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

1. september 2026 oppdatert av: Murdoch Childrens Research Institute

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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

86

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • The Royal Women's Hospital
        • Underetterforsker:
          • Beate Peter
        • Underetterforsker:
          • Victoria Heinlen
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alicia Spittle
        • Underetterforsker:
          • Angela Morgan
      • Melbourne, Victoria, Australia
        • Murdoch Children's Research Institute
        • Hovedetterforsker:
          • Angela T Morgan
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Alicia Spittle
        • Underetterforsker:
          • Beate Peter
        • Underetterforsker:
          • Victoria Heinlen

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)
Tidsramme: 12-months corrected age (Post-intervention)
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.
12-months corrected age (Post-intervention)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance]
Tidsramme: 6-12 months corrected age (Intervention period)
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.
6-12 months corrected age (Intervention period)
Number of participants attending greater than 80 percent of intervention sessions
Tidsramme: child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)
The number and percentage of participants who attended greater than 80 percent of sessions will be given.
child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)
Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability (TFA)
Tidsramme: 12-months corrected age (Post-intervention)
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.
12-months corrected age (Post-intervention)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total distress scores of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)
Tidsramme: child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)
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.
child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Murdoch Childrens Research Institute

Etterforskere

  • Hovedetterforsker: Angela T Morgan, Murdoch Childrens Research Institute

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. august 2028

Datoer for studieregistrering

Først innsendt

26. juli 2026

Først innsendt som oppfylte QC-kriteriene

26. juli 2026

Først lagt ut (Faktiske)

31. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 124255

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Following analysis and article publication.

Tilgangskriterier for IPD-deling

Future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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