The Financial and Emotional Impact of Cleft Palate

NCT06905678 | Recruiting

• 1 other identifier: ONZ-2024-0282
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Cleft Palate

Keywords

Cleft lip and palate; Emotional burden; Financial burden; Questionnaires; Perceptions; Interviews

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Differences in impact based on the type of cleft

  Through study completion, an average of 1 year

• Does the impact decrease as the child gets older

  Through study completion, an average of 1 year

Study Arms (2)

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; Other: Semi-structured interviews

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

Interventions

Questionnaires OTHER

The participants will fin in questionnaires about the financial and emotional burden they experience.

Children/young adults with cleft lip and/or palate; Children/young adults without a cleft

Semi-structured interviews OTHER

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 with cleft lip and/or palate

Eligibility Criteria

• Age: 4 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Financial Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Tara Mouton

CONTACT

+32 496 44 63 08; tara.mouton@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: April 1, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)