Mobilizing Community Systems to Engage Families in Early Autism Spectrum Disorder (ASD) Detection & Services

NCT02445105 | Completed DMC

• 2 other identifiers: MH1044231R01MH104423-01
• Study Type: interventional
• Target: 10,857
• Locations: 1 country
• Sites: 4

Brief Summary

This multisite study will compare the effectiveness of universal screening by 3 community service systems using Autism Navigator, a highly interactive web platform that includes an automated screening tool, information about autism for families, and a professional development course on the early signs of autism and effective evidence-based practice with extensive video footage to rapidly build the capacity for early detection. The investigators will also conduct a multisite pragmatic randomized clinical trial to test the effectiveness of an evidence-based Family Engagement Intervention compared to Autism Navigator Enhanced Practice implemented by the 3 community service systems with children who have a positive autism screen to increase the number of children who are screened, referred for evaluation, receive a diagnosis, and receive community-based EI between 18-27 months of age. This study will impact family engagement in community screening and diagnosis by demonstrating the effectiveness of brief manualized engagement interventions. Findings will advance science by providing researchers with a method for recruiting a community sample, allowing for research at younger ages, which could accelerate science.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Number of children screened by community service provider

  This is a tally of the number of children screened by each provider and then summed.

  9 to 36 months of age

• Child age at screening by community service provider

  This is the age of the child at the time of screening in months.

  9 to 36 months of age

• Child age at referral for evaluation by community service provider

  This is the age that the child is referred by the provider for an evaluation in months.

  9 to 36 months of age

• Child age at entry into intervention

  This is the age that the child enters and begins early intervention in months.

  9 to 36 months of age

Secondary Outcomes (6)

• Child autism symptoms measured with the Autism Diagnostic Observation Schedule

  when child is 27 and 36 months of age

• Child developmental level measured with the Mullen Scales of Early Learning

  when child is 27 and 36 months of age

• Child adaptive behavior measured with the Vineland Adaptive Behavior Scales

  when child is 27 and 36 months of age

• Family measure of resources measured with Family Resource Scale completed by parent

  when child is 27 and 36 months of age

• Family measure of stress measured with Parenting Stress Index completed by parent

  when child is 27 and 36 months of age

Study Arms (2)

Autism Navigator Enhanced Practice

ACTIVE COMPARATOR

A 6-hour training will be provided to community service providers with the Autism Navigator for Primary Care professional development course and use of a web-based platform that includes an automated communication and autism screening and monthly electronic monitoring.

Behavioral: Autism Navigator Enhanced Practice

Family Engagement plus Autism Navigator

EXPERIMENTAL

A 6-hour training will be provided to community service providers on the use of Motivational Interviewing, an evidence-based counseling method to improve engagement of families who are ambivalent about screening or intervention for their toddler, in addition to Autism Navigator Enhanced Practice.

Behavioral: Family Engagement plus Autism Navigator

Interventions

Autism Navigator Enhanced Practice BEHAVIORAL

Community service providers will receive training in Autism Navigator for Primary Care, a 6-hour online professional development course with extensive video illustration of the early signs of autism in toddlers, collaborating with families, developmental milestones, screening and referral practices, and early intervention basics. This web-based platform includes an automated screening for communication delay and autism, an automated monthly electronic monitoring, and digital tools for families to address practical obstacles to screening toddlers 9-18 months of age and referral to early intervention.

Autism Navigator Enhanced Practice

Family Engagement plus Autism Navigator BEHAVIORAL

Community service providers will receive a 6-hour training on the use of Motivational Interviewing, an evidence-based counseling method to improve engagement of families who are ambivalent about screening or intervention for their toddler. Community service providers will also receive a 6-hour training with the Autism Navigator for Primary Care professional development course and use of the web-based platform that includes an automated communication and autism screening and monthly electronic monitoring to address practical obstacles to screening toddlers 9-18 months of age and referral to early intervention.

Family Engagement plus Autism Navigator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Community service providers will be recruited from the specific catchment areas of the 4 sites in Florida, Georgia, New York, and Pennsylvania from 3 different community service systems:
• primary care including private, public, and military health care agencies and federally qualified health centers;
• federal programs including Women, Infants, and Children (WIC) Food and Nutrition Service, Early Head Start, and other social programs supporting low-income families; and
• the National Black Church Initiative (NBCI) and other religious networks serving minorities.
• Children are screened between 9 and 18 months of age by these community service providers who have agreed to be in this study and their families.

Sponsors & Collaborators

• Florida State University: lead
• Emory University: collaborator
• Weill Medical College of Cornell University: collaborator
• Drexel University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Florida State University

Tallahassee, Florida, 32303, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Amy M Wetherby, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Professor

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: May 15, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

US (4)