NCT06969248

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

May 13, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 5, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

fathers' involvement in infant careEdinburgh Postpartum Depression Scale.Father-Infant AttachmentChild Health

Outcome Measures

Primary Outcomes (3)

  • Fathers' Involvement in Infant Care Questionnaire

    8 week

  • Father Infant Attachment Scale

    8 week

  • Edinburgh Postpartum Depression Scale

    8 week

Study Arms (2)

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a healthy baby between 4-12 months old,
  • Being a first-time father,
  • Volunteering to participate in the study,
  • Having a smartphone

You may not qualify if:

  • Being under 18 years old,
  • Having a psychiatric diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42130, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 3651732BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since the trainings for the experimental group in the study will be conducted by the researcher conducting the study, researcher and participant blinding will not be possible. The data will be analyzed by an independent statistics expert. In this context, statistical blinding will be applied.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

March 5, 2025

First Posted

May 13, 2025

Study Start

January 1, 2025

Primary Completion

June 20, 2025

Study Completion

August 20, 2025

Last Updated

May 13, 2025

Record last verified: 2025-03

Locations