NCT02409303

Brief Summary

This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
627

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

March 26, 2015

Last Update Submit

November 1, 2022

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderScreeningPreventive interventionRisk

Outcome Measures

Primary Outcomes (6)

  • Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention

    PCP self-report

    5 times over 4 years

  • Change in rates of referral for early intervention services by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention

    PCP self-report

    5 times over 4 years

  • Change in percent of toddlers at risk for ASD recieving ASD-specialized behavioral intervention before 24 months from baseline (pre-SRT intervention) to post-SRT intervention

    Caregiver report

    Every 3 months until toddlers turn 36 months of age

  • Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention

    Caregiver report

    Every 3 months until toddlers turn 36 months of age

  • Change in levels of parenting stress, parenting efficacy, health quality of life, and satisfaction with the healthcare system from baseline (pre-SRT intervention) to post-SRT intervention

    Caregiver self-report

    Every 3 months until children turn 36 months of age

  • Change in levels of pivotal social-communicative behaviors in toddlers at risk for ASD from baseline (pre-SRT intervention) to post-SRT intervention

    Caregiver report

    Every 3 months until children turn 36 months of age

Study Arms (2)

Screen-Refer-Treat Intervention

EXPERIMENTAL

PCPs and EI Providers receive training workshops on validated, evidence-based practices (i.e., Online M-CHAT-R/F, STAT, and RIT) and then receive TA (i.e., Screen-Refer-Treat Intervention). At the county level, providers are randomized to the order/timing at which they will receive this system intervention

Behavioral: Screen-Refer-Treat Intervention

Control

NO INTERVENTION

No intervention received.

Interventions

Screen-Refer-Treat InterventionBEHAVIORAL

This intervention is healthcare system intervention that trains providers on validated screening tools (Online M-CHAT-R/F and STAT) and an evidence-based behavioral intervention (RIT). PCPs receive a 2-hour training workshop on the Online M-CHAT-R/F and EI Providers receive 2 day-long training workshops, one on the STAT/expedited assessment and one RIT.

Screen-Refer-Treat Intervention

Eligibility Criteria

Age16 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PCPs:
  • PCPs must work at a participating primary care practice.
  • EI Providers:
  • EI providers must work at a participating early intervention agency.
  • Caregivers and Toddlers:
  • To be categorized as part of the ASD Concerns Sample recruited from PCP offices:
  • Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; or (4) screening positive for ASD on a validated screening tool.
  • Toddlers must be between 16-20 months of age
  • To be categorized as part of the No ASD Concerns Sample recruited from PCP offices:
  • \- Toddlers must be between 16-20 months of age
  • To be categorized as part of the ASD Dx/ASD Concerns Sample recruited from EI agencies:
  • Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; (4) screening positive for ASD on a validated screening tool; or (5) parent-report of an ASD diagnosis.
  • Toddlers must be between 16-30 months of age

You may not qualify if:

  • reports that the toddler has any severe visual, auditory, or physical impairments, and/or serious medical, genetic, or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • Tagavi DM, Dick CC, Attar SM, Ibanez LV, Stone WL. The implementation of the screening tool for autism in toddlers in Part C early intervention programs: An 18-month follow-up. Autism. 2023 Jan;27(1):173-187. doi: 10.1177/13623613221086329. Epub 2022 Apr 11.

    PMID: 35403446DERIVED

  • Steinman KJ, Stone WL, Ibanez LV, Attar SM. Reducing Barriers to Autism Screening in Community Primary Care: A Pragmatic Trial Using Web-Based Screening. Acad Pediatr. 2022 Mar;22(2):263-270. doi: 10.1016/j.acap.2021.04.017. Epub 2021 Apr 23.

    PMID: 33901728DERIVED

  • Ibanez LV, Stoep AV, Myers K, Zhou C, Dorsey S, Steinman KJ, Stone WL. Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design. BMC Psychiatry. 2019 Jun 7;19(1):169. doi: 10.1186/s12888-019-2150-3.

    PMID: 31174514DERIVED

MeSH Terms

Conditions

Autism Spectrum 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
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 6, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

US(1)