Treatment for preschool children who stutter
Treatment for Preschool Age Children Who Stutter: A Randomised, Multicentre, Non-inferiority Parallel Group Pragmatic Trial With Mini-KIDS, the Social Cognitive Behaviour Therapy and the Lidcombe Program With 249 Children
This study tests three different treatments for preschool children who stutter to see which one helps them speak more fluently over 18 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 249 (estimated) |
| Ages | 24 Months to 78 Months |
| Sex | All |
| Sponsor | Thomas More University of Applied Sciences Academic / other |
| Locations | 1 site (Antwerpen, Belgie) |
| Trial ID | NCT05185726 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates three different treatment approaches for preschool-aged children who stutter, comparing their effectiveness in reducing stuttering over an 18-month period. The treatments include Mini-KIDS, which focuses on stuttering modification techniques, Social Cognitive Behaviour Therapy that addresses cognitive and emotional factors, and the Lidcombe Program, which provides verbal feedback on speech. The study involves 249 children and aims to determine the most effective method for managing stuttering in young children.
Who should consider this trial
Good fit: Ideal candidates for this study are preschool-aged children between 2 to 6.5 years who have been identified as stuttering by a Speech-Language Therapist.
Not a fit: Patients with syndromes such as Down Syndrome may not benefit from this study due to the specific eligibility criteria.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for preschool children who stutter, improving their communication skills and overall quality of life.
How similar studies have performed: Other studies have shown success with similar approaches to treating stuttering in children, indicating that this trial builds on established methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Preschool age children must * stutter (identified by the Speech-Language Therapist) * be aged between 2 - 6.5 years * have normal hearing reported by the parent(s) * have, if bilingual, a parent who speaks a language that the SLT understands and speaks to allow clear communication * have at least one parent agreeing to be intensively involved in treatment and knowing that s/he will implement treatment at home * have at least one parent who is willing and able to videorecord his/her child regularly Exclusion Criteria: - have a syndrome such as Down Syndrome.
Where this trial is running
Antwerpen, Belgie
- Sabine Van Eerdenbrugh — Antwerpen, Belgie, Belgium (Recruiting)
Study contacts
- Principal investigator: Sabine Van Eerdenbrugh, Dr — Thomas More
- Study coordinator: Sabine Van Eerdenbrugh, Dr
- Email: sabine.vaneerdenbrugh@thomasmore.be
- Phone: +3234324040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.