MothersBabycareNCT05588089
The Effect of Baby Care Training Given to Fathers After Birth
A study testing Training group in people with Mothers and Fathers, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2022to 27 Sep 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The mother and father are over 18 years old,
- Parents becoming parents for the first time,
- The newborn is healthy, born at term, with the mother and father,
- Parents' knowledge of Turkish,
- Mothers who accepted to participate in the study and received baby care training by participating in the pregnant class,
- Parents' willingness to participate in the research.
Who cannot join
- Having a baby born as a result of a risky pregnancy,
- The newborn is in intensive care,
- Presence of diagnosed psychiatric disease in the mother and father.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Baby Care Training Given to Fathers After Birth on Paternal Attachment, Maternal Postpartum Depression and Quality of Life
The aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.
Read the detailed description
Objective: The aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.
Design: The data for the study were collected using the introductory information form (IIF) and the father-infant attachment scale (FIAS) for fathers, Edinburgh Postpartum Depression Scale and Postpartum Quality of Life Scale for mothers.
Participants and setting: A total of 64 fathers and 64 mothers, including 32 in the intervention group and 32in the control group who met the inclusion criteria of the study were included randomly.
- Being tested
- Training group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupOther
For the experimental group, "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers in the clinic after birth as a pre-test. In the clinic, baby care training was given to fathers practically in 30-35 minutes. After the applied training, the "Baby Care Training Program Content" prepared by the researchers was given to the fathers.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | After the birth of the control group, the "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers as pre-tests in the clinic. After the training, the fathers will be called at the 2nd, 3rd, 4th, 8th and 12th weeks, and the "Fathers' Participation in Baby Care Chart" will be applied 5 times during 12 weeks. In addition, "Father-Infant Attachment Scale" and "Infant Care Questionnaire" were applied to fathers at 12 weeks as posttests. "Personal Information Form for Mothers" will be filled by mothers in the postpartum clinic, mothers are called at 4th, 8th and 12th weeks and "Edinburgh Postpartum Depression Scale" and "Postpartum Quality of Life Scale" are applied. |
| Intervention group | Experimental | For the experimental group, "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers in the clinic after birth as a pre-test. In the clinic, baby care training was given to fathers practically in 30-35 minutes. After the applied training, the "Baby Care Training Program Content" prepared by the researchers was given to the fathers. After the training, the fathers were called at the 2nd, 3rd, 4th, 8th and 12th weeks, and the "Paternals' Participation in Baby Care Chart" was applied 5 times during 12 weeks. In addition, the fathers were called at the 12th week and the "Infant Care Questionnaire Form" was applied as a post-test and the "Father-Infant Attachment Scale" was applied.
"Personal Information Form for Mothers" was applied to the mothers after the birth in the clinic, and the mothers were called at the 4th, 8th and 12th weeks and the "Edinburgh Postpartum Depression Scale" and the "Postpartum Quality of Life Scale" were applied. Receives: Other: Training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postpartum Depression Scale
The scale is a 4-point Likert type and consists of 10 questions. Each question consists of four options and is scored between 0-3. The lowest score that can be obtained from the scale was reported as 0 and the highest score as 30.
Measured: 5 months
Secondary outcomes (1)
Postpartum Quality of Life Scale
This 6-point Likert type scale; kinship-family-friend, health, psychological, socioeconomic and spouse subscale consists of a total of 5 subscales and a total of 40 items.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start4 Feb 2022
- Primary completion28 Jun 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MothersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study is of a semi-separate type and all women can be trained.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588089
- Sponsor's protocol ID
- Hitituniversity
- Acronym
- Babycare
- Status last verified
- May 2024
- First submitted
- 12 Oct 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildirim F, Sahin E. Does father involvement affect attachment and maternal depression and quality of life?: a randomized controlled trial. Fam Pract. 2025 Apr 12;42(3):cmaf024. doi: 10.1093/fampra/cmaf024.
PubMed 40317211
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baby Care Training Given to Fathers After Birth on Paternal Attachment, Maternal Postpartum Depression and Quality of Life
- ClinicalTrials.gov ID
- NCT05588089
- Acronym / sponsor ID
- Babycare / Hitituniversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 20 Oct 2022 (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 provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.
Detailed description
Objective: The aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.
Design: The data for the study were collected using the introductory information form (IIF) and the father-infant attachment scale (FIAS) for fathers, Edinburgh Postpartum Depression Scale and Postpartum Quality of Life Scale for mothers.
Participants and setting: A total of 64 fathers and 64 mothers, including 32 in the intervention group and 32in the control group who met the inclusion criteria of the study were included randomly.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is of a semi-separate type and all women can be trained.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –After the birth of the control group, the "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers as pre-tests in the clinic. After the training, the fathers will be called at the 2nd, 3rd, 4th, 8th and 12th weeks, and the "Fathers' Participation in Baby Care Chart" will be applied 5 times during 12 weeks. In addition, "Father-Infant Attachment Scale" and "Infant Care Questionnaire" were applied to fathers at 12 weeks as posttests. "Personal Information Form for Mothers" will be filled by mothers in the postpartum clinic, mothers are called at 4th, 8th and 12th weeks and "Edinburgh Postpartum Depression Scale" and "Postpartum Quality of Life Scale" are applied. |
| Intervention group | Experimental | Other: Training groupFor the experimental group, "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers in the clinic after birth as a pre-test. In the clinic, baby care training was given to fathers practically in 30-35 minutes. After the applied training, the "Baby Care Training Program Content" prepared by the researchers was given to the fathers. After the training, the fathers were called at the 2nd, 3rd, 4th, 8th and 12th weeks, and the "Paternals' Participation in Baby Care Chart" was applied 5 times during 12 weeks. In addition, the fathers were called at the 12th week and the "Infant Care Questionnaire Form" was applied as a post-test and the "Father-Infant Attachment Scale" was applied. "Personal Information Form for Mothers" was applied to the mothers after the birth in the clinic, and the mothers were called at the 4th, 8th and 12th weeks and the "Edinburgh Postpartum Depression Scale" and the "Postpartum Quality of Life Scale" were applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The mother and father are over 18 years old,
- Parents becoming parents for the first time,
- The newborn is healthy, born at term, with the mother and father,
- Parents' knowledge of Turkish,
- Mothers who accepted to participate in the study and received baby care training by participating in the pregnant class,
Key exclusion criteria (3 listed)
- Having a baby born as a result of a risky pregnancy,
- The newborn is in intensive care,
- Presence of diagnosed psychiatric disease in the mother and father.
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 |
|---|---|---|
| Training groupFor the experimental group, "Personal Information Form for Fathers" and "Infant Care Questionnaire" were applied to the fathers in the clinic after birth as a pre-test. In the clinic, baby care training was given to fathers practically in 30-35 minutes. After the applied training, the "Baby Care Training Program Content" prepared by the researchers was given to the fathers. | Other | Intervention group |
Primary outcome
Edinburgh Postpartum Depression Scale
Time frame: 5 months
The scale is a 4-point Likert type and consists of 10 questions. Each question consists of four options and is scored between 0-3. The lowest score that can be obtained from the scale was reported as 0 and the highest score as 30.
1 secondary outcome
Postpartum Quality of Life Scale
Time frame: 5 months
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 28 May 2024.
- Derived from this study: PubMed 40317211Yildirim F, Sahin E. Does father involvement affect attachment and maternal depression and quality of life?: a randomized controlled trial. Fam Pract. 2025 Apr 12;42(3):cmaf024. doi: 10.1093/fampra/cmaf024.
- 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 Training group in people with Mothers and Fathers, run by Hitit 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 6 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: finished, as of the sponsor's last update on 28 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?
Edinburgh Postpartum Depression Scale (time frame: 5 months). 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 NCT05588089, 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 28 May 2024.