NCT03019978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

3.1 years

First QC Date

January 11, 2017

Last Update Submit

April 6, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Social Responsiveness Scale- 2

    annually over 2 years

  • Adult Behavior Checklist

    annually over 2 years

  • Additional PROMIS measures

    Patient-Reported Outcomes Measurement Information System

    quarterly over 2 years

  • Community Engagement measure

    semi-annually over 2 years

Secondary Outcomes (2)

  • PROMIS measures

    quarterly over 2 years

  • Elected Reporter Community Engagement measure

    semi-annually over 2 years

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michael J Murray, M.D.

    Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations