Early Childhood CariesQUALIKIDSNCT07377240
Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (QUALIKIDS).
A study testing Interview in people with Early Childhood Caries, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Dental caries is the most common chronic disease in children, and its early form-Early Childhood Caries (ECC)-which particularly affects children under the age of six, represents a major public health problem worldwide. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2026to Jul 2028
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All parents of children under 6 years of age with CPE-S, consulting the specialized dental care unit as part of the Handiconsult ARA Ouest program for complete conservative oral rehabilitation under general anesthesia
- Verbal agreement from the participant to take part in the study and for audio recording
- Parents who understand and speak French.
Who cannot join
- Parents of children in foster care.
- Parents under judicial protection, guardianship, or conservatorship.
- Parents who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +334754963, promo_interne_drci@chu-clermontferrand.fr
Valérie Collado
About this study
Official title: Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (SECC): a Qualitative Approach (QUALIKIDS)
Dental caries is the most common chronic disease in children, and its early form-Early Childhood Caries (ECC)-which particularly affects children under the age of six, represents a major public health problem worldwide. This disease has a negative impact on the quality of life of affected children and their families, and leads to significant functional and developmental consequences. Moreover, due to their young age, these children require specialized care and adapted treatment procedures, particularly the use of general anesthesia (GA) for comprehensive oral rehabilitation.
This conservative therapeutic approach improves the quality of life and orofacial functions of the children concerned, particularly their masticatory ability. However, there remains a significant rate of caries recurrence within the year following treatment. This is largely due to the difficulty families face in changing the dietary habits that contribute to the disease, such as the frequent consumption of sugar-rich foods in all their forms. These families are often bio-psycho-socially vulnerable and have a low level of oral health literacy. They also tend to show lower adherence to preventive measures (oral hygiene practices and regular dental check-ups for children) as well as to the health education and therapeutic interventions proposed to them.
In order to stabilize dental caries in these children, prevent repeated procedures due to recurrent caries, and offer interventions tailored to their needs, it is essential to better understand why oral health behaviors are so difficult to change within these families. This study aims to adopt a qualitative approach to explore the obstacles and barriers to modifying etiological behaviors, particularly dietary behaviors, in families of young children with severe ECC treated under general anesthesia in the specialized care unit of Handiconsult ARA Ouest (CHU Estaing Clermont-Ferrand - CH Riom). Semi-structured, face-to-face interviews conducted with one or both parents will investigate the different dimensions of this issue. A subgroup analysis will compare the factors influencing the adoption of oral health-promoting habits in families of children with and without associated developmental disorders.
Read the detailed description
The recruitment of participating parents is carried out by one of the dental practitioners who sees families during preoperative consultations (specialized dental care unit of the Handiconsult ARA Ouest program, Estaing Clermont-Ferrand University Hospital, or Riom Hospital).
The investigator who welcomes the family on the first day invites the parents to participate in the study, provides oral and written information on the nature and conduct of the study, and answers any questions they may have. If the parent(s) express an interest in participating in the study, their non-opposition is recorded.
To help encourage open discussion, another investigator conducts the recorded interviews as described above. After seeing the parent off, the investigator also writes an interview report summarizing the general course and circumstances of the interview, a summary of the information obtained for each topic, the key points from the interview, the elements to be repeated or modified for the next interview with another parent, and the exchanges or information gathered after the end of the interview.
A verbatim transcript is produced by hand after the interview, while listening to the recording, ensuring that all identifying information (e.g., names, places, identity of the healthcare team) is removed. Only the interview number (in order) is noted on the verbatim transcript. These audio recordings are destroyed within 15 days of transcription.
Subsequently, as the transcriptions are completed, a thematic analysis by coding is carried out by two independent investigators with the assistance of the CROC scientific collaborator. The transcripts will first be read by each investigator. Qualitative data analysis will then be performed using a thematic framework derived from the literature and developed during the analysis process. Continuous data analysis will be used, and the study will be considered complete when saturation is reached, i.e., when no new concepts are recorded.
- Conditions
- Early Childhood Caries
- Being tested
- Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Semi-structured, face-to-face interviews
| Study group | Role | What they receive |
|---|---|---|
| Interview | Other | Not described Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and relative frequency of barriers to changing dietary behaviors that cause early childhood caries
Identification after analysis of comments collected during a semi-structured interview with one or both parents, for the various topics covered in the interview guide.
Measured: day 1
Secondary outcomes (10)
Changes in the family's daily life related to managing early tooth decay
Measured: day 1
The difficulties encountered by families in accessing appropriate oral health care
Measured: day 1
Parents' perceptions of the appropriateness of general anesthesia for their child's dental care and the associated risks
Measured: day 1
The type, frequency, and context of the child's consumption of sugary foods, particularly between meals.
Measured: day 1
Changes in eating habits implemented since the diagnosis of CPE and difficulties encountered
Measured: day 1
The frequency and quality of tooth brushing and other preventive measures in place since the diagnosis of CPE
Measured: day 1
Parents' intrinsic or extrinsic motivations for changing habits
Measured: day 1
Families' expectations regarding the role of healthcare professionals in managing the disease
Measured: day 1
Requests expressed in terms of resources or support
Measured: day 1
The nature of the support measures that could be appropriate to parents' requests.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start10 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Collado, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377240
- Sponsor's protocol ID
- RNI 2025 COLLADO
- Other IDs
- 2025-A02056-43
- Acronym
- QUALIKIDS
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (SECC): a Qualitative Approach (QUALIKIDS)
- ClinicalTrials.gov ID
- NCT07377240
- Acronym / sponsor ID
- QUALIKIDS / RNI 2025 COLLADO
- Conditions
- Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
Dental caries is the most common chronic disease in children, and its early form-Early Childhood Caries (ECC)-which particularly affects children under the age of six, represents a major public health problem worldwide. This disease has a negative impact on the quality of life of affected children and their families, and leads to significant functional and developmental consequences. Moreover, due to their young age, these children require specialized care and adapted treatment procedures, particularly the use of general anesthesia (GA) for comprehensive oral rehabilitation.
This conservative therapeutic approach improves the quality of life and orofacial functions of the children concerned, particularly their masticatory ability. However, there remains a significant rate of caries recurrence within the year following treatment. This is largely due to the difficulty families face in changing the dietary habits that contribute to the disease, such as the frequent consumption of sugar-rich foods in all their forms. These families are often bio-psycho-socially vulnerable and have a low level of oral health literacy. They also tend to show lower adherence to preventive measures (oral hygiene practices and regular dental check-ups for children) as well as to the health education and therapeutic interventions proposed to them.
In order to stabilize dental caries in these children, prevent repeated procedures due to recurrent caries, and offer interventions tailored to their needs, it is essential to better understand why oral health behaviors are so difficult to change within these families. This study aims to adopt a qualitative approach to explore the obstacles and barriers to modifying etiological behaviors, particularly dietary behaviors, in families of young children with severe ECC treated under general anesthesia in the specialized care unit of Handiconsult ARA Ouest (CHU Estaing Clermont-Ferrand - CH Riom). Semi-structured, face-to-face interviews conducted with one or both parents will investigate the different dimensions of this issue. A subgroup analysis will compare the factors influencing the adoption of oral health-promoting habits in families of children with and without associated developmental disorders.
Detailed description
The recruitment of participating parents is carried out by one of the dental practitioners who sees families during preoperative consultations (specialized dental care unit of the Handiconsult ARA Ouest program, Estaing Clermont-Ferrand University Hospital, or Riom Hospital).
The investigator who welcomes the family on the first day invites the parents to participate in the study, provides oral and written information on the nature and conduct of the study, and answers any questions they may have. If the parent(s) express an interest in participating in the study, their non-opposition is recorded.
To help encourage open discussion, another investigator conducts the recorded interviews as described above. After seeing the parent off, the investigator also writes an interview report summarizing the general course and circumstances of the interview, a summary of the information obtained for each topic, the key points from the interview, the elements to be repeated or modified for the next interview with another parent, and the exchanges or information gathered after the end of the interview.
A verbatim transcript is produced by hand after the interview, while listening to the recording, ensuring that all identifying information (e.g., names, places, identity of the healthcare team) is removed. Only the interview number (in order) is noted on the verbatim transcript. These audio recordings are destroyed within 15 days of transcription.
Subsequently, as the transcriptions are completed, a thematic analysis by coding is carried out by two independent investigators with the assistance of the CROC scientific collaborator. The transcripts will first be read by each investigator. Qualitative data analysis will then be performed using a thematic framework derived from the literature and developed during the analysis process. Continuous data analysis will be used, and the study will be considered complete when saturation is reached, i.e., when no new concepts are recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview | Other | Other: Interview |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All parents of children under 6 years of age with CPE-S, consulting the specialized dental care unit as part of the Handiconsult ARA Ouest program for complete conservative oral rehabilitation under general anesthesia
- Verbal agreement from the participant to take part in the study and for audio recording
- Parents who understand and speak French.
Key exclusion criteria (3 listed)
- Parents of children in foster care.
- Parents under judicial protection, guardianship, or conservatorship.
- Parents who refuse to participate in the study.
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 |
|---|---|---|
| InterviewSemi-structured, face-to-face interviews | Other | Interview |
Primary outcome
Nature and relative frequency of barriers to changing dietary behaviors that cause early childhood caries
Time frame: day 1
Identification after analysis of comments collected during a semi-structured interview with one or both parents, for the various topics covered in the interview guide.
10 secondary outcomes
Changes in the family's daily life related to managing early tooth decay
Time frame: day 1
The difficulties encountered by families in accessing appropriate oral health care
Time frame: day 1
Parents' perceptions of the appropriateness of general anesthesia for their child's dental care and the associated risks
Time frame: day 1
The type, frequency, and context of the child's consumption of sugary foods, particularly between meals.
Time frame: day 1
Changes in eating habits implemented since the diagnosis of CPE and difficulties encountered
Time frame: day 1
The frequency and quality of tooth brushing and other preventive measures in place since the diagnosis of CPE
Time frame: day 1
Parents' intrinsic or extrinsic motivations for changing habits
Time frame: day 1
Families' expectations regarding the role of healthcare professionals in managing the disease
Time frame: day 1
Requests expressed in terms of resources or support
Time frame: day 1
The nature of the support measures that could be appropriate to parents' requests.
Time frame: day 1
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 28 Jul 2026.
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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.
Valérie Collado principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview in people with Early Childhood Caries, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 3 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 28 Jul 2026. 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 France. 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 Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and relative frequency of barriers to changing dietary behaviors that cause early childhood caries (time frame: day 1). 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 28 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.