The Financial and Emotional Impact of Cleft Palate

The Financial and Emotional Impact of Cleft Palate on Children and Their Caregivers: a Mixed-method Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cleft Lip and Cleft Palate
• Intervention / Treatment: Other: Questionnaires; Other: Semi-structured interviews

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Tara Mouton; Phone Number: +32 496 44 63 08; Email: tara.mouton@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Kristiane Van Lierde; Phone Number: +32 9 332 01 43; Email: kristiane.vanlierde@uzgent.be
    • Contact: Tara Mouton; Phone Number: +32 9 332 01 43; Email: tara.mouton@ugent.be
    • Contact: Kristiane Van Lierde, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- No specific exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children/young adults with cleft lip and/or palate; This group are children and young adults with a cleft lip and/or a cleft palate. They are 5, 12 or 22 years old.	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.
Children/young adults without a cleft; This group consists of healthy children and young adults. They will be age and gender matched to the group of children/young adults with a cleft.	Other: Questionnaires; The participants will fin in questionnaires about the financial and emotional burden they experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Financial burden of a cleft	The parents of children with a cleft will fill in a questionnaire regarding the costs of having a child with a cleft. Using this information and de electronic patient record the investigators can calculate the estimated cost of having a child with a cleft.	2 months
Emotional burden of a cleft	Using questionnaires the emotional burden of a cleft will be examined. The parents of the children with a cleft will fill in the Parental Stress Scale (18 items that evaluate parents' feelings about their parental role, with both positive and negative aspects of parenting), and the children with a cleft will fill in the CLEFT-Q (a comprehensive Patient-Reported Outcome Measure (PROM) evaluating QoL, facial function and assessment of appearance).	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in impact based on the type of cleft	The investigators want to examine if the results on the questionnaire will be different based on the type of cleft. Participants filled in the questionnaires on which type of cleft they have. The results are then reviewed and compared to see if the results obtained depend on the type of cleft.	Through study completion, an average of 1 year
Does the impact decrease as the child gets older	The investigators want to examine if the financial and emotional burden decreases as the child gets older by comparing the financial and emotional impact of the different ages of children/young adults included. For this purpose, the results on the questionnaires of the 3 age groups will be compared.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Financial burden; Questionnaires; Interviews; Cleft lip and palate; Perceptions; Emotional burden
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Cleft Lip; Cleft Palate
• Other Study ID Numbers: ONZ-2024-0282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No