NCT05425277

Brief Summary

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of a brief, inexpensive training on EI providers' ability to deliver an evidence-based, caregiver-mediated intervention that can improve providers' comfort and effectiveness in working with families of children with social communication concerns, as well as improving child and family outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

November 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

June 12, 2022

Last Update Submit

November 19, 2024

Conditions

Keywords

ASDAutism

Outcome Measures

Primary Outcomes (7)

  • Child Social Communication - In Vivo

    Change in in-vivo observation of child social communication will be assessed using the scored social communication items on the TELE-ASD-PEDS (TAP; Corona et al., 2021). There are 5 social communication items that can be scored 1-3 (range 5-15, with lower scores indicating better outcome).

    Change from baseline to 6-month follow-up

  • Child Social Communication - Parent Report

    Change in parent reported child social communication will be assessed using three subscales from the the Parent Interview for Autism-Clinical Version (PIA-CV; Stone et al., 2003).The subscales that will be examined are: Social Relating (17 questions), Language Understanding (7 questions), and Nonverbal Communication (13 questions). These items can be scored 1-5 (range 37-185, with higher scores indicating better outcome).

    Change from baseline to 6-month follow-up

  • Child Social Communication - Behaviorally Coded

    Change in behaviorally coded child social communication will be assessed using the observationally coded Weighted Frequency of Intentional Communication during a parent-child free play task (Yoder et al., 2009).

    Change from baseline to 6-month follow-up

  • Child Motor Imitation - In Vivo

    Change in behaviorally observed motor imitation will be assessed using an adapted version of the Motor Imitation Scale (MIS; Stone et al., 1997). Five items with three trials each will be presented to the child. If a child receives a maximum score, the item is discontinued. Each trial can be scored 0-2 (range 0-10, with higher scores indicating better outcome).

    Change from baseline to 6-month follow-up

  • Child Motor Imitation - Parent Report

    Change in parent reported motor imitation will be assessed using the Parent Interview for Autism-Clinical Version (PIA-CV; Stone et al., 2003). The Imitation subscale (4 items) will be examined. These items can be scored 1-5 (range 4-20, with higher scores indicating better outcome).

    Change from baseline to 6-month follow-up

  • Provider Coaching of Caregivers in RIT Strategies

    Change in providers' use of caregiver coaching strategies will be assessed via provider self-report survey.

    Change from baseline to 12-month follow-up

  • Caregiver Use of RIT Strategies

    Change in caregiver use of RIT strategies will be assessed via a caregiver-child activity in which caregivers are instructed to demonstrate the skills they learned from their (enrolled) EI provider; scoring will employ the RIT Fidelity Checklist (range 6-30, with higher scores indicating higher fidelity to RIT).

    Change from baseline to 6-month follow-up

Secondary Outcomes (5)

  • Child Adaptive Behavior

    Change from baseline to 6-month follow-up

  • Child Language

    Change from baseline to 6-month follow-up

  • Parenting Self-Efficacy

    Change from baseline to 6-month follow-up

  • Parenting Stress

    Change from baseline to 6-month follow-up

  • Caregiver Top Concerns

    Change from baseline to 6-month follow-up

Study Arms (2)

RIT Training Group

EXPERIMENTAL

Providers in the RIT group (n=30) will receive an 8-hour virtual workshop (2 half-days) on RIT implementation and caregiver coaching. Each provider will invite 2 families in their caseload to participate in the study. Providers will coach families in the use of RIT. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity.

Behavioral: Reciprocal Intervention Teaching (RIT)

Daily Routines

ACTIVE COMPARATOR

Providers in the Routines Control group (n=30) will receive a 3-hour virtual workshop focused on helping providers coach caregivers on how to increase children's participation and social engagement during everyday home routines (i.e., snack time, bedtime, bath time, and family playtime). Each provider will invite 2 families in their caseload to participate in the study. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity to ensure contamination has not occurred and the control condition providers are not utilizing RIT strategies.

Behavioral: Daily Routines

Interventions

RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and initiating joint attention during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal social-communicative skills. RIT is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by caregivers and siblings.

RIT Training Group
Daily RoutinesBEHAVIORAL

The Routines webinar was adapted from a web-based tutorial developed by PI Stone and colleagues (Ibanez et al., 2018). The webinar covers topics such as why everyday routines are important, especially for children with ASD, specific steps for increasing children's participation in routines, and how to use strategies such as visual supports to clarify expectations, and provides numerous video examples of caregivers using different strategies. Providers are also given access to a video library of caregivers using the Daily Routines strategies with their children, as well as a workbook to use with families during treatment.

Daily Routines

Eligibility Criteria

Age18 Months - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • EI Providers:
  • Speak and read English
  • Work at a participating Part C practice or agency
  • Have an active caseload that includes at least two children with ASD or suspected ASD
  • Are willing to invite families to participate in this study
  • Caregivers and Toddlers (recruited from EI provider caseloads):
  • Caregivers speak and read English or Spanish
  • Caregivers are at least 18 years of age
  • Caregivers are willing and able to participate in intervention sessions and research tele-visits that are video-recorded by research staff
  • Child receives services from one of the participating agencies and attends regular sessions with the enrolled provider
  • Child is between 18 and 30 months of age at study entry
  • Child has a diagnosis of ASD or displays social communication impairments consistent with ASD

You may not qualify if:

  • Child has no severe visual, auditory, or physical impairments and no serious medical, genetic, or neurological conditions that would impede their ability to engage in RIT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wendy L Stone, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, College of Arts & Sciences: Psychology

Study Record Dates

First Submitted

June 12, 2022

First Posted

June 21, 2022

Study Start

May 15, 2021

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

November 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations