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Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD (t-CARE)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Coordination Visit
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

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Between 14 and 19 years of age upon entry into t-CARE
  2. A primary diagnosis of Asperger's Syndrome or autism, as indicated by the Social Responsiveness Scale, Second Edition (SRS-2; Constantino & Gruber, 2012)
  3. English as primary language spoken
  4. Ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level) (self-report questions to be asked by study coordinator)

Exclusion Criteria:

  1. A significant language delay
  2. Significant psychosis as indicated through a semi-structured interview (Mini-International Neuropsychiatric Interview)

Sites / Locations

  • The Penn State College of Medicine

Outcomes

Primary Outcome Measures

Holmes and Rahe Stress Scale
SRS-2
Waisman Activities of Daily Living Scale
Intolerance of Uncertainty
PROMIS Multi-Domain 49
Temple University Community Participation (TUCP) measure
PROMIS proxy measures
PROMIS SF measures
Self-Determination Scale

Secondary Outcome Measures

Closure Survey

Full Information

First Posted
January 11, 2017
Last Updated
March 11, 2019
Sponsor
Milton S. Hershey Medical Center
Collaborators
Pennsylvania Bureau of Autism Services
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1. Study Identification

Unique Protocol Identification Number
NCT03019952
Brief Title
Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD
Acronym
t-CARE
Official Title
Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (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
An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April 2016. The individuals enrolled in the program will be administered a standardized assessment battery during each visit with the care coordinator or study coordinator. The proposed study will analyze data gathered during each of the assessment periods in order to check the efficacy and viability of the protocol.
Detailed Description
Current collaboration between individuals, families, and providers through in-person meetings are extremely infrequent, costly, and occur most often when providers are intimately involved as part of a multidisciplinary team in a single setting such as at a school. Often, little information is transmitted between providers and/or school personnel in determining treatment goals and interventions. Furthermore, the transmission of information is often provider to provider or school personnel to provider, which excludes direct patient-input and lessens transparency in decision making. In an effort to improve current care and therefore improve successful adult transitions for adolescents with ASD, t-CARE is designed to mimic multidisciplinary team meetings. These meetings are incredibly impactful as they include direct individual and family involvement through facilitated information-sharing, while also maintaining patient-centered care across multiple providers and complex systems of care.

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
52 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Care Coordination Visit
Intervention Description
This is a longitudinal study. Adolescents or young adults with autism will participate in this study. Participants will be required to complete a baseline of assessment measures at enrollment and then monthly assessments (described in the study procedures below) during the first (approximately) 10-15 minutes of each visit with the t-CARE coordinator. The remainder of the visit will focus on care coordination and clinical treatment goals.
Primary Outcome Measure Information:
Title
Holmes and Rahe Stress Scale
Time Frame
annually over 2 years
Title
SRS-2
Time Frame
annually over 2 years
Title
Waisman Activities of Daily Living Scale
Time Frame
annually over 2 years
Title
Intolerance of Uncertainty
Time Frame
annually over 2 years
Title
PROMIS Multi-Domain 49
Time Frame
monthly over 2 years
Title
Temple University Community Participation (TUCP) measure
Time Frame
quarterly over 2 years
Title
PROMIS proxy measures
Time Frame
quarterly over 2 years
Title
PROMIS SF measures
Time Frame
monthly over 2 years
Title
Self-Determination Scale
Time Frame
annually over 2 years
Secondary Outcome Measure Information:
Title
Closure Survey
Time Frame
after completion of 2 year study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 14 and 19 years of age upon entry into t-CARE A primary diagnosis of Asperger's Syndrome or autism, as indicated by the Social Responsiveness Scale, Second Edition (SRS-2; Constantino & Gruber, 2012) English as primary language spoken Ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level) (self-report questions to be asked by study coordinator) Exclusion Criteria: A significant language delay Significant psychosis as indicated through a semi-structured interview (Mini-International Neuropsychiatric Interview)
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

Learn more about this trial

Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD

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