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NCT Number: NCT07781566

Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Cleft Palate Children Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intervention Intensity Lip Diseases Mental Disorders Mouth Abnormalities Mouth Diseases Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders in Children Speech Therapy Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location status: Recruiting

Location contact

Kristiane Van Lierde

CONTACT

[email protected]

+3293320530

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High-intensity speech therapy for children with cleft palate

Behavioral

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 palate

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perceived feasibility and burden of high- and low-intensity speech therapy

    Time frame: Day 1

    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.

  2. Perceived therapeutic value of high- and low-intensity speech therapy

    Time frame: Day 1

    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.

  3. Emotional and motivational experiences of high- and low-intensity speech therapy

    Time frame: Day 1

    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.

  4. Treatment preferences and contextual factors influencing acceptability of speech therapy intensity

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tara Mouton

CONTACT

[email protected]

+32496446308

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Research Foundation Flanders

Registry information

Official study title

High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Parents and Speech-language Pathologists

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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