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

NCT03019952 | Completed

• 1 other identifier: STUDY00003849
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (9)

• Holmes and Rahe Stress Scale

  annually over 2 years

• SRS-2

  annually over 2 years

• Waisman Activities of Daily Living Scale

  annually over 2 years

• Intolerance of Uncertainty

  annually over 2 years

• PROMIS Multi-Domain 49

  monthly over 2 years

• Temple University Community Participation (TUCP) measure

  quarterly over 2 years

• PROMIS proxy measures

  quarterly over 2 years

• PROMIS SF measures

  monthly over 2 years

• Self-Determination Scale

  annually over 2 years

Secondary Outcomes (1)

• Closure Survey

  after completion of 2 year study

Interventions

Care Coordination Visit BEHAVIORAL

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.

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Pennsylvania Bureau of Autism Services: collaborator

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, Pervasive; Neurodevelopmental Disorders; Mental 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: January 1, 2016
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (1)