Using the Babble Boot Camp© Speech Therapy Approach With Babies Born Prematurely (BBCPrem)
Babble Boot Camp© for Preterm Infants: A Trial of a Proactive Speech/Language Intervention
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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Angela T Morgan
- Telefonní číslo: +61383416458
- E-mail: angela.morgan@mcri.edu.au
Studijní záloha kontaktů
- Jméno: Victoria A Heinlen
- E-mail: victoria.heinlen@mcri.edu.au
Studijní místa
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Victoria
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Melbourne, Victoria, Austrálie
- The Royal Women's Hospital
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Dílčí vyšetřovatel:
- Beate Peter
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Dílčí vyšetřovatel:
- Victoria Heinlen
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Kontakt:
- Alicia Spittle
- E-mail: aspittle@unimelb.edu.au
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Kontakt:
- Victoria Heinlen
- E-mail: victoria.heinlen@mcri.edu.au
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Vrchní vyšetřovatel:
- Alicia Spittle
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Dílčí vyšetřovatel:
- Angela Morgan
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Melbourne, Victoria, Austrálie
- Murdoch Children's Research Institute
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Vrchní vyšetřovatel:
- Angela T Morgan
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Kontakt:
- Victoria A Heinlen
- E-mail: victoria.heinlen@mcri.edu.au
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Kontakt:
- Angela Morgan
- Telefonní číslo: +61383416458
- E-mail: angela.morgan@mcri.edu.au
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Dílčí vyšetřovatel:
- Alicia Spittle
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Dílčí vyšetřovatel:
- Beate Peter
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Dílčí vyšetřovatel:
- Victoria Heinlen
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Babble Boot Camp
Infants in the intervention group will be treated through collaboration between a speech pathologist and one (or both, if available) parent.
The principles and goals of the intervention are related to the deficits commonly seen in infants born preterm, with individualised strategies to be used in the home to support prelinguistic speech and language skills.
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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 daily routines and activities. The parent will record 2-3 short videos of their child to be submitted to the therapist weekly prior to the telehealth session. |
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Žádný zásah: Usual Care
Infants enrolled in both groups will receive usual care in the community as it is unethical to withhold care.
Typical services include routine medical care, social work support, physiotherapy, occupational, or speech therapy assessments, and referral to local early intervention programs as deemed necessary by the primary medical team.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)
Časové okno: 12-months corrected age (Post-intervention)
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The REEL-4 Language ability composite score combines the expressive language and receptive language subtests of the standardized assessment into one score to measure the overall language ability of a participant.
The REEL-4 is a standardized assessment using standard scores ranging from 40 to 160, with an average score of 100.
Scores are interpreted using standard deviation units of 15 points, meaning scores between 85 and 115 fall within the typical range.
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12-months corrected age (Post-intervention)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance]
Časové okno: 6-12 months corrected age (Intervention period)
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Parents in the BBC treatment group will submit videos of their child during the duration of the trial to assess the use of BBC in daily routines successfully.
Compliance with use of BBC components is defined as a video submitted containing the use of at least one BBC communication component.
Parent compliance in the BBC treatment group will be summarised as the mean percentage of videos successfully including communication components.
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6-12 months corrected age (Intervention period)
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Number of participants attending greater than 80 percent of intervention sessions
Časové okno: child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)
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The number and percentage of participants who attended greater than 80 percent of sessions will be given.
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child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)
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Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability (TFA)
Časové okno: 12-months corrected age (Post-intervention)
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Caregiver's views of the trial using the Theoretical Framework of Acceptability will be measured using an adapted questionnaire from Sekhon et.al., modified for the BBC Prem intervention to assess the design, evaluation, and implementation of the intervention (Sekhon et.al., 2022).
Likert scales will be used to measure several items - scores will range from 1-5, where higher scores could indicate a better or worse outcome depending on the item.
The items will be summarised by reporting the median per item.
Answers to open ended questions answers will be collated and themes identified will be reported.
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12-months corrected age (Post-intervention)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total distress scores of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)
Časové okno: child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)
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The Depression, Anxiety, and Stress Scales (DASS-21) total distress score will be assessed.
Each item on rating scale is reported 0-3 where higher scores indicate a worse outcome.
The mean difference in the total scores of the items will be reported.
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child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Angela T Morgan, Murdoch Childrens Research Institute
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- Brown, V. L., Bzoch, K. R., & League, R. (2021). Receptive-Expressive Emergent Language Test (4th ed.). PRO-ED.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Neurologické projevy
- Nemoci nervového systému
- Duševní poruchy
- Ženské urogenitální onemocnění a těhotenské komplikace
- Porodnický porod, předčasný
- Porodnické porodní komplikace
- Těhotenské komplikace
- Neurobehaviorální projevy
- Neurologické vývojové poruchy
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Předčasný porod
- Poruchy komunikace
Další identifikační čísla studie
- 124255
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The de-identified data set collected for the analysis of this trial will be made available analysis and publication of the primary outcome. The following will be made available long-term for use by future researchers from a recognised research institution:
Individual participant data that underlie the results reported after anonymisation/deidentification (text, tables, figures and appendices), Trial protocol, Participant Information and Consent Form (PICF), Statistical Analysis Plan (SAP), statistical code. Note that the data sharing of de-identified speech and language data is an Optional Consent for participants.
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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