Using the Babble Boot Camp© Speech Therapy Approach With Babies Born Prematurely (BBCPrem)
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).
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Angela T Morgan
- 電話番号：+61383416458
- メール：angela.morgan@mcri.edu.au
研究連絡先のバックアップ
- 名前：Victoria A Heinlen
- メール：victoria.heinlen@mcri.edu.au
研究場所
-
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Victoria
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Melbourne、Victoria、オーストラリア
- The Royal Women's Hospital
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副調査官：
- Beate Peter
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副調査官：
- Victoria Heinlen
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コンタクト：
- Alicia Spittle
- メール：aspittle@unimelb.edu.au
-
コンタクト：
- Victoria Heinlen
- メール：victoria.heinlen@mcri.edu.au
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主任研究者：
- Alicia Spittle
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副調査官：
- Angela Morgan
-
Melbourne、Victoria、オーストラリア
- Murdoch Children's Research Institute
-
主任研究者：
- Angela T Morgan
-
コンタクト：
- Victoria A Heinlen
- メール：victoria.heinlen@mcri.edu.au
-
コンタクト：
- Angela Morgan
- 電話番号：+61383416458
- メール：angela.morgan@mcri.edu.au
-
副調査官：
- Alicia Spittle
-
副調査官：
- Beate Peter
-
副調査官：
- Victoria Heinlen
-
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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. |
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean difference between arms in the Language ability composite score as assessed by the Receptive-Expressive Emergent Language Test-Fourth Edition (REEL-4)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean percentage of parent-submitted videos that include at least one BBC program communication component (BBC Intervention group) [measuring parent compliance]
時間枠：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.
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6-12 months corrected age (Intervention period)
|
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Number of participants attending greater than 80 percent of intervention sessions
時間枠：child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)
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The number and percentage of participants who attended greater than 80 percent of sessions will be given.
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child participant age 6-12 months CA (Intervention period), child participant age 12 months CA (post-intervention)
|
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Acceptability of the trial to caregivers using the Theoretical Framework of Acceptability (TFA)
時間枠：12-months corrected age (Post-intervention)
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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.
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12-months corrected age (Post-intervention)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total distress scores of adult participants assessed using the Depression, Anxiety, and Stress Scales (DASS-21)
時間枠：child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)
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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.
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child participant 5-6 months CA (enrollment/baseline), child participant 12 months CA (post-intervention)
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協力者と研究者
捜査官
- 主任研究者：Angela T Morgan、Murdoch Childrens Research Institute
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- Lovibond, S. H. (1995). Manual for the depression anxiety stress scales. Sydney psychology foundation.
- 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.
- 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.
- Brown, V. L., Bzoch, K. R., & League, R. (2021). Receptive-Expressive Emergent Language Test (4th ed.). PRO-ED.
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 124255
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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