NursingNCT06004622
Effectiveness of Calgary Family Intervention Model in Caregivers
A study testing Calgary Family Intervention Model in people with Nursing, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Effectiveness of Calgary family intervention model improving on uncertainty, family functioning, and resilience in caregivers of infants and toddlers undergoing open-heart surgery.Research hypothesis is The experimental group of caregivers for infants and toddlers undergoing open-heart surgery showed significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing
- What is being tested?
- Calgary Family Intervention Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2024to 14 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Father or mother of infants and toddlers aged from 1 month to 3 years (inclusive) undergoing open-heart surgery.
- Infants and toddlers diagnosed with congenital heart disease who are undergoing their first open-heart surgery.
- Caregivers who are proficient in the national or Taiwanese language and have normal cognitive abilities.
- Caregivers who can read and understand Chinese characters, enabling them to complete the questionnaires.
- After explanation and reading of the informed consent, caregivers will provide written consent for participation.
Who cannot join
- Father or mother of newborns who undergoing open-heart surgery within the first month after birth.
- Caregivers with mental illness or intellectual disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Calgary Family Intervention Model Improving on Uncertainty, Family Functioning, and Resilience in Caregivers of Infants and Toddlers Undergoing Open-heart Surgery.
Effectiveness of Calgary family intervention model improving on uncertainty, family functioning, and resilience in caregivers of infants and toddlers undergoing open-heart surgery.Research hypothesis is The experimental group of caregivers for infants and toddlers undergoing open-heart surgery showed significant differences in uncertainty, family functioning, and family resilience before surgery, prior to transferring out of the intensive care unit, and before discharge.
Read the detailed description
Background: For caregivers of infants and toddlers with congenital heart disease, the experience of their young children undergoing open-heart surgery brings about uncertainty, including waiting for the child's recovery, providing care in the intensive care unit, and the possibility of death. These uncertainties can significantly impact the caregivers' physical and mental well-being, as well as their ability to provide subsequent care and nurture for the child. Therefore, it is crucial to implement intervention measures that focus on caring for the caregivers, reducing their sense of uncertainty, and implementing effective nursing strategies to enhance family functioning and resilience.
Purpose: This study aims to investigate the effectiveness of implementing the Calgary Family Intervention Model on caregivers of infants and toddlers undergoing open-heart surgery in terms of reducing their uncertainty, improving family functioning, and enhancing resilience.
Methods: This study adopts a quasi-experimental research design and will be conducted at a medical center in northern Taiwan. A total of 96 caregivers of infants and toddlers undergoing open-heart surgery will be recruited, and a pre- and post-test design will be employed with two groups. The control group will receive routine nursing care, while the experimental group will receive routine nursing care supplemented with the Calgary Family Intervention Model, which encompasses cognitive, emotional, and behavioral domains. The experimental group will participate in two therapeutic sessions: 1. The day after surgery and before visiting the child, and 2. Prior to transferring out of the intensive care unit. Both groups will be assessed using the parental uncertainty perception scale, APGAR family function assessment scale, and the family resilience scale as outcome measures. Data will be collected before surgery, prior to transferring out of the intensive care unit, and before discharge. Interviews will be conducted with the experimental group, and data analysis will involve Generalized Estimating Equations (GEE) for quantitative data and content analysis for qualitative data.
Expected contributions: In future clinical practice, this study aims to provide valuable insights into the use of family nursing intervention for caregivers of infants and toddlers undergoing open-heart surgery, specifically in managing the uncertainties associated with the illness context. Through therapeutic conversations, this intervention can help identify family strengths and resources, thereby serving as an important reference strategy for enhancing family resilience.
- Conditions
- Nursing
- Being tested
- Calgary Family Intervention Model
- Keywords
- Calgary family intervention model, caregiver, uncertainty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calgary Family Intervention ModelOther
under two brief therapeutic sessions using the Calgary Family Intervention Model. Each session lasted about 20 minutes and was conducted by a single researcher to maintain consistency. The scheduling of these sessions took into consideration the physiological and emotional stability of the participants. If any issues or difficulties arose during the course of the sessions, they could be paused. The confidentiality and privacy of the discussion content were ensured. The intervention took place in a dedicated room within the intensive care unit, providing sufficient space and privacy.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The control group receives care according to the standard intensive care unit nursing guidelines. |
| experimental group | Experimental | The experimental group, in addition to following the standard guidelines, undergoes two brief therapeutic sessions using the Calgary Family Intervention Model. Each session lasts approximately 20 minutes. Both groups complete three questionnaires during the study period. Furthermore, after the study concludes, the experimental group participates in an interview lasting approximately 15 minutes before returning home. Receives: Other: Calgary Family Intervention Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
parental uncertainty perception scale
The Chinese questionnaire consists of 30 items, categorized into four domains: Ambiguity, Lack of Clarity, Lack of Information, and Unpredictability. The scoring method is based on the Likert scale, with scores ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). The possible total score ranges from 30 to 150, with the overall score being the sum of individual item scores. A higher total score indicates a greater sense of uncertainty.
Measured: one year
APGAR family function assessment scale
The questionnaire encompasses five subscales: Adaptation, Partnership, Growth, Affection, and Resolve. Each subscale consists of one question. A 3-point scoring system is employed, where "Often" is scored as 2 points, "Sometimes" as 1 point, and "Hardly Ever" as 0 points. The total score ranges from 0 to 10. Scores between 7 and 10 indicate a functional family, scores between 4 and 6 suggest a moderately dysfunctional family, and scores from 0 to 3 denote a severely dysfunctional family. In other words, higher scores reflect better family functionality, demonstrating the family's ability to effectively handle problems and make harmonious decisions.
Measured: one year
family resilience scale
The content of this questionnaire consists of 31 items, categorized into three domains: Belief System, Organizational Patterns, and Family Communication Process. The scoring of the questionnaire utilizes a five-point Likert scale, ranging from a minimum of 1 to a maximum of 5. The scale includes responses of "Strongly Disagree" (1 point), "Disagree" (2 points), "Neutral" (3 points), "Agree" (4 points), and "Strongly Agree" (5 points). The total score range is from 31 to 155 points. Higher scores indicate greater family resilience.
Measured: one year
Secondary outcomes (1)
Interview Outline
Interview Content Based on the research questions, design four open-ended questions to understand the effectiveness of receiving the second Calgary Family Intervention in terms of uncertainty, family functioning, and family resilience:
- Before participating in the intervention, what were your worries and concerns about your child? After receiving the intervention, have these worries changed in terms of their intensity? (Uncertainty)
- How was the emotional interaction within your family before the intervention? Did the intervention have any impact on your family dynamics? (Family Functioning)
- How did your family approach crises before the intervention? How has your family's confidence in overcoming challenges changed after participating in the intervention? (Family Resilience)
- Considering your child's entire hospitalization experience and your participation in this research intervention, do you have any suggestions or thoughts to share?
Measured: approximately one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start3 Jan 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Wen Chen, doctor, Study director, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004622
- Sponsor's protocol ID
- 202306120RINA
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2023
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Calgary Family Intervention Model Improving on Uncertainty, Family Functioning, and Resilience in Caregivers of Infants and Toddlers Undergoing Open-heart Surgery.
- ClinicalTrials.gov ID
- NCT06004622
- Acronym / sponsor ID
- 202306120RINA
- Conditions
- Nursing
- Keywords
- Calgary family intervention model, caregiver, uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 22 Aug 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.
Effectiveness of Calgary family intervention model improving on uncertainty, family functioning, and resilience in caregivers of infants and toddlers undergoing open-heart surgery.Research hypothesis is The experimental group of caregivers for infants and toddlers undergoing open-heart surgery showed significant differences in uncertainty, family functioning, and family resilience before surgery, prior to transferring out of the intensive care unit, and before discharge.
Detailed description
Background: For caregivers of infants and toddlers with congenital heart disease, the experience of their young children undergoing open-heart surgery brings about uncertainty, including waiting for the child's recovery, providing care in the intensive care unit, and the possibility of death. These uncertainties can significantly impact the caregivers' physical and mental well-being, as well as their ability to provide subsequent care and nurture for the child. Therefore, it is crucial to implement intervention measures that focus on caring for the caregivers, reducing their sense of uncertainty, and implementing effective nursing strategies to enhance family functioning and resilience.
Purpose: This study aims to investigate the effectiveness of implementing the Calgary Family Intervention Model on caregivers of infants and toddlers undergoing open-heart surgery in terms of reducing their uncertainty, improving family functioning, and enhancing resilience.
Methods: This study adopts a quasi-experimental research design and will be conducted at a medical center in northern Taiwan. A total of 96 caregivers of infants and toddlers undergoing open-heart surgery will be recruited, and a pre- and post-test design will be employed with two groups. The control group will receive routine nursing care, while the experimental group will receive routine nursing care supplemented with the Calgary Family Intervention Model, which encompasses cognitive, emotional, and behavioral domains. The experimental group will participate in two therapeutic sessions: 1. The day after surgery and before visiting the child, and 2. Prior to transferring out of the intensive care unit. Both groups will be assessed using the parental uncertainty perception scale, APGAR family function assessment scale, and the family resilience scale as outcome measures. Data will be collected before surgery, prior to transferring out of the intensive care unit, and before discharge. Interviews will be conducted with the experimental group, and data analysis will involve Generalized Estimating Equations (GEE) for quantitative data and content analysis for qualitative data.
Expected contributions: In future clinical practice, this study aims to provide valuable insights into the use of family nursing intervention for caregivers of infants and toddlers undergoing open-heart surgery, specifically in managing the uncertainties associated with the illness context. Through therapeutic conversations, this intervention can help identify family strengths and resources, thereby serving as an important reference strategy for enhancing family resilience.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The control group receives care according to the standard intensive care unit nursing guidelines. |
| experimental group | Experimental | Other: Calgary Family Intervention ModelThe experimental group, in addition to following the standard guidelines, undergoes two brief therapeutic sessions using the Calgary Family Intervention Model. Each session lasts approximately 20 minutes. Both groups complete three questionnaires during the study period. Furthermore, after the study concludes, the experimental group participates in an interview lasting approximately 15 minutes before returning home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Father or mother of infants and toddlers aged from 1 month to 3 years (inclusive) undergoing open-heart surgery.
- Infants and toddlers diagnosed with congenital heart disease who are undergoing their first open-heart surgery.
- Caregivers who are proficient in the national or Taiwanese language and have normal cognitive abilities.
- Caregivers who can read and understand Chinese characters, enabling them to complete the questionnaires.
- After explanation and reading of the informed consent, caregivers will provide written consent for participation.
Key exclusion criteria (2 listed)
- Father or mother of newborns who undergoing open-heart surgery within the first month after birth.
- Caregivers with mental illness or intellectual disabilities.
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 |
|---|---|---|
| Calgary Family Intervention Modelunder two brief therapeutic sessions using the Calgary Family Intervention Model. Each session lasted about 20 minutes and was conducted by a single researcher to maintain consistency. The scheduling of these sessions took into consideration the physiological and emotional stability of the participants. If any issues or difficulties arose during the course of the sessions, they could be paused. The confidentiality and privacy of the discussion content were ensured. The intervention took place in a dedicated room within the intensive care unit, providing sufficient space and privacy. | Other | experimental group |
Primary outcome
parental uncertainty perception scale
Time frame: one year
The Chinese questionnaire consists of 30 items, categorized into four domains: Ambiguity, Lack of Clarity, Lack of Information, and Unpredictability. The scoring method is based on the Likert scale, with scores ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). The possible total score ranges from 30 to 150, with the overall score being the sum of individual item scores. A higher total score indicates a greater sense of uncertainty.
APGAR family function assessment scale
Time frame: one year
The questionnaire encompasses five subscales: Adaptation, Partnership, Growth, Affection, and Resolve. Each subscale consists of one question. A 3-point scoring system is employed, where "Often" is scored as 2 points, "Sometimes" as 1 point, and "Hardly Ever" as 0 points. The total score ranges from 0 to 10. Scores between 7 and 10 indicate a functional family, scores between 4 and 6 suggest a moderately dysfunctional family, and scores from 0 to 3 denote a severely dysfunctional family. In other words, higher scores reflect better family functionality, demonstrating the family's ability to effectively handle problems and make harmonious decisions.
family resilience scale
Time frame: one year
The content of this questionnaire consists of 31 items, categorized into three domains: Belief System, Organizational Patterns, and Family Communication Process. The scoring of the questionnaire utilizes a five-point Likert scale, ranging from a minimum of 1 to a maximum of 5. The scale includes responses of "Strongly Disagree" (1 point), "Disagree" (2 points), "Neutral" (3 points), "Agree" (4 points), and "Strongly Agree" (5 points). The total score range is from 31 to 155 points. Higher scores indicate greater family resilience.
1 secondary outcome
Interview Outline
Time frame: approximately one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- The illness beliefs model: Advancing practice knowledge about illness beliefs, family healing, and family interventions.Link provided by the sponsor.
- Family Functioning and Congenital Heart Disease.Link provided by the sponsor.
- Family resilience and its association with psychosocial adjustment of children with chronic illness: A latent profile analysis.Link provided by the sponsor.
- Risk factors for low cardiac output syndrome in children with congenital heart disease undergoing cardiac surgery: A retrospective cohort study.Link provided by the sponsor.
- Family resilience in the oncology setting: Development of an integrative framework.Link provided by the sponsor.
- Family-focused public health: Supporting homes and families in policy and practice.Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
Chi-Wen Chen, doctor study director
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calgary Family Intervention Model in people with Nursing, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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: finished, as of the sponsor's last update on 7 Oct 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parental uncertainty perception scale (time frame: one year). The study lists 3 primary outcomes in all. 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 7 Oct 2026.