Proactive speech and language intervention for infants with Down syndrome
Babble Boot Camp for Infants With Down Syndrome: Improving Speech and Language Outcomes Via a Proactive, Parent-led Intervention
This study tests a new program called Babble Boot Camp to see if it can help infants with Down syndrome improve their speech and language skills by training their caregivers to use fun activities at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 0 Months to 12 Months |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06450509 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to address the speech and language delays commonly experienced by infants with Down syndrome by implementing a proactive intervention known as Babble Boot Camp. The intervention, delivered via telehealth, trains caregivers to incorporate speech and language skill-building activities into their daily routines. The study will recruit 20 children with Down syndrome aged birth to 12 months and randomly assign them to one of two treatment groups to evaluate the effectiveness of this early intervention. By starting treatment in infancy, the goal is to build resilience against anticipated communication difficulties.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with full trisomy 21 who are less than 12 months old and primarily speak English at home.
Not a fit: Patients with partial or mosaic trisomy 21, those awaiting heart surgery, or born prematurely before 34 weeks gestation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve speech and language outcomes for infants with Down syndrome, enhancing their communication skills and overall quality of life.
How similar studies have performed: While proactive interventions for speech and language delays in infants with Down syndrome are relatively novel, similar approaches have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Full trisomy 21 * English is the main language spoken in the home Exclusion Criteria: * Partial or mosaic trisomy 21 * Any additional condition that could confound the findings * Awaiting heart surgery * Born prematurely before 34 weeks gestation
Where this trial is running
Tempe, Arizona
- Arizona State University — Tempe, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Beate Peter — Arizona State University
- Study coordinator: Beate Peter, Ph.D.
- Email: Beate.Peter@asu.edu
- Phone: 206 713 5839
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.