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NCT07738224

Overview

NCT ID: NCT07738224
Lead Sponsor: Murdoch Childrens Research InstituteOTHER
Official Title: Babble Boot Camp© for Preterm Infants: A Trial of a Proactive Speech/Language Intervention
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).

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Aug 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 86Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Angela T MorganContact
angela.morgan@mcri.edu.au+61383416458

Similar Studies

Participant Group/Arms

Babble Boot CampExperimental

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 CareNo 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.