Using the Babble Boot Camp© Speech Therapy Approach With Babies Born Prematurely

Официальное название

Babble Boot Camp© for Preterm Infants: A Trial of a Proactive Speech/Language Intervention

Обзор

Babble Boot Camp focuses on early speech and language development, environmental enrichment and supporting parent-infant interaction with the aim of improving communication outcomes and parental well-being in at risk children. The goal of this clinical trial is to learn if this parent-coaching speech therapy intervention delivered via telehealth helps to support babies born very preterm with their earliest stages of communication. The main questions it aims to answer are: Does Babble Boot Camp increase language outcomes in infants born very preterm? Is Babble Boot Camp able to be successfully completed by caregivers, and do caregivers believe Babble Boot Camp is possible to implement at home? What is the family impact of Babble Boot Camp? Participants will: Be randomly assigned into either a "treatment group" or a "usual care group." If allocated into the treatment group using Babble Boot Camp, participants will attend weekly 15-minute therapy sessions with a speech pathologist for 6 months. Both groups ("treatment group" or a "usual care group") will complete questionaries at enrollment and when the child participant is 6, and 12 months old (corrected age).

Подробное описание

Babble Boot Camp (BBC) is an evidence-based proactive, systematic, and longitudinal speech/language intervention for babies ages 2-24 months of age to infants and toddlers at risk of communication impairment (Peter et al., 2020). The approach was designed to prevent or minimize speech and language disorders in infants at predictable risk by fostering precursor and early communication skills via parent training (Potter et.al, 2023). BBC is parent or caregiver implemented to reinforce functional, practical, and developmentally appropriate prelinguistic and early speech skills (Peter et al., 2020). Specifically targeted treatment routines include a "word bath" with infant directed prosody, facial expressions, responding to infant vocalizations, modeling and reinforcing babbling, labeling objects, modeling word productions, and recasting/expanding upon the child's utterances (Peter et. Al., 2021; Peter et.al.,2025). BBC has been trialed with great success in Classic Galactosemia, and with feasibility for children with Down Syndrome (Peter et al., 2021; Peter et al., 2025). During the weekly 15-20-minute speech therapy sessions, the speech pathologist follows a Teach-Model-Coach-Review-Questions format based on the teach-model-coach-review instructional approach (Robert et.al., 2014). Parents are then to implement learned strategies and routines daily including the addition of watching videos of babies babbling and joint picture book reading. All routines are targeted on what the child can access with support to account for the Zone of Proximal Development (Vygotsky, 1979). BBC researchers were able to show the intervention was feasible for families in the original trial group containing children with Classic Galacosemia (Finestack et. al, 2022). This suggests that BBC could potentially be possible to use with other populations.

In this trial, the intervention program commences at 6 months corrected age and continues via telehealth up to 12 months' corrected age. The intervention is delivered by a speech pathologist. This randomised controlled trial (RCT) of BBC compared with usual care, will evaluate the efficacy of BBC intervention which is delivered earlier than traditional health service models provide, at a more developmentally appropriate time, and unrestricted by geographical location, for infants born preterm and their families.

The primary goal of this trial is to examine the efficacy of BBC with children born preterm. Additional secondary outcomes include parent compliance, parent views of the trial, and describing the participants with highest attendance. A further exploratory outcome to be measured will include family impact of treatment on depression/anxiety/stress.

Вмешательства

• Поведенческое Babble Boot Camp
  The intervention will be delivered by the following method: Weekly 15-minute telehealth sessions with topics around understanding and responding to infant behaviour, promoting development through enhanced parent child interaction and demonstrating intervention activities. Toys will be used to facilitate language development with parents coached on appropriate interactions. During these sessions, the therapist will coach the parent to deliver intervention activities with their infant during dail

Первичные конечные точки

• Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4) [Срок оценки: 12-months corrected age (Post-intervention)]

Вторичные конечные точки (3)

• Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance] [Срок оценки: 6-12 months corrected age (Intervention period)]
• Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability measured via a questionnaire modified for the BBC intervention [Срок оценки: 12-months corrected age (Post-intervention)]
• Number of participants attending greater than 80 percent of intervention sessions [Срок оценки: child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)]

Критерии участия

Критерии включения

• Infants born <32 weeks' gestational age (GA)
• Infants medically stable and not ventilator dependent at recruitment
• Primary language spoken at home is English
• Participants able to attend 6 months of telehealth early intervention
• Infants less than 5.5 months corrected age

Критерии исключения

• Diagnosis of a chromosomal or genetic anomaly known to affect development,
• Significant hearing and vision loss
• Clefting of the lip or palate
• Hypoxic ischemic encephalopathy
• Intraventricular haemorrhage grade 3 or 4
• Participants participating in any other trials including BBC

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Австралия · 2 центра

• Murdoch Children's Research Institute — Melbourne
• The Royal Women's Hospital — Melbourne

Публикации

• Vygotsky, L.S. (1979). The development of higher forms of attention in childhood. Soviet Psychology, 18(1), 67-115. https://doi.org/10.2753/RPO1061-0405180167
• 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
• Roberts MY, Kaiser AP, Wolfe CE, Bryant JD, Spidalieri AM. Effects of the teach-model-coach-review instructional approach on caregiver use of language support strategies and children's expressive language skills. J Speech Lang Hear Res. 2014 Oct;57(5):1851-69. doi: 10.1044/2014_JSLHR-L-13-0113. PMID 24950492
• Peter B, Finestack L, Loveall S, Thompson L, Bruce L, Scherer N, Stoel-Gammon C, Davis J, Potter N, VanDam M, Eng L, Buckley S. Babble Boot Camp for Infants With Down Syndrome: Piloting a Proactive, Caregiver-Led Intervention Designed to Boost Earliest Speech and Language Skills. Am J Speech Lang Pathol. 2025 May 6;34(3):1041-1057. doi: 10.1044/2024_AJSLP-24-00271. Epub 2025 Mar 28. PMID 40153250
• 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
• Lovibond, S. H. (1995). Manual for the depression anxiety stress scales. Sydney psychology foundation.
• Spittle A, Treyvaud K. The role of early developmental intervention to influence neurobehavioral outcomes of children born preterm. Semin Perinatol. 2016 Dec;40(8):542-548. doi: 10.1053/j.semperi.2016.09.006. Epub 2016 Nov 3. PMID 27817913
• van Noort-van der Spek IL, Dudink J, Reiss IK, Franken MJP. Early Speech Sound Production and Its Trajectories in Very Preterm Children From 2 to 4 Years of Age. J Speech Lang Hear Res. 2022 Apr 4;65(4):1294-1310. doi: 10.1044/2021_JSLHR-21-00388. Epub 2022 Mar 9. PMID 35263167

Идентификаторы

NCT: NCT07738224 · 124255

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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