NCT07627126

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress22%
May 2026Mar 2027

First Submitted

Initial submission to the registry

May 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

June 4, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

May 30, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

InfantSensory ProcessingFatherInfant Care

Outcome Measures

Primary Outcomes (2)

  • 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.

    4-6 months

  • 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).

    4-6 months

Study Arms (1)

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-2Behavioral: Fathers' Involvement in Infant Care

Interventions

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".

Healthy infants

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.

Healthy infants

Eligibility Criteria

Age4 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Infant Behavior

Interventions

Infant Care

Condition Hierarchy (Ancestors)

Child BehaviorBehavior

Intervention Hierarchy (Ancestors)

Child CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rabia ZORLULAR

    Nigde Omer Halisdemir University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabia Zorlular

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 4, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

June 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations