Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05743439
Study type Interventional
Source Oregon Health and Science University
Contact Emily D. Quinn, Ph.D.
Phone 503-494-2263
Email quinnem@ohsu.edu
Status Recruiting
Phase N/A
Start date July 1, 2022
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT03644797 - Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs
Not yet recruiting NCT02881333 - Various Type of Genetic Events in Patients With Intellectual Disability N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT02746614 - Psychomotor Therapy Effects in Adaptive Behavior and Motor Proficiency in Intellectual Disability N/A
Completed NCT06097819 - Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities N/A
Recruiting NCT05767203 - Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin N/A
Terminated NCT05445596 - Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools N/A
Recruiting NCT05131425 - Facing Your Fears: Adolescents With ASD and Intellectual Disability N/A
Completed NCT04436692 - Dietary Intervention and Adults With Intellectual Disabilities N/A
Completed NCT04917666 - Process and Outcomes of Horticultural Therapy for People With Disabilities N/A
Completed NCT04518358 - Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills N/A
Completed NCT04554355 - Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability N/A
Completed NCT04277130 - Effectiveness of Active Video Games in Children With Intellectual Disabilities N/A
Enrolling by invitation NCT02914951 - Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability N/A
Completed NCT03989388 - Occupational Self-Analysis Programme N/A
Completed NCT02304302 - Down Syndrome Memantine Follow-up Study Phase 2