protocolSection identificationModule nctId: NCT06381713, orgStudyIdInfo id: ONZ-2024-0158, briefTitle: Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, collaborators name: Research Foundation Flanders, descriptionModule briefSummary: 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., conditionsModule conditions: Cleft Palate Children, conditions: Speech Therapy, conditions: Speech Disorders in Children, conditions: Cleft Lip and Palate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: High intensive combined phonetic-phonological intervention, interventions name: Low intensive combined phonetic-phonological intervention, outcomesModule primaryOutcomes measure: Consonant proficiency, primaryOutcomes measure: Incremental cost-utility ratio, primaryOutcomes measure: Incremental cost-effectiveness ratio, secondaryOutcomes measure: Intelligibility in Context, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Speech Function, secondaryOutcomes measure: Speech Distress, secondaryOutcomes measure: Communication attitudes of children aged 4 and 5 years, secondaryOutcomes measure: Communication attitudes of children aged 6 years and older, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False