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RecruitingNCT07627126Updated Jun 4, 2026

Fathers' Involvement in Infant Care and Infants' Development

An observational study in Infant Behavior and Father - Child Relations, sponsored by Nigde Omer Halisdemir University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Nigde Omer Halisdemir University · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
75
Ages
4 Months to 6 Months
Sex
All
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Study summary

In the early stages of life, newborns are dependent on caregivers to meet their basic needs for survival, feeding, and care. Generally, mothers assume primary responsibility for meeting their infants' basic needs and providing care, while fathers take on a supporting role. Both mothers and fathers actively contribute to the baby's healthy emotional development. This study, planned with fathers of 4-6 month old infants, addresses the lack of quantitative evidence regarding the relationship between fathers' involvement in infant care and infants' sensory processing.

Read the detailed description

Research shows that fathers' active participation in infant care positively impacts children's psychological, cognitive, social, and behavioral development. Mothers must encourage shared care between fathers and infants from the very beginning by providing opportunities for fathers to actively participate. Previous studies evaluating fathers' active involvement and infant development have shown that fathers report feeling a strong bond with their infants from birth, and infants show higher levels of motor, language, and personal/social development. However, no studies have been found that examine the relationship between infant sensory processing skills and the father's active involvement in infant care. This study, planned with fathers of 4-6-month-old infants, addresses the lack of quantitative evidence regarding the relationship between fathers' involvement in infant care and infants' sensory processing. Therefore, this study aims to determine the relationship between fathers' involvement in infant care and infants' sensory processing.

02

Conditions studied

  • Infant Behavior
  • Father - Child Relations

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Keywords

  • Infant
  • Sensory Processing
  • Father
  • Infant Care
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In context

Infant Behavior

37 studies on the registry are indexed under Infant Behavior; 5 are open to participants now.

Browse Infant Behavior studies →

Lead sponsor

Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study will include healthy, full-term (37-40 weeks of gestation) infants aged 4 to 6 months.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Term infants (37-40 weeks),
  • Infants aged 4-6 months

Exclusion criteria

Exclusion Criteria:

  • Preterm infants,
  • Infants with congenital infections or proven genetic changes,
  • Infants and mothers diagnosed with metabolic, neurological, and genetic diseases,
  • Children whose parents did not volunteer to study
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy infants

    Healthy, full-term (37-40 weeks of gestation) infants aged 4-6 months old and their families will be invited to participate in the study.

    Behavioral: The Infant Sensory Profile-2 · Behavioral: Fathers' Involvement in Infant Care

Interventions

  • BehavioralThe Infant Sensory Profile-2

    The Infant Sensory Profile-2 is a parent-administered questionnaire that documents the sensory processing patterns of infants from birth to 6 months. In this study, the questionnaire will be completed by mothers. It consists of 25 items assessing different aspects of sensory processing and takes 5-10 minutes to complete. Each item is scored between one and five. The scoring is as follows: Almost Always = 5, Frequently = 4, Sometimes = 3, Rarely = 2, Almost Never = 1, with a parameter of "Not Applicable = 0".

  • BehavioralFathers' Involvement in Infant Care

    The Fathers' Involvement in Infant Care Questionnaire, developed by Kuruçırak and Kulakaç, is a five-point Likert-type instrument designed to assess the level of fathers' involvement in infant care. Responses range from 1 (Never) to 5 (Always); higher scores indicate greater involvement in caregiving activities.

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What researchers measure

Primary outcomes

  1. Fathers' Involvement in Infant Care Questionnaire

    The Fathers' Involvement in Infant Care Questionnaire, developed by Kuruçırak and Kulakaç, is a five-point Likert-type instrument designed to assess the level of fathers' involvement in infant care. Responses range from 1 (Never) to 5 (Always); higher scores indicate greater involvement in caregiving activities. The questionnaire consists of three subscales: (1) Physical Care (13 items), (2) Personal Development and Health (8 items), and (3) Dedicating Time to Play Activities (7 items). In our study, it will be completed by fathers.

    Time frame: 4-6 months

  2. Sensory processing

    The Infant Sensory Profile-2 is a parent-administered questionnaire that documents the sensory processing patterns of infants from birth to 6 months. In this study, the questionnaire will be completed by mothers. It consists of 25 items assessing different aspects of sensory processing and takes 5-10 minutes to complete. Each item is scored between one and five. The scoring is as follows: Almost Always = 5, Frequently = 4, Sometimes = 3, Rarely = 2, Almost Never = 1, with a parameter of "Not Applicable = 0". There are 6 options. The sum of individual scores gives the raw score. The total raw score is classified as: "typical sensory processing" (41-61) and "atypical sensory processing" (0-40 or 62-125).

    Time frame: 4-6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Kim MA, Kim SJ, Cho H. Effects of tactile stimulation by fathers on physiological responses and paternal attachment in infants in the NICU: A pilot study. J Child Health Care. 2017 Mar;21(1):36-45. doi: 10.1177/1367493516666729. Epub 2016 Sep 22. PubMed 27659762 ↗
  • Hall RA, De Waard IE, Tooten A, Hoffenkamp HN, Vingerhoets AJ, van Bakel HJ. From the father's point of view: how father's representations of the infant impact on father-infant interaction and infant development. Early Hum Dev. 2014 Dec;90(12):877-83. doi: 10.1016/j.earlhumdev.2014.09.010. Epub 2014 Oct 21. PubMed 25463835 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07627126
Lead sponsor
Nigde Omer Halisdemir University
Responsible party
Rabia ZORLULAR (principal investigator, Nigde Omer Halisdemir University) — Principal investigator
First posted
Jun 4, 2026
Start date
May 30, 2026
Primary completion
Mar 15, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Jun 4, 2026

Study contacts

Rabia ZORLULAR
Contact
rabiaeraslan118@gmail.com
+5424362082
Rabia Zorlular
Contact
rabiaeraslan118@gmail.com
Rabia ZORLULAR
principal investigator · Nigde Omer Halisdemir University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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