NCT05588089

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

October 12, 2022

Last Update Submit

May 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months

Secondary Outcomes (1)

  • Postpartum Quality of Life Scale

    5 months

Study Arms (2)

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.

Other: Training group

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Yıldırım

Çorum, 19600, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: The study is of a semi-separate type and all women can be trained.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 20, 2022

Study Start

February 4, 2022

Primary Completion

June 28, 2022

Study Completion

September 27, 2022

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations