Babble Boot Camp for Down Syndrome

(BBC-DS Trial)

Overseen By Beate Peter, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Disqualifiers: Partial trisomy 21, Awaiting heart surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Babble Boot Camp, designed to help infants with Down syndrome improve their speech and language skills early on. The study will evaluate the effectiveness of two approaches: weekly individual sessions and monthly group sessions. Families may join if their child has full trisomy 21 (a form of Down syndrome) and English is the main language at home. This proactive approach aims to support speech and language development before bigger challenges arise. As an unphased trial, the study offers families the chance to contribute to innovative research that could shape future therapies for children with Down syndrome.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for children with Down syndrome?

Research shows that Babble Boot Camp (BBC) is a program designed to assist infants who might face speech and language challenges, such as those with Down syndrome. While detailed safety data specifically for Babble Boot Camp is not available, tests with children with Down syndrome have reported no problems. The program includes activities led by parents to enhance speech and language skills.

Speech pathologists guide parents in using everyday activities, making the approach non-invasive and free of medical procedures. This design ensures it is generally safe and easy for families to implement. The program resembles others used for different conditions and has shown promise without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Babble Boot Camp because it offers a personalized approach to improving speech and language skills in children with Down syndrome. Unlike traditional speech therapy, which often follows a set curriculum, the "Individual intervention" arm delivers one-on-one coaching tailored to each child's unique abilities, allowing for more targeted skill development. The "Group intervention" arm empowers caregivers by equipping them with practical strategies they can implement at home, fostering a supportive and interactive learning environment. This dual approach not only enhances the effectiveness of speech therapy but also actively involves parents in their child's progress, potentially leading to more significant and lasting improvements.

What evidence suggests that this trial's treatments could be effective for Down syndrome?

Research has shown that Babble Boot Camp (BBC) could improve speech and language in children with Down syndrome (DS). Parents of young children who have participated have provided positive feedback, and early signs indicate it aids speech development. Although specific data on its effectiveness for children with DS is limited, similar programs have succeeded with children with classic galactosemia, a condition that also causes speech delays. In this trial, participants will be assigned to one of two arms: the Individual intervention arm, where a speech-language expert teaches parents to incorporate speech-enhancing activities into daily life during weekly sessions, or the Group intervention arm, where caregivers attend monthly group sessions to learn strategies for home use. Early indications suggest this hands-on approach might strengthen language skills in babies with DS. ^{2 6 7 8 9}

Who Is on the Research Team?

Beate Peter

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English is the primary language spoken in my home.

I have Down syndrome.

Exclusion Criteria

Any additional condition that could confound the findings

I am waiting for heart surgery.

I was born before reaching 34 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a proactive speech and language intervention via telehealth, with weekly individualized sessions or monthly group sessions for 10 months

10 months

Weekly or monthly telehealth sessions

Follow-up

Participants are monitored for speech and language development outcomes and parental well-being

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Babble Boot Camp

Trial Overview 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.

How Is the Trial Designed?

Group I: Individual intervention Experimental Treatment 1 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 intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

American Speech-Language-Hearing Foundation

Collaborator

Trials

2

Recruited

90+

American Speech-Language-Hearing Foundation

Collaborator

Trials

2

Recruited

90+

Published Research Related to This Trial

Physical activity offers numerous benefits for children, including enjoyment, social interaction, health maintenance, and a sense of achievement.

For children with Down syndrome, establishing a strong foundation for physical activity early on is crucial for maintaining an active lifestyle throughout school and into adulthood, highlighting the need for increased support from professionals for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing opportunities for physical activity. Buckley, S.[2016]

Treadmill training is feasible for infants at high risk for neuromotor dysfunction, as demonstrated in a case report of a male infant who began training at 5 months corrected age after experiencing a grade III intraventricular hemorrhage.

The treadmill training led to stepping patterns that were similar to those of typically developing infants, suggesting that it may promote more mature stepping characteristics despite the child's high-risk status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training for an infant born preterm with a grade III intraventricular hemorrhage. Bodkin, AW., Baxter, RS., Heriza, CB.[2009]

A total of 78,623 adverse event reports were analyzed from the FDA database, with serious outcomes occurring in 40% of children and 43% of adolescents, highlighting the significant risk associated with medications in these age groups.

Central nervous system stimulants and analgesics were the most commonly reported drugs in children, while adolescents reported more cases involving tumor necrosis factor blockers and atypical antipsychotics, indicating different medication safety profiles and adverse event types based on age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs associated with adverse events in children and adolescents. Lee, WJ., Lee, TA., Pickard, AS., et al.[2014]

A review of 21 studies on early interventions for infants and children with Down's syndrome showed consistent short-term improvements in fine motor skills, social skills, and developmental quotients (DQ/IQ), but mixed results in gross motor, language, and cognitive skills.

Long-term follow-up indicated that the initial gains from these interventions did not persist into the early years of primary schooling, suggesting a need for more effective and tailored intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregated early intervention effects for Down's syndrome persons: patterning and longevity of benefits. Gibson, D., Harris, A.[2019]

A group of 20 adolescents with Down's syndrome participated in a structured athletics training program twice a week, which began in January 1994, and underwent complete medical examinations before starting.

The program led to significant improvements in strength, speed, and endurance test scores, suggesting that such training can positively influence physical fitness and promote a more athletic body type in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of physical response after athletics training in adolescents with Down's syndrome. Perán, S., Gil, JL., Ruiz, F., et al.[2019]

In a study involving 17 children with Down syndrome over 8 weeks, the use of the computer-based phonics program GraphoGame showed limited overall benefits at the group level, but some individual children demonstrated improved word decoding skills.

The results suggest that while the program may not be universally effective, it can be beneficial for certain children with Down syndrome when their individual learning challenges are taken into account.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive computer-based phonics training in the educational setting of children with Down syndrome: An explorative study. Nakeva von Mentzer, C., Kalnak, N., Jennische, M.[2021]

Approximately 80% of drugs approved by the FDA in the last 30 years have been labeled with disclaimers for use in children, highlighting a significant gap in pediatric drug safety and efficacy studies.

Recent initiatives by the FDA and the National Institute of Child Health and Human Development aim to increase the number of drugs studied and labeled for children, potentially improving access to safe and effective medications for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of drug approval processes and regulation of medications for children. Kauffman, RE.[2019]

The FDA has implemented a Pediatric Study Plan (PSP) requirement for all new drugs to ensure that safety and efficacy data for pediatric patients is systematically collected, addressing a significant gap in drug approval processes.

Incentives for conducting pediatric clinical trials, such as marketing exclusivity and priority review vouchers, encourage pharmaceutical companies to study drugs in various pediatric age groups, ensuring that medications are safe and effective for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients. Tabor, E.[2020]

A review of 311 individual case safety reports (ICSRs) from the WHO database revealed that musculoskeletal disorders were the most common adverse drug reactions (ADRs) in children and adolescents taking statins, accounting for 27.3% of reported cases.

The study highlighted serious safety concerns, including 42.8% of reports being classified as 'serious' with 11 deaths primarily due to intentional overdoses in adolescents, indicating a need for increased monitoring and reporting of statin ADRs in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of statins in children and adolescents: a descriptive analysis from VigiBase, the WHO global database of individual case safety reports. Conte, C., Rousseau, V., Vert, C., et al.[2021]

Wobble board training significantly improved static balance in adolescents with Down syndrome, as indicated by a decrease in the center of pressure (COP) area after training.

The training was effective regardless of whether the participants had their eyes open or closed, suggesting that it enhances balance control mechanisms in these adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of wobble board training on the eyes open and closed static balance ability of adolescents with down syndrome. Park, TJ.[2021]

The DSFit exercise program, designed for adolescents with Down syndrome, was found to be feasible and engaging, with most participants showing improvements in physical fitness assessments after the intervention.

Feedback from participants and parents indicated high enjoyment and appreciation for the program, highlighting its potential to help develop sustainable exercise habits among adolescents with Down syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DSFit: a feasibility pilot study of a group exercise programme for adolescents with Down syndrome. Hojlo, MA., Milliken, AL., Baumer, NT., et al.[2023]

Out of 1787 reported adverse drug reactions (ADRs) over 11 years, 103 (5.85%) were in pediatric patients, with serious ADRs being more common in younger children, particularly newborns and infants.

The most frequent ADRs were nervous system disorders, primarily linked to antineoplastics and immunodulators, highlighting the need for careful monitoring and reporting, especially since medication errors were noted in 7.8% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital. López-Valverde, L., Domènech, È., Roguera, M., et al.[2021]

An abbreviated cognitive remediation programme was tested on 18 children aged 6-15 with neurological and attention issues, showing improvements in both parent-reported attention and children's performance on attention tasks.

The results suggest that this shorter version of the established programme could be an effective outpatient treatment for attention problems, but further research with control groups and longer follow-up is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study evaluating an abbreviated version of the cognitive remediation programme for youth with neurocognitive deficits. Luton, LM., Reed-Knight, B., Loiselle, K., et al.[2019]

A study involving 95 school-aged children with Down syndrome (mean age 10.9 years) highlighted that while they generally received appropriate multidisciplinary care, access to medical specialists and rehabilitation services was often challenging due to long waiting lists and limited availability.

Despite 94% of children under six being integrated into typical classes, by age 15, 75% were placed in medico-social institutions, indicating a shift in educational settings as they age, which may reflect the need for more tailored support as their needs evolve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care management in a French cohort with Down syndrome from the AnDDI-Rares/CNSA study. Roux-Levy, PH., Sanlaville, D., De Freminville, B., et al.[2021]

Citations

1. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-24-00271

Babble Boot Camp for Infants With Down Syndrome We piloted Babble Boot Camp (BBC), a proactive, parent-led speech and language intervention, with 10 children with DS ages 4–16 months.

2. down-syndrome.org down-syndrome.org/en-us/research/projects/babble-bootcamp-infants

Babble Boot Camp for infants with Down syndrome The children received 10 months of weekly Babble Boot Camp sessions. The results are promising in terms of parent feedback on acceptability and initial data on ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40153250/

Babble Boot Camp for Infants With Down Syndrome: Piloting a ... The purpose of the pilot study described here was to investigate feasibility and potential benefits of such an intervention toward a fully ...

4. sites.google.com sites.google.com/a/asu.edu/peterspeechlanguagegenetics/home/research/turning-knowledge-of-genetics-into-action-the-babble-boot-camp

Peter Lab at ASU - The Babble Boot Camp Down syndrome Pilot Study. The encouraging data trends in children with CG who received the speech/language intervention motivates the ...

5. withpower.com withpower.com/trial/phase-down-syndrome-1-2024-e4ab9

Babble Boot Camp for Down Syndrome (BBC-DS Trial) The available research does not provide specific data on the effectiveness of Babble Boot Camp for Down Syndrome. However, it does mention other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12083757/

Babble Boot Camp for Infants With Down Syndrome: Piloting a ... We piloted Babble Boot Camp (BBC), a proactive, parent-led speech and language intervention, with 10 children with DS ages 4–16 months. Each ...

7. pubs.asha.org pubs.asha.org/doi/10.1044/2021_AJSLP-21-00098

First Post-Intervention Results of Babble Boot Camp ... Babble Boot Camp (BBC) is a package of proactive activities and routines designed to prevent speech and language disorders in infants at predictable risk.

8. medicine.wsu.edu medicine.wsu.edu/news/2025/05/19/babble-boot-camp/

SHS's Babble Boot Camp Shows Promise for Children with ... SHS's Babble Boot Camp Shows Promise for Children with Down Syndrome ... Clinical trial testing showed nothing short of “spectacular” results ...

9. asha.figshare.com asha.figshare.com/articles/online_resource/Babble_Boot_Camp_for_infants_with_Down_syndrome_Peter_et_al_2025_/28655222

Babble Boot Camp for infants with Down syndrome (Peter et al ... Method: We piloted Babble Boot Camp (BBC), a proactive, parent-led ... BBC components can improve long-term outcomes for children with DS.