Family Centered CareNCT06057974
Close Collaboration and Discharge Readiness
An observational study of Family Centered Care, run by Nagano Children's Hospital at 1 site in Japan.
Trial summary
This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family Centered Care
- What is being tested?
- Close Collaboration with Parents
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 28 Sep 2023to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants and their parents who need at least 2 weeks of admission to Nagano Children's Hospital NICU, a level IV NICU in Japan.
Who may be able to join
- Infants who have been admitted to the NICU for 2 weeks or longer
Who cannot join
- Infants whose parent doesn't have Japanese as their mother tongue
- Infants whose parent needs psychiatric consultation after birth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Nagano Children's Hospita
Azumino, Nagano, 39982822
Ryo Itoshima, itoshima.ryo@gmail.com
Arata Oda, araoda@gmail.com
About this study
Official title: Effects of the Close Collaboration With Parents Intervention on Parents of Newborns
This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness.
The intervention is planned to be implemented between December 2023 and December 2024.
The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.
Read the detailed description
Study period Pre-intervention data collection phase: September 2023 - December 2023 (Planned) Intervention phase: January 2024 - December 2024 (Planned) Post-intervention data collection phase: January 2025 - April 2025 (Planned)
Outcome measures Primary outcome: Quality of family centered care rated by parents Secondary outcomes: Parental anxiety symptoms and parental discharge readiness
Data management Eligible infants and their information will be identified and collected by research team members and entered into the excel file (.xlsx). Data will be pseudonymized when the data is entered into the excel file. All electronic data will be destroyed 10 years after the initiation of the study.
The principal investigator will be responsible for managing access to the data. We do not have a plan to make the data open in the future.
Statistical analysis The comparison between two continuous variables will be carried out by the student t test and, additionally, the multiple linear regression model and the logistic regression model to adjust the effect of the potential confounders. The potential confounders included in the models will be the length of stay and parents' previous mental illness.
R and RStudio will be used to analyze the data.
- Conditions
- Family Centered Care
- Being tested
- Close Collaboration with Parents
- Keywords
- Staff education, Parental anxiety, Parental discharge readiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Close Collaboration with ParentsOther
The Close Collaboration with Parents intervention is an educational model for healthcare staff working in NICUs. It aims to improve the ability of the members of the NICU healthcare team to I) observe the infants' individual behaviors and needs, II) support parents to take the initiative and share their observations and understanding of their infant's behaviors and to collaboratively plan the infant's care with the healthcare staff, III) understand the individual story of the family regarding parenthood through a dialogue with parents, and IV) involve parents in the decision-making about the care of their baby from an early stage of care through to the preparation for discharge. The final goal is to improve the care culture in the NICUs by changing the attitudes of the healthcare staff and the care practices of the unit to be more in line with family-centered care principles.
It usually takes 1.5 years for each NICU to complete the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | The patient and their parents who are admitted to the NICU before the NICU starts implementing the intervention. | |
| Post-intervention | The patient and their parents who are admitted to the NICU after the NICU implements the intervention. Receives: Other: Close Collaboration with Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of family centered care rated by parents
The family centered care provided by the medical professionals in the NICU is assessed by parents using a questionnaire modified from DigiFCC questions. It consists of 9 questions. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 not applicable). A higher score indicates better family centered care received by parents. The average score of all questions will be used.
This is rated by both parents separately.
Measured: at discharge (about 1 month of age)
Secondary outcomes (2)
Parental anxiety symptoms
Parents' anxiety is assessed using the short version of the State and Trait Anxiety Inventory (Short-STAI). It was developed based on the original STAI which has 40 questions.9 The STAI assesses two different anxiety types at the same time. State anxiety is an emotional response that can change over time according to the situation. Trait anxiety indicates a personal emotional characteristic that a person has. There are 5 questions for each state and trait anxiety and each is scored on a four-point scale (1-4). The total score in each type of anxiety varies from a minimum of 5 to a maximum of 20, and higher scores indicate having more depressive symptoms.
This is rated by both parents separately.
Measured: at discharge (about 1 month of age)
Parental discharge readiness
The readiness for the discharge is measured with the Readiness for Hospital Discharge Scale (RHDS). The questionnaire includes 23 items. Four attributes of readiness for discharge are measured within the subscales: Personal Status (7 items), Knowledge (7 items), Coping Ability (4 items), and Expected Support (5 items). Answers are on a 10-point scale from 0 to 10 (e.g., not at all, totally). The RHDS has been shown to be a reliable and valid measure of patients' perception of readiness for discharge. We use Japanese version, whose validity and reliability have also been shown.
Measured: at discharge (about 1 month of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start28 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Centered CareStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagano Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryo Itoshima, Nagano Children's Hospital
- Investigators
- Ryo Itoshima, MD, Principal investigator, Nagano Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057974
- Sponsor's protocol ID
- S-05-49
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Close Collaboration With Parents Intervention on Parents of Newborns
- ClinicalTrials.gov ID
- NCT06057974
- Acronym / sponsor ID
- S-05-49
- Conditions
- Family Centered Care
- Keywords
- Staff education, Parental anxiety, Parental discharge readiness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nagano Children's HospitalUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Sep 2023 (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.
This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness.
The intervention is planned to be implemented between December 2023 and December 2024.
The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.
Detailed description
Study period Pre-intervention data collection phase: September 2023 - December 2023 (Planned) Intervention phase: January 2024 - December 2024 (Planned) Post-intervention data collection phase: January 2025 - April 2025 (Planned)
Outcome measures Primary outcome: Quality of family centered care rated by parents Secondary outcomes: Parental anxiety symptoms and parental discharge readiness
Data management Eligible infants and their information will be identified and collected by research team members and entered into the excel file (.xlsx). Data will be pseudonymized when the data is entered into the excel file. All electronic data will be destroyed 10 years after the initiation of the study.
The principal investigator will be responsible for managing access to the data. We do not have a plan to make the data open in the future.
Statistical analysis The comparison between two continuous variables will be carried out by the student t test and, additionally, the multiple linear regression model and the logistic regression model to adjust the effect of the potential confounders. The potential confounders included in the models will be the length of stay and parents' previous mental illness.
R and RStudio will be used to analyze the data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | – | –The patient and their parents who are admitted to the NICU before the NICU starts implementing the intervention. |
| Post-intervention | – | Other: Close Collaboration with ParentsThe patient and their parents who are admitted to the NICU after the NICU implements the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants and their parents who need at least 2 weeks of admission to Nagano Children's Hospital NICU, a level IV NICU in Japan.
Key inclusion criteria (1 listed)
- Infants who have been admitted to the NICU for 2 weeks or longer
Key exclusion criteria (2 listed)
- Infants whose parent doesn't have Japanese as their mother tongue
- Infants whose parent needs psychiatric consultation after birth
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 |
|---|---|---|
| Close Collaboration with ParentsThe Close Collaboration with Parents intervention is an educational model for healthcare staff working in NICUs. It aims to improve the ability of the members of the NICU healthcare team to I) observe the infants' individual behaviors and needs, II) support parents to take the initiative and share their observations and understanding of their infant's behaviors and to collaboratively plan the infant's care with the healthcare staff, III) understand the individual story of the family regarding parenthood through a dialogue with parents, and IV) involve parents in the decision-making about the care of their baby from an early stage of care through to the preparation for discharge. The final goal is to improve the care culture in the NICUs by changing the attitudes of the healthcare staff and the care practices of the unit to be more in line with family-centered care principles. It usually takes 1.5 years for each NICU to complete the intervention. | Other | Post-intervention |
Primary outcome
Quality of family centered care rated by parents
Time frame: at discharge (about 1 month of age)
The family centered care provided by the medical professionals in the NICU is assessed by parents using a questionnaire modified from DigiFCC questions. It consists of 9 questions. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 not applicable). A higher score indicates better family centered care received by parents. The average score of all questions will be used. This is rated by both parents separately.
2 secondary outcomes
Parental anxiety symptoms
Time frame: at discharge (about 1 month of age)
Parental discharge readiness
Time frame: at discharge (about 1 month of age)
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 13 Apr 2026.
- 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.
Ryo Itoshima, MD principal investigator
Nagano Children's Hospital
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 Family Centered Care, run by Nagano Children's Hospital at 1 site in Japan.
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 1 inclusion and 2 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 13 Apr 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 Japan. 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 Ryo Itoshima, MD (+358-29-450-5000, ryitos@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of family centered care rated by parents (time frame: at discharge (about 1 month of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.