Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth

Официальное название

Milieu Teaching-AV: A Study to Assess an Adaptation of Milieu Teaching for Infant Siblings of Autistic Children That Encourages Looking to the Mouth

Обзор

This project will look at Milieu Teaching (i.e., a language intervention) that encourages looking to audiovisual speech cues (Milieu Teaching-AV) for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD), compared to Milieu Teaching alone (Milieu Teaching-NoAV). This study will specifically look at whether Milieu Teaching-AV (compared to Milieu Teaching-NoAV) results in (a) increased looking towards caregivers' faces, (b) increased communicative behaviors and language skill, and (c) increased engagement with the caregiver during play. We will also look at caregiver factors, such as their use of strategies and their attitudes toward the intervention they received.

Подробное описание

Language outcomes are highly heterogenous in autism and can impact long-term psychosocial, educational, and vocational outcomes for children on the autism spectrum. Thus, there is a pressing need to identify novel approaches to language intervention, ideally those that can be implemented in early stages of development, when brain and behavior are most plastic. Many have begun to consider "pre-emptive" interventions for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD) themselves.

I hypothesize that a targeted pre-emptive intervention that encourages Sibs-autism to look to the mouth of a speaker (i.e., by moving a referent, or the item about which an adult is talking, near the mouth) during an evidence-based intervention for language may yield more optimal language outcomes than traditional therapy alone. This strategy has already been shown to boost word learning in autistic preschoolers, at least for proximal targets (i.e., for words that were specifically taught using the strategy in a short-term training context).

This study represents a preliminary systematic test of this strategy in Sibs-autism. I will evaluate the effects of an intervention that encourages looking to audiovisual speech by moving the referent of interventionist talk near the mouth (Milieu Teaching-AV) compared to Milieu Teaching-NoAV in a total of 60 Baby Sibs within the context of a pilot randomized controlled trial (RCT). This pilot RCT will allow me to estimate effect sizes for (a) direct effects on word learning, both for trained words and broader language, (b) moderated effects (i.e., determining for whom the intervention yields optimal outcomes), and (c) mediated effects (i.e., determining the mechanisms by which the intervention works).

Вмешательства

• Поведенческое Milieu Teaching-AV
  Milieu Teaching is a previously developed and well established Naturalistic Developmental Behavioral Intervention. Key principles of Milieu Teaching include: (a) individualized treatment goals based on the child's entry-level communication abilities, (b) use of environmental arrangement, reciprocal social interactions and/or play routines with balanced turns to maximize engagement and opportunities for child attention or communication leads, (c) child-initiated teaching episodes, (d) adult model
• Поведенческое Milieu Teaching-NoAV
  Milieu Teaching is a previously developed and well established Naturalistic Developmental Behavioral Intervention. Key principles of Milieu Teaching include: (a) individualized treatment goals based on the child's entry-level communication abilities, (b) use of environmental arrangement, reciprocal social interactions and/or play routines with balanced turns to maximize engagement and opportunities for child attention or communication leads, (c) child-initiated teaching episodes, (d) adult model

Первичные конечные точки

• Looking to the mouth of their caregiver [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]
• Looking to the mouth of a speaker [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]

Вторичные конечные точки (6)

• Prelinguistic vocal complexity [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]
• Caregiver-child engagement [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]
• Expressive and receptive communication [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]
• Expressive and receptive language [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]
• Expressive and receptive vocabulary [Срок оценки: 6-month follow-up]
• Caregiver strategy use [Срок оценки: Baseline, following 3 months of intervention (i.e., post-test), and 6-month follow-up]

Критерии участия

Критерии включения

• chronological age of 6-12 months at study entry (±30 days);
• an older sibling with an autism diagnosis, confirmed by a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule (ADOS-2); and
• monolingual English-speaking household.

Критерии исключения

• adverse neurological history;
• known genetic condition;
• pre-term birth (gestation < 37 weeks); and
• caregiver report of a diagnosed vision impairment or hearing loss

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Boys Town National Research Hospital — Omaha

Идентификаторы

NCT: NCT07494513 · 26-002 · 5K99DC021501-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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