Clinical trial NCT06905678: The Financial and Emotional Impact of Cleft Palate
Official title: The Financial and Emotional Impact of Cleft Palate on Children and Their Caregivers: a Mixed-method Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cleft Lip and Cleft Palate
Keywords: Cleft lip and palate
Emotional burden
Financial burden
Questionnaires
Perceptions
Interviews
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2025-04-01
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are children/young adults with a cleft (lip and) palate and their parents/caregivers. To verify some results a control group is included consisting of healthy children/young adults and their parents/caregivers.

Brief summary: Cleft lip and/or palate (CL±P) is the most prevalent congenital craniofacial defect with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. WHO highlights the significant financial costs, including morbidity, healthcare costs, emotional distress and social exclusion to patients, their families and society. The purpose of this study is to investigate the financial and emotional impact of CL±P based on the perceptions of children with CL±P and their parents/guardians followed by the interdisciplinary craniofacial teams of the University Hospitals of Leuven or Ghent. Participation in this study consists of completing questionnaires related to financial, social and well-being aspects using the CLEFT-Q, Parental Stress Scale and a financial impact questionnaire. The parents/guardians of the children aged 5 years always complete all questionnaires. The parents/guardians of the 12- and 18-year-old children complete the Parental Stress Scale and a financial impact questionnaire. The children aged 18 complete the CLEFT-Q themselves. Questionnaires can be delivered online or on paper. The outcomes on the health-related QoL of children with cleft and the PSS are compared with the outcomes of 'healthy' children and their parents/guardians to ensure that the emotional impact is attributable to the cleft. In addition, children and their parents/guardians can participate in a semi-structured interview. During the interview appointment, the questionnaires can be completed on paper. Potential participants will be told that the interview will be recorded and that all findings will be kept confidential. The actual interviews will take place at a location and time that is most convenient for the participants. Participants do not need to come to UZ Gent or UZ Leuven for this. Each interview will be recorded with a Roland R-05 high quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographic data. In addition, data regarding the type of cleft, diagnoses, observation sheets and consultation letters will be collected from the medical records of the children with CL±P. We also aim to investigate whether variations in these effects are observable based on the specific type of cleft. All participants will go through the same protocol regardless of recruitment through UZ Gent or UZ Leuven.


Eligibility criteria: Inclusion Criteria:

* Presence of a cleft (lip and) palate
* Age of 5, 12 or 18 years

Exclusion Criteria:

- No specific exclusion criteria

Primary outcomes:
measure: Financial burden of a cleft
timeFrame: 2 months
measure: Emotional burden of a cleft
timeFrame: 2 months
Secondary outcomes:
measure: Differences in impact based on the type of cleft
timeFrame: Through study completion, an average of 1 year
measure: Does the impact decrease as the child gets older
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References: