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Clinical Trials/ISRCTN10540035
ISRCTN10540035Completed未知

In children with cleft palate speech disorder, is there a statistically significant difference in speech outcomes, activity and participation, when intervention is delivered by trained parents supported by connective health (PLAT), compared with routine care? A comparative study of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) versus routine speech therapy intervention for children with cleft palate speech disorders

Great Ormond Street Hospital for Children NHS Foundation Trust0 sites46 target enrollmentStarted: December 12, 2019Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Enrollment
46

Study Overview

Brief Summary

2020 Results article in https://doi.org/10.1111/1460-6984.12542 results (added 20/08/2020)

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • For children:
  • 1. Aged between 3 and 6.5 years
  • 2. Presenting with cleft palate with or without cleft lip at birth or velopharyngeal dysfunction, with or without a syndrome not associated with learning disability, with or without suspected velopharyngeal insufficiency
  • 3. Presenting with at least one cleft speech characteristic, with or without developmental speech errors
  • 4. Stimulable for at least one novel consonant
  • 5. Has age-appropriate attention and listening skills, behaviour and receptive and expressive language levels
  • 6. Fluent in English
  • For parents:
  • 7. Fluent in English,
  • 8. No diagnosed learning disability or mental health issues
  • 9. Able to commit the time to undertake the intervention for 12 weeks

Exclusion Criteria

  • For children:
  • 1. Has a syndrome with an associated learning disability
  • 2. Has a known neurological deficit
  • 3. Has behavioral problems
  • 4. Has a bilateral hearing loss of greater than 30 decibels
  • 5. Has a symptomatic fistula judged to affect articulation
  • 6. Velopharyngeal surgery planned within the following 4 months
  • 7. Presenting only with lateralisation/palatalisation or double articulation, or has no intra-oral air pressure on pressure consonants
  • For parents:
  • 8. Known learning disability or mental health issues
  • 9. Unable to make the time commitment

Investigators

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