Clinical trial NCT06450509: Proactive Speech and Language Intervention for Infants With Down Syndrome
Official title: Babble Boot Camp for Infants With Down Syndrome: Improving Speech and Language Outcomes Via a Proactive, Parent-led Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Speech development
Language development
Linguistic environment
Parental stress
Babble complexity
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: American Speech-Language-Hearing Foundation
First posted: 2024-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Linguistic environment
timeFrame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
measure: Child utterance complexity
timeFrame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
measure: MacArthur-Bates Communicative Inventories 3: Comprehensive Parent
timeFrame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
measure: Vineland Adaptive Behavior Scales 3: Comprehensive Parent/Caregiver Form
timeFrame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
measure: Age at first words
timeFrame: This milestone may occur at any point through the 10 months of intervention, or not at all.
Secondary outcomes:
measure: Consonant and vowel inventory
timeFrame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
measure: Parenting Stress Index 4 Short Form
timeFrame: Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Beate Peter
role: PRINCIPAL_INVESTIGATOR
References:
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. 2024 Sep 26;67(9S):3327-3339. doi: 10.1044/2023_JSLHR-22-00687. Epub 2023 May 26.
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.
citation: 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.
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.
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.
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.