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Clinical Trials/NCT04049890
NCT04049890
Recruiting
Not Applicable

Development and Validation of a New Instrument to Evaluate Parents' Adjustment to Their Child's Chronic Disease: the Family Adjustment Inventory

Meyer Children's Hospital IRCCS1 site in 1 country900 target enrollmentMarch 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adjustment Reaction
Sponsor
Meyer Children's Hospital IRCCS
Enrollment
900
Locations
1
Primary Endpoint
Perceived family adjustment
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

A diagnosis of chronic disease in childhood may be disruptive for families. Some parents show good adjustment, while others may have more difficulties.

Aim of this study is to develop and validate a new psychometric instrument to help precociously detect parents' vulnerability in the process of adjustment to their child's chronic disease at different times of care.

Detailed Description

FAI was developed in two different forms: 1. for parents with one children suffering from a chronic disease or ill children who has siblings younger than 3 years old - FAI-O (only child); 2. for parents with at least two children, the brother/sister of the ill child has 3 years or more- FAS-S (siblings) The two forms are identical, with the exception that FAI-S has an additional dimension with respect to FAI-O, that specifically regards the involvement of siblings in the illness path of the sick brother/sister. Development of FAI followed several steps: * definition of initial instrument dimensions * item wording for each dimension * definition of scoring * focus group with parents of patients suffering from a chronic disease to evaluate item content and linguistic clarity Validation of FAI for each form (FAI-O and FAI-S): Validation consists in several steps, identical for the two versions but in different in timing, depending on the number of admnistration. * first phase: the FAI is administered to parents of patients with different chronic disease (each form needs to reach the total of 300 administrations). * second phase: statistical analysis aimed to obtain the final version of each FAI form (define actual dimensions and most adequate items) * third phase: administration to a new sample of parents of children suffering from a chronic disease (each form needs to reach the total of 150 administrations). * fourth phase: statistical analysis aimed to confirm the adequacy of the instrument

Registry
clinicaltrials.gov
Start Date
March 15, 2016
End Date
September 14, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Meyer Children's Hospital IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Rosanna Martin

Pediatric Psychologist

Meyer Children's Hospital IRCCS

Eligibility Criteria

Inclusion Criteria

  • consent for participating in the study
  • having a child suffering from a chronic illness and treated in the hospital in the following specialties: onco-hematology, neuro-oncology, diabetology, cystic fibrosis, metabolic disease, gastroenterology, cardiology, nephrology, rheumatology, allergology, pneumology, immunology, intensive care unit
  • italian speaking

Exclusion Criteria

  • cognitive impairment
  • no good knowledge of italian language

Outcomes

Primary Outcomes

Perceived family adjustment

Time Frame: Parents fill in the FAI one single time at enrollment

FAI (Family Adjustment Inventory) measures family adjustment. The preliminary versions of FAI-O consists in182 items and FAI-S in197 items, both scored on a 5-point likert scale from 0 to 4. Higher scores represent poorer adjustment.

Secondary Outcomes

  • Presence of distressful events happened in the last year(Parents fill in the personal data questionnaire one single time at enrollment)

Study Sites (1)

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