Randomised Controlled TrialInfant CareNCT06969248
Program to Increase Fathers' Involvement in Infant Care
A study testing Intervention Group in people with Randomised Controlled Trial and Public Health Nursing, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Fathers participating in the study will be given an 8-week formality intervention. Participants will be shown 4-week infant care training records and then 4-week videos prepared on educational topics. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Randomised Controlled Trial, Public Health Nursing, Child Health
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a healthy baby between 4-12 months old,
- Being a first-time father,
- Volunteering to participate in the study,
- Having a smartphone
Who cannot join
- Being under 18 years old,
- Having a psychiatric diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Interventions Targeted to Fathers on Fathers' Participation in Infant Care, Attachment Status, and Paternal Depression: A Randomized Controlled Trial
Fathers participating in the study will be given an 8-week formality intervention. Participants will be shown 4-week infant care training records and then 4-week videos prepared on educational topics. The effect of the intervention will be determined annually by the mean scores of the Fathers' Participation in Infant Care Questionnaire, Father Infant Attachment Scale, and Edinburgh Postpartum Depression Scale.
Read the detailed description
The study will be conducted in a Family Health Center in Turkey, selected by random lottery. Fathers who are registered in a family health center and have babies aged 4-12 months and fathers who have children for the first time will be included in the study. The type of the study is planned as randomized controlled pre-test post-test, parallel group experimental type. A total of 80 fathers will be included in the study, 40 in each group, according to the calculation made with Gpower analysis. Participants will be randomly assigned to groups. Nursing interventions will last for 8 weeks and participants will be given training and watched videos during this process.
- Being tested
- Intervention Group
- Keywords
- fathers' involvement in infant care, Edinburgh Postpartum Depression Scale., Father-Infant Attachment, Child Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Fathers will be provided with a total of 8 weeks of training and videos. The training will cover the role of fatherhood and its historical development, the developmental stages and care needs of babies, ways for fathers to participate in baby care and the benefits of participation, father-infant bonding and influencing factors, and paternal depression. Videos on the subject will be shared with fathers.
| Study group | Role | What they receive |
|---|---|---|
| Non-Intervention Group | No intervention | Fathers in the control group will continue their routine practices. Fathers in this group will be measured twice, pre-test and post-test. No intervention will be made to the control group. After the intervention group's training is completed, training contents and videos will be shared with the control group. |
| Intervention Group | Experimental | Not described Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fathers' Involvement in Infant Care Questionnaire
Measured: 8 week
Father Infant Attachment Scale
Measured: 8 week
Edinburgh Postpartum Depression Scale
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
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 Randomised Controlled TrialStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Tuba Demirel, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969248
- Sponsor's protocol ID
- 9278
- Other IDs
- TUSEB
- Acronym
- Infant Care
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Interventions Targeted to Fathers on Fathers' Participation in Infant Care, Attachment Status, and Paternal Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06969248
- Acronym / sponsor ID
- Infant Care / 9278
- Keywords
- fathers' involvement in infant care, Edinburgh Postpartum Depression Scale., Father-Infant Attachment, Child Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 13 May 2025 (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.
Fathers participating in the study will be given an 8-week formality intervention. Participants will be shown 4-week infant care training records and then 4-week videos prepared on educational topics. The effect of the intervention will be determined annually by the mean scores of the Fathers' Participation in Infant Care Questionnaire, Father Infant Attachment Scale, and Edinburgh Postpartum Depression Scale.
Detailed description
The study will be conducted in a Family Health Center in Turkey, selected by random lottery. Fathers who are registered in a family health center and have babies aged 4-12 months and fathers who have children for the first time will be included in the study. The type of the study is planned as randomized controlled pre-test post-test, parallel group experimental type. A total of 80 fathers will be included in the study, 40 in each group, according to the calculation made with Gpower analysis. Participants will be randomly assigned to groups. Nursing interventions will last for 8 weeks and participants will be given training and watched videos during this process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Non-Intervention Group | No intervention | –Fathers in the control group will continue their routine practices. Fathers in this group will be measured twice, pre-test and post-test. No intervention will be made to the control group. After the intervention group's training is completed, training contents and videos will be shared with the control group. |
| Intervention Group | Experimental | Behavioral: Intervention Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a healthy baby between 4-12 months old,
- Being a first-time father,
- Volunteering to participate in the study,
- Having a smartphone
Key exclusion criteria (2 listed)
- Being under 18 years old,
- Having a psychiatric diagnosis.
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 |
|---|---|---|
| Intervention GroupFathers will be provided with a total of 8 weeks of training and videos. The training will cover the role of fatherhood and its historical development, the developmental stages and care needs of babies, ways for fathers to participate in baby care and the benefits of participation, father-infant bonding and influencing factors, and paternal depression. Videos on the subject will be shared with fathers. | Behavioural | Intervention Group |
Primary outcome
Fathers' Involvement in Infant Care Questionnaire
Time frame: 8 week
Father Infant Attachment Scale
Time frame: 8 week
Edinburgh Postpartum Depression Scale
Time frame: 8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Randomised Controlled Trial
RecruitingPhase 4
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
Head and Neck Cancer (H&N), Free Tissue Flaps
Active, not recruiting
Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
Vascular Access Devices, Catheters
Not yet recruiting
The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance
Student Nursing, Simulation Training
Enrolling by invitation
Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients
Depressive Disorder, Anxiety
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
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 Intervention Group in people with Randomised Controlled Trial and Public Health Nursing, run by Selcuk 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fathers' Involvement in Infant Care Questionnaire (time frame: 8 week). The study lists 3 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 NCT06969248, 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 13 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.