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NCT Number: NCT07738224

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

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).

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Murdoch Children's Research Institute, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Babble Boot Camp

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability measured via a questionnaire modified for the BBC intervention

    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 intervention to assess the design, evaluation, and implementation of the intervention (Sekhon et.al., 2022). Likert scale 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.

  3. 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.

Other outcomes

  1. Total distress score 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. The mean difference in the total score will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela T Morgan

CONTACT

[email protected]

+61383416458

Victoria A Heinlen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Registry information

Official study title

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

Acronym: BBCPrem

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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