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

Intellectual Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743439
• Other study ID #: STUDY00021611
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Emily D. Quinn, Ph.D.
• Phone: 503-494-2263
• Email: quinnem[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disability
• Language Disorders
• Speech and Language Disorder

Intervention

Behavioral:
• Early Augmentative and Alternative Communication (AAC) Intervention
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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Acceptability of Intervention Measure (AIM)	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.	Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months
Other	Change in Intervention Appropriateness Measure (IAM)	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.	Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months
Other	Change in Feasibility of Intervention Measure (FIM)	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.	Measured weekly during baseline, intervention, and post-intervention. Through study completion, 3-4 months
Other	Change in Communication Complexity Scale (CCS; Aim 3 Only)	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.	Study entry (start of study) and post-intervention (3-4 months later)
Other	Change in Communication Matrix (Aim 3 Only)	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.	Study entry (start of study) and post-intervention (3-4 months later)
Other	Change in Preschool-Language Scales 5th Edition (Aim 3 Only)	Standardized Assessment of expressive and receptive language skills. The metric is the total standard score with a mean of 100 and SD of 15	Study Entry (start of study) and Post Intervention (3-4 months later)
Primary	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	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.	Assessed 1-2 times per week through study completion, 3-4 months.