Autism Spectrum DisorderREALSNCT04381195
Relationships, Employment, Autonomy, and Life Satisfaction (REALS) Study
An observational study of Autism Spectrum Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- REALS Development and REALS Testing
- How many people
- 1,650 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Autistic adults, parents/caregivers of autistic adults, adults with IDD, parents/caregivers of adults with IDD
Who may be able to join
- Across Aims, inclusion criteria are:
- adult age, defined as 18+ years old;
- 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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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:
- Complete drafting of an item pool with expert input (autistic adults, parents, adult service providers, researchers);
- Assign items to all parts of the conceptual framework to ensure sufficient construct coverage across employment, social, and independent living domains; and
- 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
- Being tested
- REALS Development, REALS Testing
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REALS DevelopmentDiagnostic test
Also called Develop and refine an item pool for measuring adult outcomes in ASD
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.
REALS TestingDiagnostic test
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Diagnostic Test: REALS Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start28 Jun 2021
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Autism Speaks
- Responsible party
- Principal investigator, Carla Mazefsky, University of Pittsburgh
- Investigators
- Carla Mazefsky, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381195
- Sponsor's protocol ID
- STUDY19080355
- Other IDs
- 11923, R01HD100392
- Acronym
- REALS
- Status last verified
- Apr 2025
- First submitted
- 1 May 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships, Employment, Autonomy, and Life Satisfaction - #REALSadultlife
- ClinicalTrials.gov ID
- NCT04381195
- Acronym / sponsor ID
- REALS / STUDY19080355
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Autism Speaks
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Complete drafting of an item pool with expert input (autistic adults, parents, adult service providers, researchers);
- Assign items to all parts of the conceptual framework to ensure sufficient construct coverage across employment, social, and independent living domains; and
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | – | Diagnostic Test: REALS DevelopmentItem 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. |
| Aim 2 | – | Diagnostic Test: REALS TestingItem 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Autistic adults, parents/caregivers of autistic adults, adults with IDD, parents/caregivers of adults with IDD
Key inclusion criteria (6 listed)
- adult age, defined as 18+ years old;
- 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
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REALS DevelopmentAlso: Develop and refine an item pool for measuring adult outcomes in ASDComplete 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. | Diagnostic test | Aim 1 |
| REALS TestingAlso: Derive caregiver and self-report short-forms that are reliable and validA 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. | Diagnostic test | Aim 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Mazefsky, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationships, Employment, Autonomy and Life Satisfaction (REALS) Scale (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.