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Babble Boot Camp for Speech and Language Disorders in Galactosemia

N/A

Waitlist Available

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newborn diagnosis of classic galactosemia

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 4 years 2 months

Awards & highlights

Study Summary

This trial is investigating whether the Babble Boot Camp is more effective than standard care regarding speech and language outcomes in children with CG. If this proactive intervention is more effective than standard care, this will change their clinical management from deficit-based to proactive services.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, traditional side effects associated with medications are not expected. However, there may be varying levels of engagement or stress in parents and children participating in the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn was diagnosed with classic galactosemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 4 years 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 4 years 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 years 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expressive language skills

Speech sound production accuracy

Secondary outcome measures

Child health and development using the Ages and Stages Questionnaires 3

Cognitive development

Quality of life using the PedsQL questionnaires

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Treatment cohort with classic galactosemia, delayed startExperimental Treatment1 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 galactosemiaExperimental Treatment1 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 galactosemiaActive Control1 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 controlsActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington State UniversityOTHER

101 Previous Clinical Trials

56,405 Total Patients Enrolled

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,205 Total Patients Enrolled

Media Library

Babble Boot Camp Clinical Trial Eligibility Overview. Trial Name: NCT03838016 — N/A

Galactosemia Research Study Groups: Treatment cohort with classic galactosemia, Older control cohort with classic galactosemia, Typical controls, Treatment cohort with classic galactosemia, delayed start

Galactosemia Clinical Trial 2023: Babble Boot Camp Highlights & Side Effects. Trial Name: NCT03838016 — N/A

Babble Boot Camp 2023 Treatment Timeline for Medical Study. Trial Name: NCT03838016 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participation in this research study presently?

"Affirmative. The clinical trial is actively seeking out participants, as evidenced by the information present on clinicaltrials.gov. This experiment was inaugurated on May 1st 2019 and modified most recently in February 15th 2022. As of now, 309 individuals are needed to complete this research located at a single medical centre."

Answered by AI

What is the current participant capacity for this research initiative?

"Affirmative. Clinicaltrials.gov records point to the fact that this study, which commenced on May 1st 2019, is actively recruiting participants. The research requires 309 patients from a single medical centre."

Answered by AI

Is participation in this research endeavor accessible to me?

"This galactosemia trial seeks 309 participants aged between two and 54 months. To be considered, one parent must possess a rudimentary education, access to technology and the internet (assistance is available if necessary) with no restrictions on race or location due to digital delivery of treatment intervention."

Answered by AI

Does this medical research trial permit persons of advanced age to participate?

"Patients aged two to fifty-four months are eligible for inclusion in this clinical trial. Additionally, there is a separate cohort of 260 trials specifically targeting minors and another group of 627 trials created for patients over the age of sixty-five."

Answered by AI