Cleft Lip and PalateNCT07781566
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
An observational study of Cleft Lip and Palate and Cleft Palate Children, run by University Ghent at 1 site in Belgium.
Trial summary
A cleft (lip and) palate is the most common congenital abnormality of the face and skull 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 years and older
- Conditions the study is for
- Cleft Lip and Palate, Cleft Palate Children, Speech Therapy
- What is being tested?
- High-intensity speech therapy for children with cleft palate and Low-intensity speech therapy for children with cleft palate
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2025to Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of children with cleft palate who participated in the associated randomized clinical trial evaluating high- and low-intensity speech therapy, their parents/caregivers, and the speech-language pathologists who provided the intervention. Participants will be selected from children and families enrolled in the clinical trial and from the speech-language pathologists providing the trial interventions.
Who may be able to join
- Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
- Aged between 4 and 12 years,
- Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
Who cannot join
- Children with syndromic clefts
- Oronasal fistula
- Velopharyngeal insufficiency
- Hearing disabilities based on pure tone audiometry (>25 dB HL)
- Cognitive and/or related learning disabilities or neuromuscular disorders
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
University Hospital Ghent
Ghent, East-Flanders, 9000
Kristiane Van Lierde, +3293320530, hiruz.ctu@uzgent.be
About this study
Official title: High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Parents and Speech-language Pathologists
A cleft (lip and) palate is the most common congenital abnormality of the face and skull 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. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with a cleft (lip and) palate based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with a cleft (lip and) palate and their parents). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with a cleft (lip and) palate. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.
Read the detailed description
Objective:
This study will investigate the effect of high-intensity therapy through a large-scale study. The aim is to compare high- and low-intensity speech and language therapy for children with a cleft (lip and) palate, based on the perceptions and experiences of the intervention providers (speech and language therapists in primary healthcare) and recipients (children with a cleft (lip and) palate and their parents).
Hypothesis:
Qualitative studies do not start from the researcher's perspective, but from that of the participant. Consequently, no direct hypotheses are formulated. Nevertheless, a hypothesis is put forward based on previous qualitative studies by the research team. We hypothesise that a high-intensity speech intervention will result in more positive experiences and will be considered more acceptable by both the healthcare providers and the recipients of the intervention. This assumption is based on the expectation that an intensive intervention can reduce fatigue, dropout and the emotional burden of therapy, increase intrinsic motivation to participate in therapy, and improve articulation and speech intelligibility in the short term.
- Conditions
- Cleft Lip and Palate, Cleft Palate Children, Speech Therapy, Speech Disorders in Children, Intervention Intensity
- Being tested
- High-intensity speech therapy for children with cleft palate, Low-intensity speech therapy for children with cleft palate
- Keywords
- Qualitative research, Speech therapy, Intervention Intensity, Cleft lip and palate
- Medical subject headings
- Cleft Lip, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity speech therapy for children with cleft palateBehavioural
High-intensity speech therapy consisted of five 30-minute speech therapy sessions per week over two separate 2-week periods, with a 6-week rest period between the two periods. The intervention comprised a total of 10 hours of speech therapy.
Low-intensity speech therapy for children with cleft palateBehavioural
Low-intensity speech therapy consisted of two 30-minute speech therapy sessions per week over a 10-week period. The intervention comprised a total of 10 hours of speech therapy.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity speech therapy (HISI) | Participants who received high-intensity speech therapy, consisting of five 30-minute sessions per week during two separate 2-week intervention periods, with a 6-week rest period between intervention periods. Receives: Behavioral: High-intensity speech therapy for children with cleft palate | |
| Low-intensity speech therapy (LISI) | Participants who received low-intensity speech therapy, consisting of two 30-minute sessions per week over a 10-week intervention period. Receives: Behavioral: Low-intensity speech therapy for children with cleft palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived acceptability of high- and low-intensity speech intervention
Perceptions and experiences of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the acceptability of high-intensity and low-intensity speech therapy. Acceptability will be explored through semi-structured interviews and examined across the seven constructs of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Qualitative thematic analysis will be used to identify perceptions, experiences, and factors influencing acceptability of the two treatment intensities.
Measured: Day 1
Secondary outcomes (4)
Perceived feasibility and burden of high- and low-intensity speech therapy
Perceptions of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the practical feasibility and burden associated with high- and low-intensity speech therapy. This includes experiences related to treatment frequency and duration, travel, scheduling, school and family commitments, fatigue, and other competing demands. Data will be collected through semi-structured interviews and analysed qualitatively.
Measured: Day 1
Perceived therapeutic value of high- and low-intensity speech therapy
Perceptions of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the therapeutic value and perceived effectiveness of high- and low-intensity speech therapy. This includes perceptions of speech progress, continuity, repetition, intensity, and the extent to which the intervention supports speech development. Data will be collected through semi-structured interviews and analysed qualitatively.
Measured: Day 1
Emotional and motivational experiences of high- and low-intensity speech therapy
Emotional and motivational experiences of children with cleft palate, their parents/caregivers, and speech-language pathologists during high- and low-intensity speech therapy. This includes experiences of enjoyment, motivation, fatigue, frustration, and other emotional responses to the intervention. Data will be collected through semi-structured interviews and analysed qualitatively.
Measured: Day 1
Treatment preferences and contextual factors influencing acceptability of speech therapy intensity
Preferences of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding high- and low-intensity speech therapy, and contextual factors influencing these preferences. Factors related to the child, family, therapist, treatment setting, scheduling, and everyday circumstances will be explored. Data will be collected through semi-structured interviews and analysed qualitatively to identify factors that facilitate or hinder acceptance of different treatment intensities.
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 posted24 Aug 2026
- Study start1 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Kristiane Van Lierde, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781566
- Sponsor's protocol ID
- ONZ-2024-0191
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alighieri C, Bettens K, Verbeke J, Van Lierde K. 'Sometimes I feel sad': A qualitative study on children's perceptions with cleft palate speech and language therapy. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1526-1538. doi: 10.1111/1460-6984.12879. Epub 2023 Apr 18.
PubMed 37072901Alighieri C, Bettens K, Verhaeghe S, Van Lierde K. Speech diagnosis and intervention in children with a repaired cleft palate: A qualitative study of Flemish private community speech-language pathologists' practices. Int J Speech Lang Pathol. 2022 Feb;24(1):53-66. doi: 10.1080/17549507.2021.1946153. Epub 2021 Jul 6.
PubMed 34229538Alighieri C, Peersman W, Bettens K, Van Herreweghe V, Van Lierde K. Parental perceptions and expectations concerning speech therapy-related cleft care - a qualitative study. J Commun Disord. 2020 Sep-Oct;87:106028. doi: 10.1016/j.jcomdis.2020.106028. Epub 2020 Jul 3.
PubMed 32659479Alighieri C, Van Lierde K, Cammu H, Vanoost L, Bettens K. The retrospective acceptability of high intensity versus low intensity speech intervention in children with a cleft palate: A qualitative study from the parents' point of view using the Theoretical Framework of Acceptability. Int J Lang Commun Disord. 2023 Mar;58(2):326-341. doi: 10.1111/1460-6984.12788. Epub 2022 Oct 3.
PubMed 36189983Alighieri C, Bettens K, Vanoost L, Demuynck K, Verhaeghe S, Van Lierde K. Parents' perceptions on speech therapy delivery models in children with a cleft palate: A mixed methods study. Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110958. doi: 10.1016/j.ijporl.2021.110958. Epub 2021 Oct 27.
PubMed 34736010Alighieri C, Bettens K, Verhaeghe S, Van Lierde K. From excitement to self-doubt and insecurity: Speech-language pathologists' perceptions and experiences when treating children with a cleft palate. Int J Lang Commun Disord. 2021 Jul;56(4):739-753. doi: 10.1111/1460-6984.12624. Epub 2021 May 28.
PubMed 34048135
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Parents and Speech-language Pathologists
- ClinicalTrials.gov ID
- NCT07781566
- Acronym / sponsor ID
- ONZ-2024-0191
- Conditions
- Cleft Lip and Palate, Cleft Palate Children, Speech Therapy, Speech Disorders in Children, Intervention Intensity
- Keywords
- Qualitative research, Speech therapy, Intervention Intensity, Cleft lip and palate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Aug 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.
A cleft (lip and) palate is the most common congenital abnormality of the face and skull 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. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with a cleft (lip and) palate based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with a cleft (lip and) palate and their parents). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with a cleft (lip and) palate. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.
Detailed description
Objective:
This study will investigate the effect of high-intensity therapy through a large-scale study. The aim is to compare high- and low-intensity speech and language therapy for children with a cleft (lip and) palate, based on the perceptions and experiences of the intervention providers (speech and language therapists in primary healthcare) and recipients (children with a cleft (lip and) palate and their parents).
Hypothesis:
Qualitative studies do not start from the researcher's perspective, but from that of the participant. Consequently, no direct hypotheses are formulated. Nevertheless, a hypothesis is put forward based on previous qualitative studies by the research team. We hypothesise that a high-intensity speech intervention will result in more positive experiences and will be considered more acceptable by both the healthcare providers and the recipients of the intervention. This assumption is based on the expectation that an intensive intervention can reduce fatigue, dropout and the emotional burden of therapy, increase intrinsic motivation to participate in therapy, and improve articulation and speech intelligibility in the short term.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity speech therapy (HISI) | – | Behavioral: High-intensity speech therapy for children with cleft palateParticipants who received high-intensity speech therapy, consisting of five 30-minute sessions per week during two separate 2-week intervention periods, with a 6-week rest period between intervention periods. |
| Low-intensity speech therapy (LISI) | – | Behavioral: Low-intensity speech therapy for children with cleft palateParticipants who received low-intensity speech therapy, consisting of two 30-minute sessions per week over a 10-week intervention period. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of children with cleft palate who participated in the associated randomized clinical trial evaluating high- and low-intensity speech therapy, their parents/caregivers, and the speech-language pathologists who provided the intervention. Participants will be selected from children and families enrolled in the clinical trial and from the speech-language pathologists providing the trial interventions.
Key inclusion criteria (3 listed)
- Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
- Aged between 4 and 12 years,
- Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
Key exclusion criteria (5 listed)
- Children with syndromic clefts
- Oronasal fistula
- Velopharyngeal insufficiency
- Hearing disabilities based on pure tone audiometry (>25 dB HL)
- Cognitive and/or related learning disabilities or neuromuscular disorders
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 |
|---|---|---|
| High-intensity speech therapy for children with cleft palateHigh-intensity speech therapy consisted of five 30-minute speech therapy sessions per week over two separate 2-week periods, with a 6-week rest period between the two periods. The intervention comprised a total of 10 hours of speech therapy. | Behavioural | High-intensity speech therapy (HISI) |
| Low-intensity speech therapy for children with cleft palateLow-intensity speech therapy consisted of two 30-minute speech therapy sessions per week over a 10-week period. The intervention comprised a total of 10 hours of speech therapy. | Behavioural | Low-intensity speech therapy (LISI) |
Primary outcome
Perceived acceptability of high- and low-intensity speech intervention
Time frame: Day 1
Perceptions and experiences of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the acceptability of high-intensity and low-intensity speech therapy. Acceptability will be explored through semi-structured interviews and examined across the seven constructs of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Qualitative thematic analysis will be used to identify perceptions, experiences, and factors influencing acceptability of the two treatment intensities.
4 secondary outcomes
Perceived feasibility and burden of high- and low-intensity speech therapy
Time frame: Day 1
Perceived therapeutic value of high- and low-intensity speech therapy
Time frame: Day 1
Emotional and motivational experiences of high- and low-intensity speech therapy
Time frame: Day 1
Treatment preferences and contextual factors influencing acceptability of speech therapy intensity
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 24 Aug 2026.
- Background: PubMed 37072901Alighieri C, Bettens K, Verbeke J, Van Lierde K. 'Sometimes I feel sad': A qualitative study on children's perceptions with cleft palate speech and language therapy. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1526-1538. doi: 10.1111/1460-6984.12879. Epub 2023 Apr 18.
- Background: PubMed 34229538Alighieri C, Bettens K, Verhaeghe S, Van Lierde K. Speech diagnosis and intervention in children with a repaired cleft palate: A qualitative study of Flemish private community speech-language pathologists' practices. Int J Speech Lang Pathol. 2022 Feb;24(1):53-66. doi: 10.1080/17549507.2021.1946153. Epub 2021 Jul 6.
- Background: PubMed 32659479Alighieri C, Peersman W, Bettens K, Van Herreweghe V, Van Lierde K. Parental perceptions and expectations concerning speech therapy-related cleft care - a qualitative study. J Commun Disord. 2020 Sep-Oct;87:106028. doi: 10.1016/j.jcomdis.2020.106028. Epub 2020 Jul 3.
- Background: PubMed 36189983Alighieri C, Van Lierde K, Cammu H, Vanoost L, Bettens K. The retrospective acceptability of high intensity versus low intensity speech intervention in children with a cleft palate: A qualitative study from the parents' point of view using the Theoretical Framework of Acceptability. Int J Lang Commun Disord. 2023 Mar;58(2):326-341. doi: 10.1111/1460-6984.12788. Epub 2022 Oct 3.
- Background: PubMed 34736010Alighieri C, Bettens K, Vanoost L, Demuynck K, Verhaeghe S, Van Lierde K. Parents' perceptions on speech therapy delivery models in children with a cleft palate: A mixed methods study. Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110958. doi: 10.1016/j.ijporl.2021.110958. Epub 2021 Oct 27.
- Background: PubMed 34048135Alighieri C, Bettens K, Verhaeghe S, Van Lierde K. From excitement to self-doubt and insecurity: Speech-language pathologists' perceptions and experiences when treating children with a cleft palate. Int J Lang Commun Disord. 2021 Jul;56(4):739-753. doi: 10.1111/1460-6984.12624. Epub 2021 May 28.
- 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.
Kristiane Van Lierde, Professor principal investigator
University Ghent
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 Palate and Cleft Palate Children, run by University 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 3 inclusion and 5 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 24 Aug 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 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 (+32496446308, tara.mouton@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived acceptability of high- and low-intensity speech intervention (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781566, which also lists 6 linked publications.
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 24 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.