Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospital Ghent
RECRUITING
Ghent
Contact Information
Primary
Fien Allemeersch
Fien.Allemeersch@UGent.be
+32474128135
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2027-12
Participants
Target number of participants: 70
Treatments
Experimental: High intensive speech therapy
To investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a high-intensive speech intervention.
Active_comparator: Low intensive speech therapy
To investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a low-intensive speech intervention.
Related Therapeutic Areas
Sponsors
Leads: University Ghent
Collaborators: Research Foundation Flanders

This content was sourced from clinicaltrials.gov