Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04049890

Development and Validation of Family Adjustment Inventory

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Meyer Children's Hospital

Florence, Firenze, 50139, Italy

Location status: Recruiting

Location contact

Alessandra Bettini, MSc

SUB_INVESTIGATOR

Elena Amore, MSc

SUB_INVESTIGATOR

Laura Vagnoli, MSc

CONTACT

[email protected]

055-5662719 ext. 0039

Rosanna Martin, MSc

CONTACT

[email protected]

347-6852475 ext. 0039

About this study

FAI was developed in two different forms:

  • 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);
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAI-O

Other

Administration of Family Adjustment Inventory in the version "Only-child"

FAI-S

Other

Administration of Family Adjustment Inventory in the version "Sibling"

Personal Data Questionnaire

Other

This form requires informations about child, respondent and partner (if any), and evaluates the presence of any distressful event happened during the last year

Primary outcomes

  1. 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

  1. Presence of distressful events happened in the last year

    Time frame: Parents fill in the personal data questionnaire one single time at enrollment

    The presence of distressful events is collected through a personal data questionnaire, specifically designed for this study in accordance to literature in the field

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Vagnoli, MSc

CONTACT

[email protected]

055 5662719 ext. 0039

Rosanna Martin, MSc

CONTACT

[email protected]

055 5662475 ext. 0039

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Collaborators

  • University of Florence

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2026
First posted
Aug 8, 2019
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.