Actively Recruiting

Phase Not Applicable
Age: 4Years - 12Years
All Genders
ID06105099

One Size Does Not Fit All: Performance-specific Speech Therapy and Long-term Learning in Children With a Cleft Palate

Led by University Ghent · Updated on 2023-10-27

135

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Ghent

Lead Sponsor

R

Research Foundation Flanders

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the best speech therapy approaches for children aged 4 to 12 years old who have a cleft palate with or without a cleft lip and show specific compensatory speech characteristics. The study aims to compare three types of speech therapy methods to find the most effective treatment for improving speech and quality of life in Belgian Dutch-speaking children. Additionally, the research looks at how well these speech improvements last over time and whether new speech skills transfer to other sounds. The trial compares three speech therapy methods: a motor-phonetic approach focusing on phoneme-by-phoneme articulation, a phonological approach emphasizing sound contrasts and self-monitoring, and a combined phonetic-phonological approach targeting multiple errors within meaningful language contexts. Children will receive one of these therapies tailored to their specific type of compensatory speech characteristic, categorized as anterior oral, posterior oral, or non-oral. Therapy progresses through defined steps depending on the approach and child performance. Participants will be assessed at multiple times: immediately before therapy, immediately after, and at 1, 3, and 6 months post-intervention. Assessments include measuring consonant proficiency, how understandable the child's speech is in context, and health-related quality of life. The study is randomized and double-blinded to compare effects fairly. The total participation duration includes therapy and follow-up assessments to evaluate both short-term and long-term learning and retention of speech improvements.

CONDITIONS

Brief Title

Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate

Who Can Participate

Age: 4Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 confirmed by a speech-language pathologist
Not Eligible

You will not qualify if you...

  • Children with syndromic clefts
  • Presence of oronasal fistula
  • Velopharyngeal insufficiency
  • Hearing disabilities with hearing loss greater than 25 dB HL
  • Cognitive, learning disabilities, or neuromuscular disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration varies according to therapy progression and participant response

Participants receive one of three speech therapy approaches targeting cleft speech characteristics: motor-phonetic intervention, phonological intervention, or combined phonetic-phonological intervention.

Multiple therapy sessions scheduled as determined by therapists

Follow-up

Duration - 6 months post-intervention

Participants are assessed for speech proficiency and health-related quality of life immediately after therapy and at 1, 3, and 6 months post-intervention to measure short-term and long-term learning effects.

4 assessment visits (immediately post-intervention, 1 month, 3 months, and 6 months post-intervention)

Trial Site Locations

Total: 1 location

1

Department of Rehabilitation Sciences

Ghent, Belgium, 9000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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