Relationships, Employment, Autonomy, and Life Satisfaction (REALS) Study

NCT04381195 | Completed

• 3 other identifiers: STUDY1908035511923R01HD100392
• Study Type: observational
• Target: 1,650
• Locations: 1 country
• Sites: 1

Brief Summary

One of the major methodological obstacles to more informed policies and programs to support the successful transition to adulthood in autism spectrum disorder (ASD) is the absence of suitable measures of meaningful outcomes for adults. Currently available options include (a) measures designed for children that largely fail to capture concepts pertinent in adulthood or (b) the use of broad, often dichotomous outcomes (e.g., employed or not) that are insufficiently sensitive for monitoring progress. The objective of this project is to develop efficient and validated proxy and self-report measures for autistic adults and adults with other IDD in the domains of relationships, employment, autonomy, and life satisfaction called the REALS. This study will build on prior success in applying methods from the Patient-Reported Outcomes Measurement Information System (PROMIS®) to measurement development in ASD and will utilize a national sample of 500 autistic adults capable of self-report and 500 caregivers of autistic adults representative of the entire range of speaking level.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Relationships, Employment, Autonomy and Life Satisfaction (REALS) Scale

  The completion of these aims will generate, for the first time, a reliable and valid measure of adulthood functioning in ASD that is efficient and broadly applicable across the full range of functioning.

  5 years

Study Arms (2)

Aim 1

Item Drafting and Revising (Aim 1). Together with a stakeholder panel of autistic adults and adults with IDD and parents/caregivers, the study investigators will generate an item pool based on the conceptual model.

Diagnostic Test: REALS Development

Aim 2

Item Calibration (Aim 2). Measures will be completed online and therefore the sample will include those with self-reported IDD or autism diagnoses and their caregivers (total n of 1000 each)

Diagnostic Test: REALS Testing

Interventions

REALS Development DIAGNOSTIC_TEST

Complete drafting of an item pool (adults with ASD, parents, adult service providers); Assign items to all parts of our conceptual framework to ensure sufficient construct coverage across employment, social, and independent living domains; and Conduct cognitive interviews with 25 caregivers of adults with ASD and 25 self-reporting adults with ASD.

Also known as: Develop and refine an item pool for measuring adult outcomes in ASD

Aim 1

REALS Testing DIAGNOSTIC_TEST

A national sample of proxy reporters (e.g., parents, clinicians, group home staff) for 1000 autistic adults and self-reporting autistic adults and adults with other IDD will complete the REALS draft items and a co-calibration battery to establish psychometrics, generate short-forms, and ensure applicability across adults with ASD.

Also known as: Derive caregiver and self-report short-forms that are reliable and valid

Aim 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Autistic adults, parents/caregivers of autistic adults, adults with IDD, parents/caregivers of adults with IDD

You may qualify if:

• adult age, defined as 18+ years old;
• professional diagnosis of ASD or caregiver of an adult with a professional diagnosis of ASD.
• age 18 years or older;
• caregiver of an autistic adult with at least weekly contact. For adults who cannot self-report, only caregiver report data on the REALS will be collected.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Autism Speaks: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Sound

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Carla Mazefsky, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 8, 2020
• Study Start: June 28, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data may be shared after study completion and publication.
• Access Criteria: The investigators of this study will review and determine which specific requests to analyze de-identified data from the SQL database by other researchers will be shared. Investigators will also share data in collaboration with NIH to facilitate de-identified data sharing activities for the National Database for Autism Research (NDAR).

Locations

US (1)