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

NCT07738224 | Not Yet Recruiting

• 1 other identifier: 124255
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Premature Infants

Keywords

Early intervention; speech therapy; Caregiver-implemented

Outcome Measures

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)

  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 Outcomes (3)

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

  6-12 months corrected age (Intervention period)

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

  12-months corrected age (Post-intervention)

• Number of participants attending greater than 80 percent of intervention sessions

  child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)

Other Outcomes (1)

• Total distress score of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)

  child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)

Study Arms (2)

Babble Boot Camp

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

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.

Babble Boot Camp

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (2)

Murdoch Children's Research Institute

Melbourne, Victoria, Australia

Location

The Royal Women's Hospital

Melbourne, Victoria, Australia

Location

Related Publications (12)

• 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

  BACKGROUND

• 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.

  PMID: 36251874 BACKGROUND

• 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.

  PMID: 24950492 BACKGROUND

• 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.

  PMID: 40153250 BACKGROUND

• 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.

  PMID: 32566130 BACKGROUND

• Lovibond, S. H. (1995). Manual for the depression anxiety stress scales. Sydney psychology foundation.

  BACKGROUND

• 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.

  PMID: 27817913 BACKGROUND

• 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.

  PMID: 35263167 BACKGROUND

• 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.

  PMID: 35232455 BACKGROUND

• 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.

  PMID: 37235746 BACKGROUND

• 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.

  PMID: 34665663 BACKGROUND

• Brown, V. L., Bzoch, K. R., & League, R. (2021). Receptive-Expressive Emergent Language Test (4th ed.). PRO-ED.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Premature Birth; Communication Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Angela T Morgan

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela T Morgan

CONTACT

+61383416458; angela.morgan@mcri.edu.au

Victoria A Heinlen

CONTACT

victoria.heinlen@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As well as the outcome assessments, research assistants completing coding/rating and integrity/reliability assessments will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following analysis and article publication.
• 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

Locations

AU (2)