Infant BehaviorNCT07627126
Fathers' Involvement in Infant Care and Infants' Development
An observational study of Infant Behavior and Father - Child Relations, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior, Father - Child Relations
- What is being tested?
- The Infant Sensory Profile-2 and Fathers' Involvement in Infant Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2026to 15 Mar 2027
- Phase
- Observational
- 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 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include healthy, full-term (37-40 weeks of gestation) infants aged 4 to 6 months.
Who may be able to join
- Term infants (37-40 weeks),
- Infants aged 4-6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rabia Zorlular contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nigde Omer Halisdemir University
Niğde
Rabia ZORLULAR, +5424362082, rabiaeraslan118@gmail.com
About this study
Official title: Fathers' Involvement in Infant Care and Infants' Sensory Processing
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.
- Conditions
- Infant Behavior, Father - Child Relations
- Being tested
- The Infant Sensory Profile-2, Fathers' Involvement in Infant Care
- Keywords
- Infant, Sensory Processing, Father, Infant Care
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Infant Sensory Profile-2Behavioural
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".
Fathers' Involvement in Infant CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Infant Sensory Profile-2; Behavioral: Fathers' Involvement in Infant Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 May 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant BehaviorStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Nigde Omer Halisdemir University
- Investigators
- Rabia ZORLULAR, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627126
- Sponsor's protocol ID
- Fathers' Involvement in Infant
- Status last verified
- Apr 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27659762Hall 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fathers' Involvement in Infant Care and Infants' Sensory Processing
- ClinicalTrials.gov ID
- NCT07627126
- Acronym / sponsor ID
- Fathers' Involvement in Infant
- Conditions
- Infant Behavior, Father - Child Relations
- Keywords
- Infant, Sensory Processing, Father, Infant Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy infants | – | Behavioral: The Infant Sensory Profile-2, Behavioral: Fathers' Involvement in Infant CareHealthy, full-term (37-40 weeks of gestation) infants aged 4-6 months old and their families will be invited to participate in the study. |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include healthy, full-term (37-40 weeks of gestation) infants aged 4 to 6 months.
Key inclusion criteria (2 listed)
- Term infants (37-40 weeks),
- Infants aged 4-6 months
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| The Infant Sensory Profile-2The 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". | Behavioural | Healthy infants |
| Fathers' Involvement in Infant CareThe 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. | Behavioural | Healthy infants |
Primary outcome
Fathers' Involvement in Infant Care Questionnaire
Time frame: 4-6 months
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.
Sensory processing
Time frame: 4-6 months
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).
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 4 Jun 2026.
- Results publication: PubMed 27659762Kim 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.
- Results publication: PubMed 25463835Hall 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.
- Individual participant dataSharing planned: No
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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.
Rabia Zorlular contact
Rabia ZORLULAR principal investigator
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Behavior and Father - Child Relations, run by Nigde Omer Halisdemir 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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?
Contact Rabia ZORLULAR (+5424362082, rabiaeraslan118@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fathers' Involvement in Infant Care Questionnaire (time frame: 4-6 months). The study lists 2 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 NCT07627126, which also lists 2 linked publications.
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 4 Jun 2026.