Proactive Speech and Language Intervention for Infants With Down Syndrome

Down Syndrome Clinical Trial

— BBC-DS  

Official title:

Babble Boot Camp for Infants With Down Syndrome: Improving Speech and Language Outcomes Via a Proactive, Parent-led Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450509
• Other study ID #: STUDY00018407
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: February 27, 2025

Study information

• Verified date: June 2024
• Source: Arizona State University
• Contact: Beate Peter, Ph.D.
• Phone: 206 713 5839
• Email: Beate.Peter[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 27, 2025
• Est. primary completion date: February 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

Inclusion Criteria:

• Full trisomy 21

• English is the main language spoken in the home

Exclusion Criteria:

• Partial or mosaic trisomy 21

• Any additional condition that could confound the findings

• Awaiting heart surgery

• Born prematurely before 34 weeks gestation

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Behavioral:
• Babble Boot Camp
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.

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	American Speech-Language-Hearing Foundation

Country where clinical trial is conducted

United States, 

References & Publications (6)

Finestack 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. — View Citation

Peter 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. — View Citation

Peter 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. — View Citation

Peter 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. — View Citation

Peter 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. — View Citation

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. 2023 May 26:1-13. doi: 10.1044/2023_JSLHR-22-00687. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linguistic environment	Using day-long audio recordings, the investigators will obtain adult word counts, child utterance counts, and conversational turn rates.	Families will provide a set of three day-long audio recordings at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later), each time within a three-week window.
Primary	Child utterance complexity	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.
Primary	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.	Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Primary	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.	Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Primary	Age at first words	For each child, the age at which she/he started to produce words is recorded.	This milestone may occur at any point through the 10 months of intervention, or not at all.
Secondary	Consonant and vowel inventory	From the phonetic transcriptions of the day-long audio recordings, an inventory of consonant and vowel sounds will be made.	Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Secondary	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.	Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)