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Recruiting NCT05743439

Early Augmentative and Alternative Communication (AAC) Intervention Delivered Via Hybrid Telehealth

Conditions: Intellectual Disability, Speech and Language Disorder

Sex: All
Ages: 24 Months – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Oregon Health and Science University

Location: United States

Summary

The goal of this mixed methods study aims to develop and pilot test an augmentative and alternative communication (AAC) intervention for toddlers with intellectual and developmental disabilities (IDD) and their families. The main question it aims to answer is: Will this AAC intervention improve caregivers' use of naturalistic AAC intervention strategies, leading to increases in children's communication? The investigators will employ qualitative methods to conduct interviews to determine caregiver and speech-language pathologist preferences regarding an AAC intervention. Findings from these interviews will inform the adaptation of the AAC intervention procedures, service delivery approach, and strategies to increase caregiver's treatment adherence. Next, the researchers will conduct six multiple baseline designs across behaviors (AAC strategies) to develop the AAC intervention and demonstrate preliminary efficacy when delivered to families in-person. Caregiver-child dyads will receive 24 in-person intervention sessions during which the therapist will provide AAC instruction and coaching on using AAC strategies to caregivers. Last, the investigators will pilot test the AAC intervention using a hybrid telehealth model with nine caregiver-child dyads. Caregiver-child dyads will receive 24 intervention sessions, eight sessions provided to families in-person, and 16 sessions provided to families via telehealth.Our long-term goal is to develop a socially valid and effective intervention to improve language outcomes for toddlers with IDD. The researchers propose developing and pilot testing a hybrid telehealth AAC intervention for toddlers with IDD and their families. Researchers employ an implementation science approach, using systematic qualitative methods to identify caregivers' preferences and single-case experimental design methods to assess the feasibility of the AAC intervention. The central hypothesis is that the intervention will improve caregivers' use of naturalistic AAC intervention strategies, leading to increases in children's communication.

Eligibility Criteria

Speech-Language Pathologists:age > 18 yearsfull or part-time employment providing language intervention to children 24 - 36 months with IDDhas at least 1 child on their caseload who uses AAChas 2 or more years of experience providing AAC to children with IDDable to speak, understand, and read English.Caregivers:age > 18 yearsparent, primary caregiver, or legal guardian of a child age 24 - 36 months with IDDhas at least 6 months of experience receiving early intervention, andable to speak, understand, and read English.Children:age 24 - 36 monthsdiagnosis of IDD confirmed by caregiver or medical recordsevere developmental delay, defined as a score of > 2 standard deviations below the mean on the Mullen Scales of Early Learning (MSEL) Early Learning Compositesevere expressive language impairment, defined as a score of < 12 months on the Expressive Language Subscale of the MSEL and expressive vocabulary and < 10 words (signs, or symbols) per caregiver report on the MacArthur-Bates Communicative Development Inventories Words and Gestures (MCDI-WG)receptive vocabulary of at least 50 words, per caregiver report on MCDI-WGuse of intentional communication behaviors, defined as a score of > 7 on the Communication Complexity Scalesufficient motor skills to sit upright with support, interact with toys provided during the assessment, and access the AAC systemhearing within normal limits, defined as 0 to 25 dbHL in at least one earvision within normal limits, defined as 20/80 visual acuity or better in at least one eye, andexposure to English in the home or community.Children with uncontrolled seizure disorders will be excluded.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05743439). StuddyBuddy aggregates publicly available trial information.