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

1. September 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

86

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Australien
    • Victoria
      • Melbourne, Victoria, Australien
        • The Royal Women's Hospital
        • Unterermittler:
          • Beate Peter
        • Unterermittler:
          • Victoria Heinlen
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Alicia Spittle
        • Unterermittler:
          • Angela Morgan
      • Melbourne, Victoria, Australien
        • Murdoch Children's Research Institute
        • Hauptermittler:
          • Angela T Morgan
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Alicia Spittle
        • Unterermittler:
          • Beate Peter
        • Unterermittler:
          • Victoria Heinlen

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance]
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total distress scores of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Murdoch Childrens Research Institute

Ermittler

  • Hauptermittler: Angela T Morgan, Murdoch Childrens Research Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. August 2028

Studienabschluss (Geschätzt)

1. August 2028

Studienanmeldedaten

Zuerst eingereicht

26. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juli 2026

Zuerst gepostet (Tatsächlich)

31. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 124255

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

Following analysis and article publication.

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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