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

Overview

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.

Interventions

• Other Questionnaires
  The participants will fin in questionnaires about the financial and emotional burden they experience.
• Other Semi-structured interviews
  After the participants have filled in the questionnaires they will get the chance to participate in an interview to talk about their perceptions and experiences.

Primary outcome measures

• Financial burden of a cleft [Time frame: 2 months]
• Emotional burden of a cleft [Time frame: 2 months]

Secondary outcome measures (2)

• Differences in impact based on the type of cleft [Time frame: Through study completion, an average of 1 year]
• Does the impact decrease as the child gets older [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\- No specific exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Belgium · 1 center

• Ghent University Hospital — Ghent

Identifiers

NCT: NCT06905678 · ONZ-2024-0282

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗