Babble Boot Camp for Speech and Language Disorders in Galactosemia

Overseen By Linda Eng, M.S.

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Arizona State University

Disqualifiers: Other galactosemia, Trisomy 21, deafness, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early intervention can enhance speech and language skills in infants with classic galactosemia (CG), a genetic condition that affects how the body processes the sugar galactose. The trial includes a program called Babble Boot Camp, which teaches parents how to support their children's early communication development, guided by a speech-language pathologist. It targets infants diagnosed with CG, aged 2 to 24 months, whose families speak English and have internet access. The trial will compare the outcomes of these interventions with standard care to assess whether proactive treatment offers more benefits. As an Early Phase 1 trial, this research focuses on understanding how the Babble Boot Camp program functions in infants, providing families an opportunity to explore this innovative approach.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that the Babble Boot Camp is safe for infants with classic galactosemia?

Research has shown that the Babble Boot Camp is designed to help prevent speech and language problems in young children at risk, such as those with classic galactosemia. Studies have found that most children who participated in the program were doing well by age 2 1/2 and did not require additional speech therapy. This suggests that the program is generally safe and does not cause harm.

The Babble Boot Camp includes online meetings with a speech expert and training for parents, making it a non-invasive approach. It does not involve medications or surgeries, which typically raise more safety concerns. The program focuses on boosting early communication skills, like babbling and using first words, through fun activities and daily routines.

In summary, early findings suggest that the Babble Boot Camp is safe for children, with participants showing positive results and no reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Babble Boot Camp because it offers a fresh approach to tackling speech and language disorders in children with classic galactosemia. Unlike traditional methods that might focus primarily on speech therapy sessions, this intervention combines close monitoring with family involvement and regular progress updates, creating a holistic support system. Additionally, the program's structured schedule of audio recordings and formal testing aims to track developmental progress closely, providing valuable insights into each child's unique speech and language journey. By starting interventions early and engaging parents actively, Babble Boot Camp hopes to make a significant impact on developmental outcomes, offering a more comprehensive alternative to existing treatments.

What evidence suggests that the Babble Boot Camp is effective for speech and language disorders in galactosemia?

Research has shown that the Babble Boot Camp program, which participants in this trial may receive, might help prevent speech and language problems in infants at risk. Early results from small studies suggest that specific activities and routines can positively affect early communication skills. For instance, activities that encourage cooing and babbling may aid in developing first words and simple word combinations. The program includes training for parents to help them incorporate these activities into everyday life. While more research is needed, early evidence is promising for improving speech and language outcomes in children with classic galactosemia. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 2-24 months with classic galactosemia, from any ethnic or racial background and geographic region. Parents must speak English at home, have an 8th grade education level to complete questionnaires, and access to a computer with internet (assistance available). Children with other forms of galactosemia or conditions like Trisomy 21 or deafness are excluded.

Inclusion Criteria

Any geographic region in the US and other countries because the intervention is done online

At least one parent must have at least an 8th grade education to be able to fill out the questionnaires

Any ethnic or racial background

Exclusion Criteria

I do not have conditions like Down syndrome or deafness that could affect the study.

I have a type of galactosemia that is not the classic form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Babble Boot Camp intervention implemented by a pediatric speech-language pathologist via parent training, focusing on fostering communication skills in children with classic galactosemia.

22 months

Weekly online meetings with SLP

Follow-up

Participants receive professional speech/language assessments at ages 2 1/2, 3 1/2, and 4 1/2 years to monitor long-term outcomes.

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Babble Boot Camp

Trial Overview The Babble Boot Camp program is being tested on infants at risk for speech and language disorders due to classic galactosemia. It's an online intervention by speech-language pathologists through parent training aimed at improving early communication skills. Progress is monitored weekly until the child reaches age two.

How Is the Trial Designed?

Group I: Treatment cohort with classic galactosemia, delayed start Experimental Treatment 1 Intervention

The children in the control cohort enter the study when they are younger than 5 months old and participate in the close monitoring until they are 24 months old. They start getting the same treatment type and intensity as the treatment cohort but at a delayed age, when they turn 15 months.

Group II: Treatment cohort with classic galactosemia Experimental Treatment 1 Intervention

These children and their parents receive the Babble Boot Camp intervention and also participate in the close monitoring activities (progress reports that the speech-language pathologist generates during the online meeting with the family; monthly daylong audio recording; questionnaires that are sent out every three to six months; formal speech and language testing at ages 2 1/2, 3 1/2, and 4 1/2 years).

Group III: Older control cohort with classic galactosemia Active Control 1 Intervention

The children in the older control cohort are 6 months to 4 1/2 years old and provide standardized test results in the area of speech and language development at child ages 2 1/2, 3 1/2, and 4 1/2 years. They receive no treatment and no close monitoring. These families provide questionnaire information every three months until child age 24 months.

Group IV: Typical controls Active Control 1 Intervention

These children are free of any medical or developmental diagnosis. They enter the study at ages 2 to 5 months and provide close monitoring data until they are 24 months old, then they receive standardized speech and language testing at ages 2 1/2, 3 1/2, and 4 1/2 years, just like the treatment cohort, but the typical controls receive no treatment under this study.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Washington State University

Collaborator

Trials

114

Recruited

58,800+

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32566130/

Randomized Pilot Trial of the Babble Boot Camp in Infants ... We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03838016

Preventing Speech and Language Disorders in Children ... The Babble Boot Camp is an experimental study to investigate whether earliest and proactive activities and routines can positively influence the speech and ...

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

Babble Boot Camp for infants with Down syndrome This project is exploring the effectiveness of a proactive, systematic, and longitudinal speech and language, parent-led intervention supported by weekly speech ...

5. 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 The Babble Boot Camp was created in 2017. We provide an extensive program of activities and routines via parent training, starting when the infant is 2 months ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34665663/

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

7. news.wsu.edu news.wsu.edu/news/2024/07/16/wsus-babble-boot-camp-launches-national-training-for-providers/

WSU launches new online training for childhood speech and ... Babble Boot Camp is unique for intervening before children show signs of a delay—when they “babble” but don't yet talk. In the intervention, a ...

8. news.asu.edu news.asu.edu/20250814-health-and-medicine-novel-intervention-gives-hope-children-risk-speech-and-language

Novel intervention gives hope to children at risk for speech ... When tested at age 2 1/2, the vast majority of Babble Boot Camp participants were doing well and did not show a need for additional speech ...