← Back to Search

Behavioural Intervention

Babble Boot Camp for Down Syndrome (BBC-DS Trial)

N/A
Recruiting
Led By Beate Peter
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Full trisomy 21
Be younger than 18 years old
Must not have
Patient is awaiting heart surgery
Patient born prematurely before 34 weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this milestone may occur at any point through the 10 months of intervention, or not at all.
Awards & highlights

Summary

This trial aims to study a proactive speech and language intervention for infants with Down syndrome. Children with Down syndrome often face challenges with communication skills from an early age. The intervention, based on a program called

Who is the study for?
This trial is for infants with Down syndrome, from birth to 12 months old. It aims to test a proactive speech and language intervention called Babble Boot Camp (BBC). The goal is to help these children develop better communication skills early on.
What is being tested?
The study tests the effectiveness of BBC in improving babble, speech production, and receptive and expressive language in infants with Down syndrome. Participants are split into two groups: one receives weekly sessions; the other has monthly group meetings over ten months.
What are the potential side effects?
Since this trial involves educational interventions rather than medication, traditional side effects are not expected. However, there may be differences in individual responses to the therapy based on each child's unique needs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am waiting for heart surgery.
Select...
I was born before reaching 34 weeks of pregnancy.
Select...
I have a form of Down syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this milestone may occur at any point through the 10 months of intervention, or not at all.
This trial's timeline: 3 weeks for screening, Varies for treatment, and this milestone may occur at any point through the 10 months of intervention, or not at all. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Age at first words
Child utterance complexity
Linguistic environment
+2 more
Secondary outcome measures
Consonant and vowel inventory
Parenting Stress Index 4 Short Form

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Individual interventionExperimental Treatment1 Intervention
Individual families will meet weekly with a pediatric speech-language pathologist for approximately 20 minutes. The speech-language pathologist will coach parents in strategies designed to boost speech and language skills, individually tailored to the child's current skillset.
Group II: Group interventionActive Control1 Intervention
Caregivers will meet in monthly 1-hour group sessions with a pediatric speech-language pathologist. The speech-language pathologist will describe strategies that families can use at home to boost their child's speech and language skills.

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
294 Previous Clinical Trials
107,370 Total Patients Enrolled
American Speech-Language-Hearing FoundationUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
Beate PeterPrincipal InvestigatorArizona State University
~27 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top