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

NCT ID: NCT05743439

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Intellectual Disability; Speech and Language Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Augmentative and Alternative Communication (AAC) Intervention

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

Group Type: EXPERIMENTAL

Early Augmentative and Alternative Communication (AAC) Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Children with uncontrolled seizure disorders will be excluded.

• Minimum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Emily Quinn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily D. Quinn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emily D. Quinn, Ph.D.

Role: CONTACT

quinnem@ohsu.edu

503-494-2263

Alexandria Cook, B.A.

Role: CONTACT

cooal@ohsu.edu

503-494-5179

Facility Contacts

Emily D Quinn, Ph.D

Role: primary

quinnem@ohsu.edu

503-494-2263

Alexandria Cook, BA

Role: backup

cooal@ohsu.edu

503-494-5179

Other Identifiers

STUDY00021611

Identifier Type: -

Identifier Source: org_study_id