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

NCT ID: NCT03019952

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-04-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Care Coordination Visit

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pennsylvania Bureau of Autism Services

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Murray

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael J. Murray, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hershey Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00003849

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.