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Development and Validation of Family Adjustment Inventory

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ClinicalTrials.gov Identifier: NCT04049890
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Rosanna Martin, Meyer Children's Hospital

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.


Condition or disease Intervention/treatment
Adjustment Reaction Other: FAI-O Other: FAI-S Other: Personal Data Questionnaire

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

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development and Validation of a New Instrument to Evaluate Parents' Adjustment to Their Child's Chronic Disease: the Family Adjustment Inventory
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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: FAI-S
Administration of Family Adjustment Inventory in the version "Sibling"

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 .
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049890


Contacts
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Contact: Rosanna Martin, MSc 055 5662475 ext 0039 rosanna.martin@meyer.it
Contact: Laura Vagnoli, MSc 055 5662719 ext 0039 laura.vagnoli@meyer.it

Locations
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Italy
Meyer Children's Hospital Recruiting
Firenze, Italy, 50139
Contact: Rosanna Martin, MSc    347-6852475 ext 0039    rosanna.martin@meyer.it   
Contact: Laura Vagnoli, MSc    055-5662719 ext 0039    laura.vagnoli@meyer.it   
Sub-Investigator: Alessandra Bettini, MSc         
Sub-Investigator: Elena Amore, MSc         
Sponsors and Collaborators
Meyer Children's Hospital
University of Florence
Investigators
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Study Director: Francesca Maffei, Msc Meyer Children's Hospital
Publications:
Aneshensel CS, Pearlin LI, Mullan JT, Zarit SH, Whitlatch CJ (1995). Profiles in caregiving: the unexpected career. San Diego Academic Press, Inc.
McCubbin HI, McCubbin MA, Patterson JM, Cauble AE, Wilson LR, Warwick W. (1983). CHIP Coping Health Inventory for Parents: an assessment of parental coping patterns in the care of the chronically ill child. Journal of Marriage and Family, 45(2), 359-370.

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Responsible Party: Rosanna Martin, Pediatric Psychologist, Meyer Children's Hospital
ClinicalTrials.gov Identifier: NCT04049890    
Other Study ID Numbers: FAI
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosanna Martin, Meyer Children's Hospital:
adjustment
family functioning
chronic disease
emotions
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes