Recruiting

AAC Intervention

Sponsor:

Oregon Health and Science University

Code:

NCT05743439

Conditions

Intellectual Disability

Speech and Language Disorder

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Early Augmentative and Alternative Communication (AAC) Intervention

Study Details

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

Study ID

NCT05743439

Start date

Jul 1, 2022

Status verified date

Apr, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Change in Caregiver Use of AAC Intervention Strategies [ Time Frame: Assessed 1-2 times per week through study completion, 3-4 months. ]

Central Contacts and Locations

Central contacts

Emily D. Quinn, Ph.D.

503-494-2263quinnem@ohsu.edu

Alexandria Cook, B.A.

503-494-5179cooal@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Emily D Quinn, Ph.D

503-494-2263quinnem@ohsu.edu

Alexandria Cook, BA

503-494-5179cooal@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-05.