Proactive Speech and Language Intervention for Infants With Down Syndrome

NCT06450509 | Completed

• 1 other identifier: STUDY00018407
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Speech development; Language development; Linguistic environment; Parental stress; Babble complexity

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  This milestone may occur at any point through the 10 months of intervention, or not at all.

Secondary Outcomes (2)

• Consonant and vowel inventory

  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

  Collected at the beginning of the intervention (baseline) and again at the end of the intervention (10 months later)

Study Arms (2)

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.

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.

Behavioral: Babble Boot Camp

Interventions

Babble Boot Camp BEHAVIORAL

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.

Group intervention; Individual intervention

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full trisomy 21
• English is the main language spoken in the home

You may not qualify if:

• Partial or mosaic trisomy 21
• Any additional condition that could confound the findings
• Awaiting heart surgery
• Born prematurely before 34 weeks gestation

Sponsors & Collaborators

• Arizona State University: lead
• American Speech-Language-Hearing Foundation: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

Related Publications (6)

• 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.

  PMID: 37235746 BACKGROUND

• 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.

  PMID: 37146603 BACKGROUND

• 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.

  PMID: 36251874 BACKGROUND

• 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.

  PMID: 35677809 BACKGROUND

• 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.

  PMID: 34665663 BACKGROUND

• 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.

  PMID: 32566130 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Beate Peter

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals who analyze the audio recordings and score the questionnaires will not know the group assignments of the families.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: June 10, 2024
• Study Start: February 28, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be shared starting in February 2025 for a period of 5 years.
• Access Criteria: Qualified researchers must contact the PI to request access to the data.

Locations

US (1)