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

NCT07781566 | Recruiting DMC

• 1 other identifier: ONZ-2024-0191
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (4)

• Perceived feasibility and burden of high- and low-intensity speech therapy

  Day 1

• Perceived therapeutic value of high- and low-intensity speech therapy

  Day 1

• Emotional and motivational experiences of high- and low-intensity speech therapy

  Day 1

• Treatment preferences and contextual factors influencing acceptability of speech therapy intensity

  Day 1

Study Arms (2)

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.

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.

Behavioral: Low-intensity speech therapy for children with cleft palate

Interventions

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.

High-intensity speech therapy (HISI)

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.

Low-intensity speech therapy (LISI)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Related Publications (6)

• 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.

  PMID: 37072901 BACKGROUND

• Alighieri 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.

  PMID: 34229538 BACKGROUND

• Alighieri 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.

  PMID: 32659479 BACKGROUND

• Alighieri 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.

  PMID: 36189983 BACKGROUND

• Alighieri 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.

  PMID: 34736010 BACKGROUND

• Alighieri 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.

  PMID: 34048135 BACKGROUND

MeSH Terms

Conditions

Cleft Lip; Communication Disorders

Interventions

cyclopropapyrroloindole

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kristiane Van Lierde, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Mouton

CONTACT

+32496446308; tara.mouton@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 24, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)