Effectiveness of Calgary Family Intervention Model in Caregivers

NCT06004622 | Completed

• 1 other identifier: 202306120RINA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 differences in uncertainty, family functioning, and family resilience before surgery, prior to transferring out of the intensive care unit, and before discharge.

Conditions

Nursing

Keywords

Calgary family intervention model; caregiver; uncertainty

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  one year

Secondary Outcomes (1)

• Interview Outline

  approximately one year.

Study Arms (2)

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.

Other: Calgary Family Intervention Model

Interventions

Calgary Family Intervention Model OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

Related Links

• The illness beliefs model: Advancing practice knowledge about illness beliefs, family healing, and family interventions.
• Family Functioning and Congenital Heart Disease.
• Family resilience and its association with psychosocial adjustment of children with chronic illness: A latent profile analysis.
• Risk factors for low cardiac output syndrome in children with congenital heart disease undergoing cardiac surgery: A retrospective cohort study.
• Family resilience in the oncology setting: Development of an integrative framework.
• Family-focused public health: Supporting homes and families in policy and practice.
• The resilient process of the family after diagnosis of childhood chronic illness: A qualitative meta-synthesis.
• A randomized clinical trial of the building on family strengths program: An education program for parents of children with chronic health conditions.
• Mental health problems in parents of children with congenital heart disease.
• Individualized family-centered developmental care: An essential model to address the unique needs of infants with congenital heart disease.
• How should we treat representative neonatal surgical diseases with congenital heart disease?
• Home care experience and nursing needs of caregivers of children undergoing congenital heart disease operations: A qualitative descriptive study.
• Family resilience, parenting styles and psychosocial adjustment of children with chronic illness: A cross-sectional study.
• Resilience and associated factors in mothers of children with congenital heart disease: A cross-sectional study.
• Effects of the family support and psychoeducation program based on the calgary family intervention model on the coping, psychological distress and psychological resilience levels of the family caregivers of chronic psychiatric patients.
• Interventions in post-intensive care syndrome-family: A systematic literature review.
• Incidence and mortality trend of congenital heart disease at the global, regional, and national level, 1990-2017.
• A novel nesting protocol to decrease readmission and increase patient satisfaction following congenital heart surgery.

Study Officials

• Chi-Wen Chen, doctor

  National Yang Ming Chiao Tung University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 22, 2023
• Study Start: January 3, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)