- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019978
Person-Centered Assessment and Monitoring Systems (PCAMS)
Person-Centered Assessment and Monitoring Systems (PCAMS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- The Penn State College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Responsiveness Scale- 2
Time Frame: annually over 2 years
|
annually over 2 years
|
|
|
Adult Behavior Checklist
Time Frame: annually over 2 years
|
annually over 2 years
|
|
|
Additional PROMIS measures
Time Frame: quarterly over 2 years
|
Patient-Reported Outcomes Measurement Information System
|
quarterly over 2 years
|
|
Community Engagement measure
Time Frame: semi-annually over 2 years
|
semi-annually over 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS measures
Time Frame: quarterly over 2 years
|
Patient-Reported Outcomes Measurement Information System
|
quarterly over 2 years
|
|
Elected Reporter Community Engagement measure
Time Frame: semi-annually over 2 years
|
semi-annually over 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael J Murray, M.D., Hershey Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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