Down SyndromeBBC-DSNCT06450509
Proactive Speech and Language Intervention for Infants With Down Syndrome
A study testing Babble Boot Camp in people with Down Syndrome, run by Arizona State University at 1 site in United States.
Trial summary
Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout… Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Babble Boot Camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full trisomy 21
- English is the main language spoken in the home
Who cannot join
- Partial or mosaic trisomy 21
- Any additional condition that could confound the findings
- Awaiting heart surgery
- Born prematurely before 34 weeks gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Babble Boot Camp for Infants With Down Syndrome: Improving Speech and Language Outcomes Via a Proactive, Parent-led Intervention
Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout adulthood. Because DS is diagnosed at or even before birth, these difficulties are predictable; yet despite this prognostic knowledge, systematic and sustained proactive interventions have not yet been developed: Most children with DS are not assessed and treated for speech and language delays until age 2 to 4 years. This presents an untapped opportunity space to conduct a clinical trial of a proactive intervention in earliest infancy with the goal of building resilience against the anticipated difficulties. The intervention trialed here is a modified version of Babble Boot Camp (BBC), a proactive speech and language intervention originally developed for young infants with classic galactosemia (CG) (NIH 5R01HD098253). CG is a metabolic disease that, similar to DS, is diagnosed at birth and poses risks for severe speech and language delays. BBC is implemented by a speech-language pathologist who, via telehealth, trains parents to incorporate skill-building activities and routines into their daily lives at home. For the present study, 20 children with DS age birth to 12 months will be recruited and randomized into two treatment arms. One group will receive weekly individualized parent sessions and close monitoring of the child's progress. The second group will receive the same content but at a lower intensity and dosage, via monthly parent group meetings. Both groups will receive their intervention for 10 months. Specific aims are to quantify benefits for babble, speech production, and receptive and expressive language and to investigate associations between conversational dynamics in child-adult interactions and the children's speech and language. Outcomes in speech and language skills will show relative feasibility and benefits for each of these treatment modalities and motivate a larger clinical trial, with the ultimate goal of changing the way infants with DS receive support in their speech and language development, from a deficit-based, remedial model to a proactive one.
Read the detailed description
Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout adulthood. Because DS is diagnosed at or even before birth, these difficulties are predictable; yet despite this prognostic knowledge, systematic and sustained proactive interventions have not yet been developed: Most children with DS are not assessed and treated for speech and language delays until age 2 to 4 years. This presents an untapped opportunity to conduct a clinical trial of a proactive intervention in earliest infancy with the goal of building resilience against the anticipated difficulties. The intervention trialed here is a modified version of Babble Boot Camp (BBC), a proactive speech and language intervention originally developed for young infants with classic galactosemia (CG) (NIH 5R01HD098253). CG is a metabolic disease that, similar to DS, is diagnosed at birth and poses risks for severe speech and language delays. BBC is implemented by a speech-language pathologist who, via telehealth, trains caregivers to incorporate skill-building activities and routines into their daily lives at home. For the present study, 20 children with DS age birth to 12 months will be recruited and randomized into one of two treatment arms. One group will receive weekly individualized caregiver sessions and close monitoring of the child's progress. The second group will receive the same content but at a lower intensity and dosage, via monthly caregiver group meetings. Both groups will receive their intervention for 10 months. At the beginning and end of the intervention, a set of data will be collected: At the beginning of the interventions, caregivers will be asked to complete an intake questionnaire with demographic information and information about the child's birth history, health history, and any services currently accessed. At the end of the intervention, caregivers will provide updates to this questionnaire and also a satisfaction survey. At pre and post, caregivers will provide three daylong audio recordings that will be analyzed for child utterance rates and conversational turns. For children age 6 months and up. these recordings will also be queried for segments with greatest numbers of child utterances, and these will be transcribed into International Phonetic Alphabet to obtain an objective measure of babble complexity, using the Mean Babbling Level, and, if sufficient numbers of meaningful utterances are found, an objective measure of word complexity using the Syllable Structure Level. At pre and post, questionnaires will be collected to appraise the children's general development and communication competence, using the Vineland Adaptive Behavior Scales 3. More detailed measures of early language skills, such as receptive and expressive vocabulary, will be obtained with the MacArthur-Bates Communicative Development Inventories -3. Age at emergence of first words will be recorded as a personal milestone for each child. Regarding parental well-being, the Parenting Stress Index 4 Short Form will be collected to obtain measures of stress originating in the parents themselves, in parent-child interactions, and in difficult child behaviors. This questionnaire also contains an estimate of whether or not parents are under-reporting their own personal stress. Specific aims are to quantify 1) benefits of each of the two interventions for babble and early speech sound production, 2) benefits of each of the two interventions for receptive and expressive language skills, and 3) associations between caregiver-child conversational dynamics during the intervention and child speech and language skill after the intervention. Outcomes in speech and language skills will show relative feasibility and benefits for each of these treatment modalities on children's speech and language development as well as parental well-being, and they will motivate a larger clinical trial, with the ultimate goal of changing the way infants with DS receive support in their speech and language development, from a deficit-based, remedial model to a proactive one.
- Conditions
- Down Syndrome
- Being tested
- Babble Boot Camp
- Keywords
- Speech development, Language development, Linguistic environment, Parental stress, Babble complexity
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babble Boot CampBehavioural
Caregivers are coached by a pediatric speech-language pathologist to implement activities and routines into their daily home lives with the intent to foster and boost their child's precursor and earliest speech and language skills. The intervention will be conducted entirely via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Individual intervention | Experimental | 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. Receives: Behavioral: Babble Boot Camp |
| Group intervention | Active comparator | 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. Receives: Behavioral: Babble Boot Camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linguistic environment
Families will provide a set of three day-long audio recordings. Using the day-long audio recordings, the investigators will obtain adult word counts, child utterance counts, and conversational turn rates.
Measured: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Child utterance complexity
Child utterance complexity will be based on the six day-long audio recordings that will be provided by the families in sets of three each. For children age 6 months and up, the investigators will mine the day-long audio recordings for those 5-minute segments with the highest numbers of child utterances. These utterances will be transcribed into the International Phonetic Alphabet. The utterances will be scored for phonetic complexity based on the consonant and vowel content. For babbled utterances, the investigators will compute the Mean Babbling Level (scores range from 1 to 3), and for meaningful utterances, the investigators will compute the Syllable Structure Level (scores range from 1 to 4). For both of these measures, higher scores reflect greater utterance complexity. Child utterance complexity will be based on the six day-long audio recordings that will be provided by the families in sets of three each at the beginning (baseline) and end (10 months later) of the intervention.
Measured: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
MacArthur-Bates Communicative Inventories 3: Comprehensive Parent
In this checklist-based questionnaires, caregivers provide information about their child's language skills, for instance how many words the child understands and how many words the child produces. Point scores are converted into percentiles, where higher numbers reflect better outcomes.
Measured: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Vineland Adaptive Behavior Scales 3: Comprehensive Parent/Caregiver Form
Parents complete this questionnaire. Areas included in it are Communication, Daily Living Skills, Socialization, and Motor Skills. Point scores from the questionnaire are converted into standard scores and percentiles, where higher numbers reflect better outcomes.
Measured: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Age at first words
For each child, the age at which she/he started to produce words is recorded.
Measured: This milestone may occur at any point through the 10 months of intervention, or not at all.
Secondary outcomes (2)
Consonant and vowel inventory
From the phonetic transcriptions of the day-long audio recordings, an inventory of consonant and vowel sounds will be made.
Measured: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Parenting Stress Index 4 Short Form
In three blocks of 12 questions each, parents report on their own personal stress, stress derived from stressful interactions with the child, and stress derived from the child's difficult behaviors. Raw scores are converted into percentiles. Higher percentiles indicate higher levels of perceived stress.
Measured: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start28 Feb 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating infants and their parents will be randomized into two different treatment modalities, either weekly individualized intervention sessions or monthly group sessions. Both groups will receive the intervention for a duration of 10 months. Note that in each family, the infant and both caregivers, where available, will be enrolled. In each treatment arm, there will be 10 infants and up to 20 caregivers, for a total of 20 infants and up to 40 caregivers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Speech-Language-Hearing Foundation
- Responsible party
- Principal investigator, Beate Peter, Arizona State University
- Investigators
- Beate Peter, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450509
- Sponsor's protocol ID
- STUDY00018407
- Acronym
- BBC-DS
- Status last verified
- Aug 2025
- First submitted
- 29 Feb 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified information will be shared.
Publications
Potter NL, VanDam M, Bruce L, Davis J, Eng L, Finestack L, Heinlen V, Scherer N, Schrock C, Seltzer R, Stoel-Gammon C, Thompson L, Peter B. Virtual Post-Intervention Speech and Language Assessment of Toddler and Preschool Participants in Babble Boot Camp. J Speech Lang Hear Res. 2024 Sep 26;67(9S):3327-3339. doi: 10.1044/2023_JSLHR-22-00687. Epub 2023 May 26.
PubMed 37235746Peter B, Bruce L, Finestack L, Dinu V, Wilson M, Klein-Seetharaman J, Lewis CR, Braden BB, Tang YY, Scherer N, VanDam M, Potter N. Precision Medicine as a New Frontier in Speech-Language Pathology: How Applying Insights From Behavior Genomics Can Improve Outcomes in Communication Disorders. Am J Speech Lang Pathol. 2023 Jul 10;32(4):1397-1412. doi: 10.1044/2023_AJSLP-22-00205. Epub 2023 May 5.
PubMed 37146603Finestack LH, Potter N, VanDam M, Davis J, Bruce L, Scherer N, Eng L, Peter B. Feasibility of a Proactive Parent-Implemented Communication Intervention Delivered via Telepractice for Children With Classic Galactosemia. Am J Speech Lang Pathol. 2022 Nov 16;31(6):2527-2538. doi: 10.1044/2022_AJSLP-22-00107. Epub 2022 Oct 14.
PubMed 36251874Peter B, Davis J, Finestack L, Stoel-Gammon C, VanDam M, Bruce L, Kim Y, Eng L, Cotter S, Landis E, Beames S, Scherer N, Knerr I, Williams D, Schrock C, Potter N. Translating principles of precision medicine into speech-language pathology: Clinical trial of a proactive speech and language intervention for infants with classic galactosemia. HGG Adv. 2022 May 20;3(3):100119. doi: 10.1016/j.xhgg.2022.100119. eCollection 2022 Jul 14.
PubMed 35677809Peter B, Davis J, Cotter S, Belter A, Williams E, Stumpf M, Bruce L, Eng L, Kim Y, Finestack L, Stoel-Gammon C, Williams D, Scherer N, VanDam M, Potter N. Toward Preventing Speech and Language Disorders of Known Genetic Origin: First Post-Intervention Results of Babble Boot Camp in Children With Classic Galactosemia. Am J Speech Lang Pathol. 2021 Nov 4;30(6):2616-2634. doi: 10.1044/2021_AJSLP-21-00098. Epub 2021 Oct 19.
PubMed 34665663Peter B, Potter N, Davis J, Donenfeld-Peled I, Finestack L, Stoel-Gammon C, Lien K, Bruce L, Vose C, Eng L, Yokoyama H, Olds D, VanDam M. Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia. F1000Res. 2019 Mar 11;8:271. doi: 10.12688/f1000research.18062.5. eCollection 2019.
PubMed 32566130
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Babble Boot Camp for Infants With Down Syndrome: Improving Speech and Language Outcomes Via a Proactive, Parent-led Intervention
- ClinicalTrials.gov ID
- NCT06450509
- Acronym / sponsor ID
- BBC-DS / STUDY00018407
- Conditions
- Down Syndrome
- Keywords
- Speech development, Language development, Linguistic environment, Parental stress, Babble complexity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- American Speech-Language-Hearing Foundation
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout adulthood. Because DS is diagnosed at or even before birth, these difficulties are predictable; yet despite this prognostic knowledge, systematic and sustained proactive interventions have not yet been developed: Most children with DS are not assessed and treated for speech and language delays until age 2 to 4 years. This presents an untapped opportunity space to conduct a clinical trial of a proactive intervention in earliest infancy with the goal of building resilience against the anticipated difficulties. The intervention trialed here is a modified version of Babble Boot Camp (BBC), a proactive speech and language intervention originally developed for young infants with classic galactosemia (CG) (NIH 5R01HD098253). CG is a metabolic disease that, similar to DS, is diagnosed at birth and poses risks for severe speech and language delays. BBC is implemented by a speech-language pathologist who, via telehealth, trains parents to incorporate skill-building activities and routines into their daily lives at home. For the present study, 20 children with DS age birth to 12 months will be recruited and randomized into two treatment arms. One group will receive weekly individualized parent sessions and close monitoring of the child's progress. The second group will receive the same content but at a lower intensity and dosage, via monthly parent group meetings. Both groups will receive their intervention for 10 months. Specific aims are to quantify benefits for babble, speech production, and receptive and expressive language and to investigate associations between conversational dynamics in child-adult interactions and the children's speech and language. Outcomes in speech and language skills will show relative feasibility and benefits for each of these treatment modalities and motivate a larger clinical trial, with the ultimate goal of changing the way infants with DS receive support in their speech and language development, from a deficit-based, remedial model to a proactive one.
Detailed description
Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout adulthood. Because DS is diagnosed at or even before birth, these difficulties are predictable; yet despite this prognostic knowledge, systematic and sustained proactive interventions have not yet been developed: Most children with DS are not assessed and treated for speech and language delays until age 2 to 4 years. This presents an untapped opportunity to conduct a clinical trial of a proactive intervention in earliest infancy with the goal of building resilience against the anticipated difficulties. The intervention trialed here is a modified version of Babble Boot Camp (BBC), a proactive speech and language intervention originally developed for young infants with classic galactosemia (CG) (NIH 5R01HD098253). CG is a metabolic disease that, similar to DS, is diagnosed at birth and poses risks for severe speech and language delays. BBC is implemented by a speech-language pathologist who, via telehealth, trains caregivers to incorporate skill-building activities and routines into their daily lives at home. For the present study, 20 children with DS age birth to 12 months will be recruited and randomized into one of two treatment arms. One group will receive weekly individualized caregiver sessions and close monitoring of the child's progress. The second group will receive the same content but at a lower intensity and dosage, via monthly caregiver group meetings. Both groups will receive their intervention for 10 months. At the beginning and end of the intervention, a set of data will be collected: At the beginning of the interventions, caregivers will be asked to complete an intake questionnaire with demographic information and information about the child's birth history, health history, and any services currently accessed. At the end of the intervention, caregivers will provide updates to this questionnaire and also a satisfaction survey. At pre and post, caregivers will provide three daylong audio recordings that will be analyzed for child utterance rates and conversational turns. For children age 6 months and up. these recordings will also be queried for segments with greatest numbers of child utterances, and these will be transcribed into International Phonetic Alphabet to obtain an objective measure of babble complexity, using the Mean Babbling Level, and, if sufficient numbers of meaningful utterances are found, an objective measure of word complexity using the Syllable Structure Level. At pre and post, questionnaires will be collected to appraise the children's general development and communication competence, using the Vineland Adaptive Behavior Scales 3. More detailed measures of early language skills, such as receptive and expressive vocabulary, will be obtained with the MacArthur-Bates Communicative Development Inventories -3. Age at emergence of first words will be recorded as a personal milestone for each child. Regarding parental well-being, the Parenting Stress Index 4 Short Form will be collected to obtain measures of stress originating in the parents themselves, in parent-child interactions, and in difficult child behaviors. This questionnaire also contains an estimate of whether or not parents are under-reporting their own personal stress. Specific aims are to quantify 1) benefits of each of the two interventions for babble and early speech sound production, 2) benefits of each of the two interventions for receptive and expressive language skills, and 3) associations between caregiver-child conversational dynamics during the intervention and child speech and language skill after the intervention. Outcomes in speech and language skills will show relative feasibility and benefits for each of these treatment modalities on children's speech and language development as well as parental well-being, and they will motivate a larger clinical trial, with the ultimate goal of changing the way infants with DS receive support in their speech and language development, from a deficit-based, remedial model to a proactive one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participating infants and their parents will be randomized into two different treatment modalities, either weekly individualized intervention sessions or monthly group sessions. Both groups will receive the intervention for a duration of 10 months. Note that in each family, the infant and both caregivers, where available, will be enrolled. In each treatment arm, there will be 10 infants and up to 20 caregivers, for a total of 20 infants and up to 40 caregivers.
| Arm | Type | Receives |
|---|---|---|
| Individual intervention | Experimental | Behavioral: Babble Boot CampIndividual 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 intervention | Active comparator | Behavioral: Babble Boot CampCaregivers 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 may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Full trisomy 21
- English is the main language spoken in the home
Key exclusion criteria (4 listed)
- Partial or mosaic trisomy 21
- Any additional condition that could confound the findings
- Awaiting heart surgery
- Born prematurely before 34 weeks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Babble Boot CampCaregivers are coached by a pediatric speech-language pathologist to implement activities and routines into their daily home lives with the intent to foster and boost their child's precursor and earliest speech and language skills. The intervention will be conducted entirely via telehealth. | Behavioural | Group intervention, Individual intervention |
Primary outcome
Linguistic environment
Time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Families will provide a set of three day-long audio recordings. Using the day-long audio recordings, the investigators will obtain adult word counts, child utterance counts, and conversational turn rates.
Child utterance complexity
Time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Child utterance complexity will be based on the six day-long audio recordings that will be provided by the families in sets of three each. For children age 6 months and up, the investigators will mine the day-long audio recordings for those 5-minute segments with the highest numbers of child utterances. These utterances will be transcribed into the International Phonetic Alphabet. The utterances will be scored for phonetic complexity based on the consonant and vowel content. For babbled utterances, the investigators will compute the Mean Babbling Level (scores range from 1 to 3), and for meaningful utterances, the investigators will compute the Syllable Structure Level (scores range from 1 to 4). For both of these measures, higher scores reflect greater utterance complexity. Child utterance complexity will be based on the six day-long audio recordings that will be provided by the families in sets of three each at the beginning (baseline) and end (10 months later) of the intervention.
MacArthur-Bates Communicative Inventories 3: Comprehensive Parent
Time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
In this checklist-based questionnaires, caregivers provide information about their child's language skills, for instance how many words the child understands and how many words the child produces. Point scores are converted into percentiles, where higher numbers reflect better outcomes.
Vineland Adaptive Behavior Scales 3: Comprehensive Parent/Caregiver Form
Time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Parents complete this questionnaire. Areas included in it are Communication, Daily Living Skills, Socialization, and Motor Skills. Point scores from the questionnaire are converted into standard scores and percentiles, where higher numbers reflect better outcomes.
Age at first words
Time frame: This milestone may occur at any point through the 10 months of intervention, or not at all.
For each child, the age at which she/he started to produce words is recorded.
2 secondary outcomes
Consonant and vowel inventory
Time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Parenting Stress Index 4 Short Form
Time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 37235746Potter NL, VanDam M, Bruce L, Davis J, Eng L, Finestack L, Heinlen V, Scherer N, Schrock C, Seltzer R, Stoel-Gammon C, Thompson L, Peter B. Virtual Post-Intervention Speech and Language Assessment of Toddler and Preschool Participants in Babble Boot Camp. J Speech Lang Hear Res. 2024 Sep 26;67(9S):3327-3339. doi: 10.1044/2023_JSLHR-22-00687. Epub 2023 May 26.
- Background: PubMed 37146603Peter B, Bruce L, Finestack L, Dinu V, Wilson M, Klein-Seetharaman J, Lewis CR, Braden BB, Tang YY, Scherer N, VanDam M, Potter N. Precision Medicine as a New Frontier in Speech-Language Pathology: How Applying Insights From Behavior Genomics Can Improve Outcomes in Communication Disorders. Am J Speech Lang Pathol. 2023 Jul 10;32(4):1397-1412. doi: 10.1044/2023_AJSLP-22-00205. Epub 2023 May 5.
- Background: PubMed 36251874Finestack LH, Potter N, VanDam M, Davis J, Bruce L, Scherer N, Eng L, Peter B. Feasibility of a Proactive Parent-Implemented Communication Intervention Delivered via Telepractice for Children With Classic Galactosemia. Am J Speech Lang Pathol. 2022 Nov 16;31(6):2527-2538. doi: 10.1044/2022_AJSLP-22-00107. Epub 2022 Oct 14.
- Background: PubMed 35677809Peter B, Davis J, Finestack L, Stoel-Gammon C, VanDam M, Bruce L, Kim Y, Eng L, Cotter S, Landis E, Beames S, Scherer N, Knerr I, Williams D, Schrock C, Potter N. Translating principles of precision medicine into speech-language pathology: Clinical trial of a proactive speech and language intervention for infants with classic galactosemia. HGG Adv. 2022 May 20;3(3):100119. doi: 10.1016/j.xhgg.2022.100119. eCollection 2022 Jul 14.
- Background: PubMed 34665663Peter B, Davis J, Cotter S, Belter A, Williams E, Stumpf M, Bruce L, Eng L, Kim Y, Finestack L, Stoel-Gammon C, Williams D, Scherer N, VanDam M, Potter N. Toward Preventing Speech and Language Disorders of Known Genetic Origin: First Post-Intervention Results of Babble Boot Camp in Children With Classic Galactosemia. Am J Speech Lang Pathol. 2021 Nov 4;30(6):2616-2634. doi: 10.1044/2021_AJSLP-21-00098. Epub 2021 Oct 19.
- Background: PubMed 32566130Peter B, Potter N, Davis J, Donenfeld-Peled I, Finestack L, Stoel-Gammon C, Lien K, Bruce L, Vose C, Eng L, Yokoyama H, Olds D, VanDam M. Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia. F1000Res. 2019 Mar 11;8:271. doi: 10.12688/f1000research.18062.5. eCollection 2019.
- Individual participant dataSharing planned: Yes. Only de-identified information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Peter principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Babble Boot Camp in people with Down Syndrome, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linguistic environment (time frame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450509, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.