Effect of Infant Sign Training on Speech-language Development

Официальное название

The Effect of Using Symbolic Gestures on the Speech and Language Development in Prelinguistic Children Born With Cleft Palate

Обзор

Children born with a cleft lip and palate (CLP) are known to be at risk for speech-language disorders that impact academic and social emotional growth. Even at very young ages (\<3 years), speech-language disorders are already observed. It is hypothesized that speech-language intervention delivered before the age of 3 years old could decrease the impact of CLP on speech-language development. This would result in a decreased need for speech-language therapy on the long-term and a reduced burden of care on children, families and health services. However, no evidence is yet available to support any specific model of early speech-language intervention in this population. Consequently, no standardized clinical practice guidelines are available yet. Symbolic gesture training in combination with verbal input expands the natural communication of young children including multimodal speech-language input (i.e., verbal and manual input) via caregivers who act as co-therapists. To contribute to the evidence-based practice in the field of cleft speech therapy, this research project aims to determine the effectiveness and feasibility of symbolic gesture training in one-year old children with CLP by comparing different intervention approaches based on perceptual, psychosocial and qualitative outcome measures.

Подробное описание

Children with CP±L are known to be at risk for speech-language delays that impact educational and social-emotional growth. Early intervention in this population mostly focuses on improving verbal input via caregivers or professionals without including a multimodal language input. As stated above, no evidence is yet available for the effectiveness and feasibility of early intervention based on symbolic gesture training in combination with verbal input to improve speech-language skills in young children with CP±L. To contribute to the evidence-based practice in the field of early cleft palate speech intervention, this research project will focus on the effectiveness of symbolic gesture training in one-year old children with CP±L by comparing different intervention approaches based on quantitative and qualitative outcome measures. This project meets the need to evaluate the impact of early intervention on speech-language outcomes in children with CP±L as proposed by several researchers based on reviews regarding this topic.

The primary objective is to explore if children with CP±L who are enrolled in symbolic gesture training to support verbal in- and output at the age of 12 months have increased receptive and expressive language skills compared to children with CP±L who are enrolled in verbal training or not involved in any intervention at all.

The secondary objectives are:

2.1 To explore if children with CP±L who are enrolled in symbolic gesture training at the age of 12 months have improved speech skills, compared to children with CP±L who are enrolled in verbal training or not involved in any intervention at all; 2.2 To explore if children with CP±L who are enrolled in symbolic gesture training at the age of 12 months demonstrate more gesture use, compared to children with CP±L who are enrolled in verbal training or not involved in any intervention at all; 2.3 To explore if caregivers of children with CP±L who are enrolled in symbolic gesture training when their child is 12 months of age provide more frequent and more complex linguistic input to their child's utterances compared to caregivers of children with CP±L who are enrolled in verbal training or not involved in any intervention at all.

Вмешательства

• Поведенческое Infant sign training
  Training session 1: Information is given about what infant signs are, how they originated, how speech and (gestural) language develop in young children with CP ± L, the possible advantages of using infant signs and tips for success. Twelve signs are chosen to start with: six narrative signs (mostly object concepts) and six steering signs (mostly non-object concepts). Training session 2: Experiences with using infant signs at home are shared, repetition of the 12 infant signs and tips for success
• Поведенческое Verbal training
  Training session 1: Information is given about how speech and language develop in young children with CP ± L and how caregivers can support their child during this development Tips for success and suggestions on how to use these supportive verbal techniques at home are discussed. Training session 2: Experiences with using supportive verbal techniques at home are shared and supportive verbal techniques repeated. Information is provided about how children learn new words and tips for success are e

Первичные конечные точки

• Receptive language level based on language test [Срок оценки: 12 months]
• Expressive language level based on language test [Срок оценки: 12 months]
• Total language level based on caregiver report [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Communicative acts produced by the child [Срок оценки: 12 months]
• Communicative acts produced by the caregiver [Срок оценки: 12 months]
• Articulatory precision of the child [Срок оценки: 12 moths]

Критерии участия

Критерии включения

• Born with cleft palate (with or without cleft lip)
• Having Dutch as mother tongue

Критерии исключения

• syndromic cleft
• more than mild hearing loss (i.e. > 40dB hearing threshold bilaterally)
• neurosensory hearing loss
• cognitive delay
• motor delay

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Ghent University Hospital — Ghent

Публикации

• De Ryck M, Van Lierde K, Alighieri C, Hens G, Bettens K. A protocol for a randomized-controlled trial to investigate the effect of infant sign training on the speech-language development in young children born with cleft palate. Int J Lang Commun Disord. 2023 Nov-Dec;58(6):2212-2221. doi: 10.1111/1460-6984.12920. Epub 2023 Jun 28. PMID 37376898
• Lancaster HS, Lien KM, Chow JC, Frey JR, Scherer NJ, Kaiser AP. Early Speech and Language Development in Children With Nonsyndromic Cleft Lip and/or Palate: A Meta-Analysis. J Speech Lang Hear Res. 2019 Dec 13;63(1):14-31. doi: 10.1044/2019_JSLHR-19-00162. Print 2020 Jan 22. PMID 31841365
• Scherer NJ, Boyce S, Martin G. Pre-linguistic children with cleft palate: growth of gesture, vocalization, and word use. Int J Speech Lang Pathol. 2013 Dec;15(6):586-92. doi: 10.3109/17549507.2013.794475. Epub 2013 Sep 27. PMID 24073662
• Lane H, Harding S, Wren Y. A systematic review of early speech interventions for children with cleft palate. Int J Lang Commun Disord. 2022 Jan;57(1):226-245. doi: 10.1111/1460-6984.12683. Epub 2021 Nov 12. PMID 34767284
• Bessell A, Sell D, Whiting P, Roulstone S, Albery L, Persson M, Verhoeven A, Burke M, Ness AR. Speech and language therapy interventions for children with cleft palate: a systematic review. Cleft Palate Craniofac J. 2013 Jan;50(1):e1-e17. doi: 10.1597/11-202. Epub 2012 Mar 20. PMID 22433039
• Chapman KL, Hardin-Jones M, Halter KA. The relationship between early speech and later speech and language performance for children with cleft lip and palate. Clin Linguist Phon. 2003 Apr-May;17(3):173-97. doi: 10.1080/0269920021000047864. PMID 12858838
• Frey JR, Kaiser AP, Scherer NJ. The Influences of Child Intelligibility and Rate on Caregiver Responses to Toddlers With and Without Cleft Palate. Cleft Palate Craniofac J. 2018 Feb;55(2):276-286. doi: 10.1177/1055665617727000. Epub 2017 Dec 14. PMID 29351026

Идентификаторы

NCT: NCT06143254 · ONZ-2022-0581

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗