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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

No Placebo-Only Group

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

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I have Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am waiting for heart surgery.

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I was born before reaching 34 weeks of pregnancy.

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I have a form of Down syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this milestone may occur at any point through the 10 months of intervention, or not at all.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Age at first words

Child utterance complexity

Linguistic environment

+2 more

Secondary study objectives

Consonant and vowel inventory

Parenting Stress Index 4 Short Form

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met