Adjustment ReactionNCT04049890
Development and Validation of Family Adjustment Inventory
An observational study of Adjustment Reaction, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adjustment Reaction
- What is being tested?
- FAI-O, FAI-S and Personal Data Questionnaire
- How many people
- 900 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2016to 14 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parents of patient with a child sufferinf from a chronic illness and treated in the hospital for this condition .
Who may be able to join
- 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
Who cannot join
- cognitive impairment
- no good knowledge of italian language
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Meyer Children's Hospital
Florence, Firenze, 50139
Rosanna Martin, MSc, 347-6852475 ext. 0039, rosanna.martin@meyer.it
Laura Vagnoli, MSc, 055-5662719 ext. 0039, laura.vagnoli@meyer.it
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Adjustment Reaction
- Being tested
- FAI-O, FAI-S, Personal Data Questionnaire
- Keywords
- adjustment, family functioning, chronic disease, emotions
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAI-OOther
Administration of Family Adjustment Inventory in the version "Only-child"
FAI-SOther
Administration of Family Adjustment Inventory in the version "Sibling"
Personal Data QuestionnaireOther
This form requires informations about child, respondent and partner (if any), and evaluates the presence of any distressful event happened during the last year
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: FAI-O; Other: Personal Data Questionnaire | |
| 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 Receives: Other: FAI-S; Other: Personal Data Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived family adjustment
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.
Measured: Parents fill in the FAI one single time at enrollment
Secondary outcomes (1)
Presence of distressful events happened in the last year
The presence of distressful events is collected through a personal data questionnaire, specifically designed for this study in accordance to literature in the field
Measured: Parents fill in the personal data questionnaire one single time at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start15 Mar 2016
- Primary completion14 Sep 2024
- Study completion14 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adjustment ReactionStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Principal investigator, Rosanna Martin, Meyer Children's Hospital IRCCS
- Investigators
- Francesca Maffei, Msc, Study director, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049890
- Sponsor's protocol ID
- FAI
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2019
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aneshensel CS, Pearlin LI, Mullan JT, Zarit SH, Whitlatch CJ (1995). Profiles in caregiving: the unexpected career. San Diego Academic Press, Inc.
Boer LM, Daudey L, Peters JB, Molema J, Prins JB, Vercoulen JH. Assessing the stages of the grieving process in chronic obstructive pulmonary disease (COPD): validation of the Acceptance of Disease and Impairments Questionnaire (ADIQ). Int J Behav Med. 2014 Jun;21(3):561-70. doi: 10.1007/s12529-013-9312-3.
PubMed 23645551Bonner MJ, Hardy KK, Guill AB, McLaughlin C, Schweitzer H, Carter K. Development and validation of the parent experience of child illness. J Pediatr Psychol. 2006 Apr;31(3):310-21. doi: 10.1093/jpepsy/jsj034. Epub 2005 May 25.
PubMed 15917492Klassen AF, Raina P, McIntosh C, Sung L, Klaassen RJ, O'Donnell M, Yanofsky R, Dix D. Parents of children with cancer: which factors explain differences in health-related quality of life. Int J Cancer. 2011 Sep 1;129(5):1190-8. doi: 10.1002/ijc.25737. Epub 2010 Dec 17.
PubMed 21064097McCubbin 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.
Raina P, O'Donnell M, Schwellnus H, Rosenbaum P, King G, Brehaut J, Russell D, Swinton M, King S, Wong M, Walter SD, Wood E. Caregiving process and caregiver burden: conceptual models to guide research and practice. BMC Pediatr. 2004 Jan 14;4:1. doi: 10.1186/1471-2431-4-1.
PubMed 14723791Raina P, O'Donnell M, Rosenbaum P, Brehaut J, Walter SD, Russell D, Swinton M, Zhu B, Wood E. The health and well-being of caregivers of children with cerebral palsy. Pediatrics. 2005 Jun;115(6):e626-36. doi: 10.1542/peds.2004-1689.
PubMed 15930188Rossi Ferrario S, Baiardi P, Zotti AM. Update on the family strain questionnaire: a tool for the general screening of caregiving-related problems. Qual Life Res. 2004 Oct;13(8):1425-34. doi: 10.1023/B:QURE.0000040795.78742.72.
PubMed 15503838
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Instrument to Evaluate Parents' Adjustment to Their Child's Chronic Disease: the Family Adjustment Inventory
- ClinicalTrials.gov ID
- NCT04049890
- Acronym / sponsor ID
- FAI
- Conditions
- Adjustment Reaction
- Keywords
- adjustment, family functioning, chronic disease, emotions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2026 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of children with a chronic disease with no siblings | – | Other: FAI-O, Other: Personal Data QuestionnaireParents of children suffering from a chronic disease who has no brother or sister over 3 years of age |
| Parents of children with a chronic disease with siblings | – | Other: FAI-S, Other: Personal Data QuestionnaireParents of children suffering from a chronic disease who one or more sibling over the age of 3 years old |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of patient with a child sufferinf from a chronic illness and treated in the hospital for this condition .
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- cognitive impairment
- no good knowledge of italian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAI-OAdministration of Family Adjustment Inventory in the version "Only-child" | Other | Parents of children with a chronic disease with no siblings |
| FAI-SAdministration of Family Adjustment Inventory in the version "Sibling" | Other | Parents of children with a chronic disease with siblings |
| Personal Data QuestionnaireThis form requires informations about child, respondent and partner (if any), and evaluates the presence of any distressful event happened during the last year | Other | Parents of children with a chronic disease with no siblings, Parents of children with a chronic disease with siblings |
Primary outcome
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.
1 secondary outcome
Presence of distressful events happened in the last year
Time frame: Parents fill in the personal data questionnaire one single time at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- BackgroundAneshensel CS, Pearlin LI, Mullan JT, Zarit SH, Whitlatch CJ (1995). Profiles in caregiving: the unexpected career. San Diego Academic Press, Inc.
- Background: PubMed 23645551Boer LM, Daudey L, Peters JB, Molema J, Prins JB, Vercoulen JH. Assessing the stages of the grieving process in chronic obstructive pulmonary disease (COPD): validation of the Acceptance of Disease and Impairments Questionnaire (ADIQ). Int J Behav Med. 2014 Jun;21(3):561-70. doi: 10.1007/s12529-013-9312-3.
- Background: PubMed 15917492Bonner MJ, Hardy KK, Guill AB, McLaughlin C, Schweitzer H, Carter K. Development and validation of the parent experience of child illness. J Pediatr Psychol. 2006 Apr;31(3):310-21. doi: 10.1093/jpepsy/jsj034. Epub 2005 May 25.
- Background: PubMed 21064097Klassen AF, Raina P, McIntosh C, Sung L, Klaassen RJ, O'Donnell M, Yanofsky R, Dix D. Parents of children with cancer: which factors explain differences in health-related quality of life. Int J Cancer. 2011 Sep 1;129(5):1190-8. doi: 10.1002/ijc.25737. Epub 2010 Dec 17.
- BackgroundMcCubbin 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.
- Background: PubMed 14723791Raina P, O'Donnell M, Schwellnus H, Rosenbaum P, King G, Brehaut J, Russell D, Swinton M, King S, Wong M, Walter SD, Wood E. Caregiving process and caregiver burden: conceptual models to guide research and practice. BMC Pediatr. 2004 Jan 14;4:1. doi: 10.1186/1471-2431-4-1.
- Background: PubMed 15930188Raina P, O'Donnell M, Rosenbaum P, Brehaut J, Walter SD, Russell D, Swinton M, Zhu B, Wood E. The health and well-being of caregivers of children with cerebral palsy. Pediatrics. 2005 Jun;115(6):e626-36. doi: 10.1542/peds.2004-1689.
- Background: PubMed 15503838Rossi Ferrario S, Baiardi P, Zotti AM. Update on the family strain questionnaire: a tool for the general screening of caregiving-related problems. Qual Life Res. 2004 Oct;13(8):1425-34. doi: 10.1023/B:QURE.0000040795.78742.72.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Maffei, Msc study director
Meyer Children's Hospital IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adjustment Reaction, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosanna Martin, MSc (055 5662475 ext. 0039, rosanna.martin@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived family adjustment (time frame: Parents fill in the FAI one single time at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049890, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.