Development and Validation of Family Adjustment Inventory

February 14, 2025 updated by: Rosanna Martin, Meyer Children's Hospital IRCCS

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

900

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

  • Italy
      • Firenze, Italy, 50139
        • Recruiting
        • Meyer Children's Hospital
        • Contact:
        • Contact:
        • Contact:
          • Alessandra Bettini, MSc
        • Contact:
          • Elena Amore, MSc

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 .

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parents of children with a chronic disease with no siblings
Parents of children suffering from a chronic disease who has no brother or sister over 3 years of age
Other: FAI-O
Administration of Family Adjustment Inventory in the version "Only-child"
Other: Personal Data Questionnaire
This form requires informations about child, respondent and partner (if any), and evaluates the presence of any distressful event happened during the last year
Parents of children with a chronic disease with siblings
Parents of children suffering from a chronic disease who one or more sibling over the age of 3 years old
Other: Personal Data Questionnaire
This form requires informations about child, respondent and partner (if any), and evaluates the presence of any distressful event happened during the last year
Other: FAI-S
Administration of Family Adjustment Inventory in the version "Sibling"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Parents fill in the FAI one single time at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Parents fill in the personal data questionnaire one single time at enrollment

Collaborators and Investigators

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

Sponsor

Meyer Children's Hospital IRCCS

Collaborators

University of Florence

Investigators

  • Study Director: Francesca Maffei, Msc, Meyer Children's Hospital IRCCS

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.

General Publications

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)

March 15, 2016

Primary Completion (Actual)

September 14, 2024

Study Completion (Estimated)

September 14, 2026

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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