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

Primary Purpose

Intellectual Disability, Speech and Language Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Augmentative and Alternative Communication (AAC) Intervention
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability

Eligibility Criteria

24 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early Augmentative and Alternative Communication (AAC) Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Number of Child Communication Acts
Observational measure of a child's expressive communication behaviors including gestures, vocalizations, spoken words, manual signs, and picture symbols during a 15-min caregiver-child interaction. The secondary dependent variable is the number of child communication acts expressed. The metric is a frequency count of total child communication acts.

Full Information

First Posted
February 13, 2023
Last Updated
February 22, 2023
Sponsor
Oregon Health and Science University
Collaborators
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT05743439
Brief Title
Early Augmentative and Alternative Communication (AAC) Intervention Delivered Via Hybrid Telehealth
Official Title
Early Augmentative and Alternative Communication (AAC) Intervention Delivered Via Hybrid Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Aim 1: Determine stakeholders' preferences and needs for two key AAC intervention components: (a) service delivery and (b) strategies to enhance treatment adherence. Researchers will conduct and analyze interviews with ten caregivers and ten speech-language pathologists (SLPs) to assess the acceptability of different service delivery models (e.g., in person, telehealth, hybrid). Interviews will also focus on identifying strategies (e.g., text-message reminders, video modeling) with the potential to support caregivers' adherence and promote generalization to new activities. Results will inform AAC intervention development (Aim 2). Aim 2: Develop an AAC intervention through iterative testing cycles. Researchers will conduct six multiple-baseline designs to investigate the effects of an AAC intervention on caregivers' AAC intervention strategy use (primary outcome) and children's communication acts (secondary outcome). Six caregiver-child dyads will receive 24 in-person intervention sessions, during which the therapist will teach caregivers to use AAC and language facilitation strategies during family-selected routines. Social validity will be assessed via weekly questionnaires and a post-intervention interview. In this experiment, the feasibility of in-person delivery is investigated to establish the acceptability and effects of the intervention procedures before pilot testing hybrid delivery. Results will inform modifications which will be tested in a hybrid delivery model (Aim 3). Aim 3: Conduct a pilot test of a hybrid telehealth AAC intervention. Researchers will employ a combination multiple probe design to investigate the feasibility of a hybrid telehealth AAC intervention. Nine caregiver-child dyads will receive 24 intervention sessions (8 in-person, 16 telehealth) which include coaching on AAC and language facilitation strategies. The investigators hypothesize that the intervention will increase caregivers' AAC intervention strategy use (primary outcome) and children's communication acts (secondary outcome). Child communication outcomes and caregivers' social validity assessments will be explored to inform a future large-scale trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Speech and Language Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Augmentative and Alternative Communication (AAC) Intervention
Arm Type
Experimental
Arm Description
After a period of stable baseline performance (3 to 5 sessions) on parent and child outcomes, the interventionist will apply the early AAC intervention.
Intervention Type
Behavioral
Intervention Name(s)
Early Augmentative and Alternative Communication (AAC) Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Caregiver Use of AAC Intervention Strategies
Description
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).
Time Frame
Assessed 1-2 times per week through study completion, 3-4 months.
Secondary Outcome Measure Information:
Title
Change in Number of Child Communication Acts
Description
Observational measure of a child's expressive communication behaviors including gestures, vocalizations, spoken words, manual signs, and picture symbols during a 15-min caregiver-child interaction. The secondary dependent variable is the number of child communication acts expressed. The metric is a frequency count of total child communication acts.
Time Frame
Assessed 1-2 times per week through study completion, 3-4 months.
Other Pre-specified Outcome Measures:
Title
Change in Acceptability of Intervention Measure (AIM)
Description
Informant-reported measure of the acceptability of an intervention and/or implementation strategy. This four item questionnaire is administered to determine the extent to which stakeholders believe an intervention (e.g., AAC intervention) or implementation strategy (e.g., training, coaching) is acceptable. This measure was designed to be pragmatic, and adapted to an intervention, organization, or population. This measure has substantive and discriminant content validity, structural validity (Cronbach's alpha = 0.85) and test-test reliability (Cronbach's alpha = 0.83). The metric is a total score with a range of 4 - 20. Higher scores indicate greater acceptability.
Time Frame
Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months
Title
Change in Intervention Appropriateness Measure (IAM)
Description
Informant-reported measure of the appropriateness of an intervention and/ or implementation strategy. This four item questionnaire is administered to determine the extent to which stakeholders believe an intervention (e.g., AAC intervention) or implementation strategy (e.g., training, coaching) is appropriate. The measure was designed to be pragmatic, and adapted to an intervention, organization, or population. This measure has substantive and discriminant content validity, structural validity (Cronbach's alpha = 0.91) and test-test reliability (Cronbach's alpha = 0.87). The metric is a total score with a range of 4 - 20. Higher scores indicate greater appropriateness.
Time Frame
Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months
Title
Change in Feasibility of Intervention Measure (FIM)
Description
Informant-reported measure of the feasibility of an intervention and/or implementation strategy. This four item questionnaire is administered to determine the extent to which stakeholders believe an intervention (e.g., AAC intervention) or implementation strategy (e.g., training, coaching) is feasible. The measure was designed to be pragmatic, and adapted to an intervention, organization, or population. This measure has substantive and discriminant content validity, structural validity (Cronbach's alpha = 0.89) and test-test reliability (Cronbach's alpha = 0.88). The metric is a total score with a range of 4 - 20. Higher scores indicate greater feasibility.
Time Frame
Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months
Title
Change in Communication Complexity Scale (CCS; Aim 3 Only)
Description
Scripted assessment protocol with activities designed to elicit forms of communication. This assessment is used to describe the expressive communication skills of individuals who communicate using pre-symbolic and early symbolic behaviors. The CCS has adequate inter-observer agreement(k = 0.83), test-retest reliability ( r = 0.84), and concurrent validity with the Vineland II Expressive Communication Subscale (r = 0.47. The metric is the total optimal score with a range of 0 - 12. Higher scores indicate greater communication skills.
Time Frame
Study entry (start of study) and post-intervention (3-4 months later)
Title
Change in Communication Matrix (Aim 3 Only)
Description
Assessment consisting of 24 questions to describe early expressive communication skills of individuals who primarily communicate using pre-symbolic and early symbolic behaviors. This Communication Matrix has high inter-rater reliability (0.96). The metric is a total score with a range of 0 - 160. Higher scores indicate greater communication skills.
Time Frame
Study entry (start of study) and post-intervention (3-4 months later)
Title
Change in Preschool-Language Scales 5th Edition (Aim 3 Only)
Description
Standardized Assessment of expressive and receptive language skills. The metric is the total standard score with a mean of 100 and SD of 15
Time Frame
Study Entry (start of study) and Post Intervention (3-4 months later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Speech-Language Pathologists: age > 18 years full or part-time employment providing language intervention to children 24 - 36 months with IDD has at least 1 child on their caseload who uses AAC has 2 or more years of experience providing AAC to children with IDD able to speak, understand, and read English. Caregivers: age > 18 years parent, primary caregiver, or legal guardian of a child age 24 - 36 months with IDD has at least 6 months of experience receiving early intervention, and able to speak, understand, and read English. Children: age 24 - 36 months diagnosis of IDD confirmed by caregiver or medical record 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 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) receptive vocabulary of at least 50 words, per caregiver report on MCDI-WG use of intentional communication behaviors, defined as a score of > 7 on the Communication Complexity Scale sufficient motor skills to sit upright with support, interact with toys provided during the assessment, and access the AAC system hearing within normal limits, defined as 0 to 25 dbHL in at least one ear vision within normal limits, defined as 20/80 visual acuity or better in at least one eye, and exposure to English in the home or community. Children with uncontrolled seizure disorders will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily D. Quinn, Ph.D.
Phone
503-494-2263
Email
quinnem@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandria Cook, B.A.
Phone
503-494-5179
Email
cooal@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily D. Quinn, Ph.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily D Quinn, Ph.D
Phone
503-494-2263
Email
quinnem@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Alexandria Cook, BA
Phone
503-494-5179
Email
cooal@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The final data set will include caregiver and SLP interview transcripts, standardized cognitive and language assessments, caregiver-reported demographic and behavioral data, observational data of the children in their caregivers at home over time and social validity questionnaires. This data set will be stripped of identifiers prior to release for sharing. 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.
IPD Sharing Time Frame
Data will be available one year after all of the data analysis is complete.
IPD Sharing 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.

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

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