An observational study in Cleft Lip and Palate, Cleft Palate Children and Speech Therapy, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by University Ghent · Observational
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.
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 49 observational studies indexed under Cleft Lip.
Browse Cleft Lip studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: High-intensity speech therapy for children with cleft palate
Participants who received low-intensity speech therapy, consisting of two 30-minute sessions per week over a 10-week intervention period.
Behavioral: Low-intensity speech therapy for children with cleft palate
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 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.
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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Sep 2027, 30 months after the start.
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