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临床试验/NCT07738224
NCT07738224尚未招募不适用

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

Murdoch Childrens Research Institute2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
86
试验地点
2
主要终点
Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

As well as the outcome assessments, research assistants completing coding/rating and integrity/reliability assessments will be blinded.

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

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.

干预措施: Babble Boot Camp (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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))
  • Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability (TFA)(12-months corrected age (Post-intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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