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

September 1, 2026 updated by: 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • The Royal Women's Hospital
        • Sub-Investigator:
          • Beate Peter
        • Sub-Investigator:
          • Victoria Heinlen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alicia Spittle
        • Sub-Investigator:
          • Angela Morgan
      • Melbourne, Victoria, Australia
        • Murdoch Children's Research Institute
        • Principal Investigator:
          • Angela T Morgan
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alicia Spittle
        • Sub-Investigator:
          • Beate Peter
        • Sub-Investigator:
          • Victoria Heinlen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance]
Time Frame: 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
Time Frame: 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)
Time Frame: 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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total distress scores of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Investigators

  • Principal Investigator: Angela T Morgan, Murdoch Childrens Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

July 26, 2026

First Submitted That Met QC Criteria

July 26, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Time Frame

Following analysis and article publication.

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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