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

February 5, 2024 updated by: Carla Mazefsky, University of Pittsburgh

Relationships, Employment, Autonomy, and Life Satisfaction - #REALSadultlife

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

Across Aims, inclusion criteria are:

  1. adult age, defined as 18+ years old;
  2. professional diagnosis of ASD or caregiver of an adult with a professional diagnosis of ASD.

Inclusion criteria for caregivers of adults with ASD will be

  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.

Exclusion Criteria:

Because the goal is to refine the items and ensure coverage of all relevant constructs, the investigators will seek a broad sample to support generalizability and representativeness (there will be no exclusion criteria).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Develop and refine an item pool for measuring adult outcomes in 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)
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.
Other Names:
  • Derive caregiver and self-report short-forms that are reliable and valid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationships, Employment, Autonomy and Life Satisfaction (REALS) Scale
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carla Mazefsky, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY19080355
  • 11923 (Other Grant/Funding Number: Autism Speaks)
  • R01HD100392 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing will occur at two levels:

  1. specific requests to analyze de-identified data from the SQL database and
  2. collaboration with NIH to facilitate de-identified data sharing activities for the National Database for Autism Research (NDAR). The investigators will establish final plans for data sharing procedures that are compliant with NIH policy, the Freedom of Information Act, the DHHS Privacy Rule, HIPPA, and the University of Pittsburgh Institutional Review Board (IRB) regulations and will vet all requests for data.

IPD Sharing Time Frame

Data may be shared after study completion and publication.

IPD Sharing 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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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