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

NCT05743439 | Recruiting

• 1 other identifier: STUDY00021611
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intellectual Disability; Speech and Language Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Use of AAC Intervention Strategies

  Observational assessment of caregivers' use of AAC strategies during a 15-min caregiver-child interaction. The primary dependent variable is the caregiver's use of AAC strategies. The metric is the accuracy of AAC strategy use calculated by (correct strategy steps/ total strategy steps X100).

  Assessed 1-2 times per week through study completion, 3-4 months.

Secondary Outcomes (1)

• Change in Number of Child Communication Acts

  Assessed 1-2 times per week through study completion, 3-4 months.

Other Outcomes (6)

• Change in Acceptability of Intervention Measure (AIM)

  Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months

• Change in Intervention Appropriateness Measure (IAM)

  Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months

• Change in Feasibility of Intervention Measure (FIM)

  Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months

Study Arms (1)

Early Augmentative and Alternative Communication (AAC) Intervention

EXPERIMENTAL

After a period of stable baseline performance (3 to 5 sessions) on parent and child outcomes, the interventionist will apply the early AAC intervention.

Behavioral: Early Augmentative and Alternative Communication (AAC) Intervention

Interventions

Early Augmentative and Alternative Communication (AAC) Intervention BEHAVIORAL

Caregivers will receive 24, 50 min intervention sessions twice a week for three months. During each intervention session, the therapist provides instruction and coaching on using AAC and a set of evidence-based language support strategies. Strategies are taught sequentially in three phases: (1) Responding to all Communication, (2) Teaching Words, and (3) Creating Communication Opportunities. Caregivers practice using the AAC intervention strategies during three, five-minute routines with their children. Therapists coach the caregiver on using the targeted strategies during these routines, encouraging caregivers to reflect on their implementation, and developing a plan to use the AAC strategies during activities not practiced during the intervention session. The AAC intervention is provided to families using an evidence-based service delivery model, Family Guided Routines Based Intervention.

Early Augmentative and Alternative Communication (AAC) Intervention

Eligibility Criteria

• Age: 24 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

1. Speech-Language Pathologists: 1. age \> 18 years 2. full or part-time employment providing language intervention to children 24 - 36 months with IDD 3. has at least 1 child on their caseload who uses AAC 4. has 2 or more years of experience providing AAC to children with IDD 5. able to speak, understand, and read English. 2. Caregivers: 1. age \> 18 years 2. parent, primary caregiver, or legal guardian of a child age 24 - 36 months with IDD 3. has at least 6 months of experience receiving early intervention, and 4. able to speak, understand, and read English. 3. Children: 1. age 24 - 36 months 2. diagnosis of IDD confirmed by caregiver or medical record 3. severe developmental delay, defined as a score of \> 2 standard deviations below the mean on the Mullen Scales of Early Learning (MSEL) Early Learning Composite 4. severe 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) 5. receptive vocabulary of at least 50 words, per caregiver report on MCDI-WG 6. use of intentional communication behaviors, defined as a score of \> 7 on the Communication Complexity Scale 7. sufficient motor skills to sit upright with support, interact with toys provided during the assessment, and access the AAC system 8. hearing within normal limits, defined as 0 to 25 dbHL in at least one ear 9. vision within normal limits, defined as 20/80 visual acuity or better in at least one eye, and 10. exposure to English in the home or community. 11. Children with uncontrolled seizure disorders will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Florida State University: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Speech; Language Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior; Communication Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Emily D. Quinn, Ph.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily D. Quinn, Ph.D.

CONTACT

503-494-2263; quinnem@ohsu.edu

Alexandria Cook, B.A.

CONTACT

503-494-5179; cooal@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Although this is a single-arm trial, outcome assessors will be masked to reduce potential for experimenter bias. We will also employ a technique for single-case experimental designs called masked visual analysis.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 24, 2023
• Study Start: July 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available one year after all of the data analysis is complete.
• Access Criteria: We will make the data and associated documentation available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant, (2) to secure the data using appropriate computer technology, (3) to destroy or return the data after analyses are completed, and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications.

Locations

US (1)