Effectiveness of Calgary Family Intervention Model in Caregivers

January 23, 2024 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Father or mother of infants and toddlers aged from 1 month to 3 years (inclusive) undergoing open-heart surgery.
  2. Infants and toddlers diagnosed with congenital heart disease who are undergoing their first open-heart surgery.
  3. Caregivers who are proficient in the national or Taiwanese language and have normal cognitive abilities.
  4. Caregivers who can read and understand Chinese characters, enabling them to complete the questionnaires.
  5. After explanation and reading of the informed consent, caregivers will provide written consent for participation.

Exclusion Criteria:

  1. Father or mother of newborns who undergoing open-heart surgery within the first month after birth.
  2. Caregivers with mental illness or intellectual disabilities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
The control group receives care according to the standard intensive care unit nursing guidelines.
Experimental: experimental group
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.
Other: Calgary Family Intervention Model
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year
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.
one year
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview Outline
Time Frame: approximately one year.

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:

  1. 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)
  2. How was the emotional interaction within your family before the intervention? Did the intervention have any impact on your family dynamics? (Family Functioning)
  3. 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)
  4. Considering your child's entire hospitalization experience and your participation in this research intervention, do you have any suggestions or thoughts to share?
approximately one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Chi-Wen Chen, doctor, National Yang Ming Chiao Tung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202306120RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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