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Person-Centered Assessment and Monitoring Systems (PCAMS)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCAMS assessments
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

-Inability to provide consent

Sites / Locations

  • The Penn State College of Medicine

Outcomes

Primary Outcome Measures

Social Responsiveness Scale- 2
Adult Behavior Checklist
Additional PROMIS measures
Patient-Reported Outcomes Measurement Information System
Community Engagement measure

Secondary Outcome Measures

PROMIS measures
Patient-Reported Outcomes Measurement Information System
Elected Reporter Community Engagement measure

Full Information

First Posted
January 11, 2017
Last Updated
April 6, 2020
Sponsor
Milton S. Hershey Medical Center
Collaborators
Pennsylvania Bureau of Autism Services
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1. Study Identification

Unique Protocol Identification Number
NCT03019978
Brief Title
Person-Centered Assessment and Monitoring Systems
Acronym
PCAMS
Official Title
Person-Centered Assessment and Monitoring Systems (PCAMS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Pennsylvania Bureau of Autism Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
PCAMS assessments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Responsiveness Scale- 2
Time Frame
annually over 2 years
Title
Adult Behavior Checklist
Time Frame
annually over 2 years
Title
Additional PROMIS measures
Description
Patient-Reported Outcomes Measurement Information System
Time Frame
quarterly over 2 years
Title
Community Engagement measure
Time Frame
semi-annually over 2 years
Secondary Outcome Measure Information:
Title
PROMIS measures
Description
Patient-Reported Outcomes Measurement Information System
Time Frame
quarterly over 2 years
Title
Elected Reporter Community Engagement measure
Time Frame
semi-annually over 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -Inability to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Murray, M.D.
Organizational Affiliation
Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Person-Centered Assessment and Monitoring Systems

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