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Autism Spectrum DisorderPCAMSNCT03019978

Person-Centered Assessment and Monitoring Systems

A study testing PCAMS assessments in people with Autism Spectrum Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study will include an analysis of data for residents of Pennsylvania who are age 21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the Commonwealth's Adult Community Autism Program (ACAP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
PCAMS assessments
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 2016to Aug 2019
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrolled in Pennsylvania's Adult Community Autism Program (ACAP), > 18 years of age
  • English as primary language spoken
  • Ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level)
  • Have an Elected Reporter

Who cannot join

  • -Inability to provide consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Penn State College of Medicine

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Person-Centered Assessment and Monitoring Systems (PCAMS)

The proposed study will include an analysis of data for residents of Pennsylvania who are age 21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the program will be administered a standardized assessment battery quarterly for two years. The proposed study will analyze the data gathered during each of the assessment periods in order to aid in service/treatment planning, assess for individual improvements, and ultimately measure treatment outcomes.

Read the detailed description

The proposed study seeks to more closely monitor the changing needs and challenges of adults with ASD, which will be facilitated through a battery of assessments given over quarterly time points in a two year time period. Investigators seek to address whether increased frequency of behaviorally driven assessments will inform treatment. More specifically, investigators are interested in knowing if the assessment data influences treatment planning with providers or if it is guiding any decisions about treatment once data is returned to participants in a meaningful way which is easily understood. If data prompts treatment changes, the study will examine whether improvements are being shown months or even years later.

An "elected reporter", a family member, is asked to take part in the research study with the participant. An elected reporter is asked to complete several questionnaires quarterly, both reporting on themself and the participant.

Being tested
PCAMS assessments
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.

  • PCAMS assessmentsOther

    This is a longitudinal study, where data will be collected from 54 individuals who are already enrolled in Pennsylvania's ACAP program. Participants will be required to complete online assessments at baseline and then quarterly over a two-year time period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Responsiveness Scale- 2

    Measured: annually over 2 years

  2. Adult Behavior Checklist

    Measured: annually over 2 years

  3. Additional PROMIS measures

    Patient-Reported Outcomes Measurement Information System

    Measured: quarterly over 2 years

  4. Community Engagement measure

    Measured: semi-annually over 2 years

Secondary outcomes (2)

  1. PROMIS measures

    Patient-Reported Outcomes Measurement Information System

    Measured: quarterly over 2 years

  2. Elected Reporter Community Engagement measure

    Measured: semi-annually over 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study startJul 2016
  3. Primary completionAug 2019
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03019978
Sponsor's protocol ID
STUDY00004326
Acronym
PCAMS
Status last verified
Apr 2020
First submitted
11 Jan 2017
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PCAMS assessments in people with Autism Spectrum Disorder, run by Milton S. Hershey Medical Center 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 4 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 8 Apr 2020. 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?

Social Responsiveness Scale- 2 (time frame: annually over 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03019978.

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 8 Apr 2020.

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