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OpenTrials
Completed

NCT Number: NCT03019952

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

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.

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Holmes and Rahe Stress Scale

    Time frame: annually over 2 years

  2. SRS-2

    Time frame: annually over 2 years

  3. Waisman Activities of Daily Living Scale

    Time frame: annually over 2 years

  4. Intolerance of Uncertainty

    Time frame: annually over 2 years

  5. PROMIS Multi-Domain 49

    Time frame: monthly over 2 years

  6. Temple University Community Participation (TUCP) measure

    Time frame: quarterly over 2 years

  7. PROMIS proxy measures

    Time frame: quarterly over 2 years

  8. PROMIS SF measures

    Time frame: monthly over 2 years

  9. Self-Determination Scale

    Time frame: annually over 2 years

Secondary outcomes

  1. Closure Survey

    Time frame: after completion of 2 year study

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Pennsylvania Bureau of Autism Services

Registry information

Acronym: t-CARE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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