Cleft Lip and Cleft PalateNCT06905678
The Financial and Emotional Impact of Cleft Palate
An observational study of Cleft Lip and Cleft Palate, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 22 years
- Conditions the study is for
- Cleft Lip and Cleft Palate
- What is being tested?
- Questionnaires and Semi-structured interviews
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2025to Dec 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Presence of a cleft (lip and) palate
- Age of 5, 12 or 18 years
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Kristiane Van Lierde, +32 9 332 01 43, kristiane.vanlierde@uzgent.be
Tara Mouton, +32 9 332 01 43, tara.mouton@ugent.be
About this study
Official title: 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.
- Conditions
- Cleft Lip and Cleft Palate
- Being tested
- Questionnaires, Semi-structured interviews
- Keywords
- Cleft lip and palate, Emotional burden, Financial burden, Questionnaires, Perceptions, Interviews
- Medical subject headings
- Cleft Lip, Cleft Palate, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
The participants will fin in questionnaires about the financial and emotional burden they experience.
Semi-structured interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and Cleft PalateStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905678
- Sponsor's protocol ID
- ONZ-2024-0282
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Financial and Emotional Impact of Cleft Palate on Children and Their Caregivers: a Mixed-method Study
- ClinicalTrials.gov ID
- NCT06905678
- Acronym / sponsor ID
- ONZ-2024-0282
- Conditions
- Cleft Lip and Cleft Palate
- Keywords
- Cleft lip and palate, Emotional burden, Financial burden, Questionnaires, Perceptions, Interviews
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Apr 2025 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children/young adults with cleft lip and/or palate | – | Other: Questionnaires, Other: Semi-structured interviewsThis group are children and young adults with a cleft lip and/or a cleft palate. They are 5, 12 or 22 years old. |
| Children/young adults without a cleft | – | Other: QuestionnairesThis 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. |
Who may qualify
- Ages
- 4 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Presence of a cleft (lip and) palate
- Age of 5, 12 or 18 years
Key exclusion criteria (1 listed)
- No specific exclusion criteria
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 |
|---|---|---|
| QuestionnairesThe participants will fin in questionnaires about the financial and emotional burden they experience. | Other | Children/young adults with cleft lip and/or palate, Children/young adults without a cleft |
| Semi-structured interviewsAfter the participants have filled in the questionnaires they will get the chance to participate in an interview to talk about their perceptions and experiences. | Other | Children/young adults with cleft lip and/or palate |
Primary outcome
Financial burden of a cleft
Time frame: 2 months
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.
Emotional burden of a cleft
Time frame: 2 months
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Cleft Lip and Cleft Palate, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Apr 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tara Mouton (+32 496 44 63 08, tara.mouton@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial burden of a cleft (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.