Clinical trial NCT04049890: Development and Validation of Family Adjustment Inventory
Official title: Development and Validation of a New Instrument to Evaluate Parents' Adjustment to Their Child's Chronic Disease: the Family Adjustment Inventory
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adjustment Reaction
Keywords: adjustment
family functioning
chronic disease
emotions
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: University of Florence
First posted: 2019-08-08
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parents of patient with a child sufferinf from a chronic illness and treated in the hospital for this condition .

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

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

Primary outcomes:
measure: Perceived family adjustment
timeFrame: Parents fill in the FAI one single time at enrollment
Secondary outcomes:
measure: Presence of distressful events happened in the last year
timeFrame: Parents fill in the personal data questionnaire one single time at enrollment
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Francesca Maffei, Msc
role: STUDY_DIRECTOR
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