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

NCT ID: NCT04381195

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2025-02-28

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.

Detailed Description

A major methodological obstacle to more informed policies to support autistic adults and adults with other intellectual and developmental disabilities (IDD) is the absence of suitable measures of outcomes for autistic adults. Landmark studies of adult outcome have traditionally classified individuals as having good, fair, or poor outcomes, a rating which has low reliability and is generally insensitive to treatment-related changes. Other studies have utilized adaptive behavior scales as functional outcome measures even though they were not designed for that purpose, such as the Vineland Adaptive Behavior Scales (VABS). Importantly, meaningful aspects of adult life are related to, but different than, adaptive function, with the former being the key endpoints of intervention (e.g., employment, friendships) and adaptive function representing important abilities (e.g., communication, ability to follow instructions) that contribute to improved outcomes. Further, the VABS and similar measures were originally developed for children to confirm disability status in school, and as such they have limited coverage of adult content. Therefore, there is an urgent need for sensitive and validated measures of adult outcomes.

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 speaking ability. The availability of such a measure is essential to inform and evaluate program development, understand individual-level factors associated with outcomes, and ultimately to develop actionable items to improve the transition to adulthood and adult life.

The objective of this project is to develop efficient and validated proxy and self-report measures or autistic adults and adults with other IDD -relationships, employment, autonomy, and life satisfaction called the REALS, and establish the validity of the REALS utilizing state-level service utilization data. This study will build on a previous study's success in applying methods from PROMIS® to measurement development in ASD.

Aim 1. Develop and refine an item pool. The REALS study will:

1. Complete drafting of an item pool with expert input (autistic adults, parents, adult service providers, researchers);

2. Assign items to all parts of the conceptual framework to ensure sufficient construct coverage across employment, social, and independent living domains; and

3. Conduct cognitive interviews with 25 caregivers of autistic adults and adults with other IDD and 25 self-reporting adults.

Aim 2. Establish the psychometrics of the REALS and derive caregiver and self-report short-forms that are reliable and valid. A national sample of proxy reporters (e.g., parents, clinicians, group home staff) for 500 adults with ASD representative of the full range of verbal and intellectual abilities and 500 self-reporting autistic adults will complete the REALS draft items and a co-calibration battery to establish psychometrics, generate short-forms, and ensure applicability across autistic adults.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

REALS Development

Intervention Type: 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.

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)

REALS Testing

Intervention Type: 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.

Interventions

REALS Development

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.

Intervention Type: DIAGNOSTIC_TEST

REALS Testing

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Develop and refine an item pool for measuring adult outcomes in ASD; Derive caregiver and self-report short-forms that are reliable and valid

Eligibility Criteria

Inclusion Criteria

1. adult age, defined as 18+ years old;

2. professional diagnosis of ASD or caregiver of an adult with a professional diagnosis of ASD.

1. age 18 years or older;

2. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Autism Speaks

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Carla Mazefsky

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Mazefsky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

11923

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R01HD100392

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19080355

Identifier Type: -

Identifier Source: org_study_id