study pregnant women in both groups filled in the İndividual İnformation Form/ Mother and Prental Attachment İnventory. Spouses in both groups filled in the İndividual İnformation Form/ Father and Intrauterine Father Attachment Scale. A guide to providing access to internet-based education, training booklet and attachment diary was given to the pregnant women and their spouses in the intervention group. A guide to providing access to internet-based education, training booklet and attachment diary was not given to the pregnant women and their spouses in the control group.

In the second phase of the study; Internet-based Parenting education based on the Information-Motivation-Behavioral Skills (IMB) Model was given to the pregnant women and their spouses in the intervention group, once a week between 31 and 34 weeks of gestation, for a total of 4 times. No training was given to the pregnant women and their spouses in the control group. Prental Attachment Inventory was applied online to the pregnant women in both groups at 35th gestational week. The intrauterine Father Attachment Scale was applied online to the spouses in both groups at the 35th gestational week. Internet-based counseling was given to the pregnant women and their spouses in the intervention group as part of the motivation step of the model. This counseling was applied twice, the first between 36 and 38 weeks of gestation and the second between 20 and 40 days after delivery. Counseling was not provided to the pregnant women and their spouses in the control group. Within the scope of the behavioral skills step of the model, Maternal Attachment Inventory was applied to the mothers in the intervention group, and Paternal Infant Attachment Scale was applied to the fathers in the intervention group online at the 3nd month postpartum. The Mother Attachment Inventory was administered online to the mothers in the control group, and the Paternal Infant Attachment Scale was administered online to the fathers in the control group in the thirth month after birth.

Parameters to Look for:

In this study, it is aimed to Evaluate the Effect of Internet-based Parenting Education based on the Information-Motivation-Behavioral Skills (IMB) Model on Maternal and Paternal Attachment. Within the scope of the study, Prental Attachment İnventory scores of the pregnant women in the intervention and control groups were compared before and after the education. In addition, Maternal Attachment Inventory scores of mothers in the intervention and control groups in the postpartum period were compared. The intrauterine Father Attachment Scale scores of the fathes in the intervention and control groups were compared before and after the education. Paternal Infant Attachment Scale score in the 3nd month after birth were compared between fathers in the intervention and control groups.

Population of the Study Group:

The population of the study consisted of primiparous pregnant women and their spouses who applied to Ankara City Hospital Gynecology and Obstetrics antenatal clinic.

Sample of the Study Group: The sample of the study was calculated based on the Atalay and Saydam (2014) study results (Maternal Attachment Scale (MBI): Experimental Group X̅+SD: 101.24 ± 4.60 and Control Group X̅+SD: 96.00 9.09) (124). Analysis In Gpower version 3.1.9.7, the effect size (0.727) was calculated according to the power analysis using ''t tests-Means: Difference between two independent means (two groups) '' statistic, with α= 0.05 error level and 95% power. its size; 51 couples in the intervention group and 51 couples in the control group, a total of at least 102 couples . Since the dropout rate in the reference study was 20%, in accordance with this rate, it was planned to carry out the study with a total of 120 couples by adding a total of 18 couples, 9 couples to each group.Random Allocation Software program was used for the randomization of the groups.

Evaluation of Data: Research data will be evaluated in computer environment with appropriate statistical methods. IBM SPSS Statistics 23.0 program was used for statistical analysis and calculations. Statistical significance level was accepted as p<0.05. The conformity of the numerical variables to the normal distribution was evaluated with the Shapiro-Wilk test. The difference between the two independent groups was assessed t test and the Mann-Whitney U test . The relationship between two independent categorical variables was assessed via chi-square analysis

Data Collection Tools:

1.İndividual İnformation Form/ Mother, 2. Prental Attachment İnventory, 3. İndividual İnformation Form/ Father , 4. Intrauterine Father Attachment Scale 5. Maternal Attachment Inventory, 6. Paternal Infant Attachment Scale

Being tested
Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) Model
Keywords
maternal attachment, parenteral attachment, parentering education, prenatal attachment, paternal attachmnet, internet-based education, Information-Motivation-Behavioral Skills (IMB) Model

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) ModelOther

    Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) Model

Study groups in NCT05744531
Study groupRoleWhat they receive
education groupExperimentalThe healthy pregnant women and their spouses meeting the inclusion criteria were determined by randomization according to the order of application to the antenatal clinic. A guide to providing access to internet-based education, training booklet and attachment diary was given to the pregnant women and their spouses in the education group .Internet-based Parenting education based on the Information-Motivation-Behavioral Skills (IMB) Model was given to the pregnant women and their spouses in the education group , once a week between 31 and 34 weeks of gestation, for a total of 4 times. . Internet-based counseling was given to the pregnant women and their spouses in the education group as part of the motivation step of the model,
Receives: Other: Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) Model
control groupNo interventionThe healthy pregnant women and their spouses meeting the inclusion criteria were determined by randomization according to the order of application to the antenatal clinic. A guide to providing access to internet-based education, training booklet and attachment diary was not given to the pregnant women and their spouses in the control group. No training was given to the pregnant women and their spouses in the control group.Counseling was not provided to the pregnant women and their spouses in the control group. .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Attachment

    maternal attachment level measured by Maternal Attachment Inventory .It is a 4-point Likert-type scale with 26 items. Each item directly. It is always (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points, and never (d) = 1 point.Test scored between 26-104. A high score indicates high maternal attachment

    Measured: 3nd month after birth

  2. Paternal Infant Attachment Scale

    paternal attachment level measured by Paternal Infant Attachment Scale. The scale has three sub-dimensions and 19 items. The sub-dimensions of the scale include "Patience and Tolerance", "Pleasure in Interaction", "Love and Pride". Each item of the scale is scored between one and five points, and the score that can be obtained from the scale varies between 19 and 95.

    Measured: 3nd month after birth

Secondary outcomes (2)
  1. Prenatal Attachment

    Prenatal attachment level measured by Prental Attachment İnventory. The scale is applied in the prenatal period from the 28th gestational week until the birth. The PCI consists of 21 items in total and the items in the scale are scored on a four-point Likert scale that can range from 1 to 4. A minimum of 21 and a maximum of 84 points can be obtained from the scale.

    Test scored between 21-84

    Measured: within 1 week after education

  2. Intrauterine Father Attachment Scale

    Intrauterine Father Attachment level measured by Intrauterine Father Attachment Scale . The scale consists of 23 items and is a four-point Likert scale. The scale does not have a cutoff point. The higher the mean score obtained from the scale, the higher the level of attachment of fathers to their babies Test scored between 23-92.

    Measured: within 1 week after education

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start1 Mar 2021
  3. Primary completion1 Dec 2021
  4. Study completion1 Dec 2021

Resources

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
Model description
There will be two group. One is interventional group; other is control group.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05744531
Sponsor's protocol ID
aybu sbe
Status last verified
Feb 2023
First submitted
22 Mar 2022
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manav AI, Gozuyesil E, Tar E. The Effects of the Parenting Education Performed through Whatsapp on the Level of Maternal-Paternal and Infant Attachment in Turkey. J Pediatr Nurs. 2021 Nov-Dec;61:e57-e64. doi: 10.1016/j.pedn.2021.04.018. Epub 2021 Apr 26.

    PubMed 33926747

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based Parenting Education based on the information -Motivation-Behavioral Skills (IMB) Model in people with Parenting and Maternal-Fetal Relations, run by Semra TUNCAY YILMAZ 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 21 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 27 Feb 2023. 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: 3nd month after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05744531, which also lists 1 linked publication.

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 27 Feb 2023.

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