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Autism Spectrum Disordert-CARENCT03019952

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

A study testing Care Coordination Visit in people with Autism Spectrum Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Care Coordination Visit
How many people
52 participants
Where
1 siteUnited States
Study dates
Jan 2016to 9 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Penn State College of Medicine

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Read the 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.

Being tested
Care Coordination Visit
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care Coordination VisitBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Holmes and Rahe Stress Scale

    Measured: annually over 2 years

  2. SRS-2

    Measured: annually over 2 years

  3. Waisman Activities of Daily Living Scale

    Measured: annually over 2 years

  4. Intolerance of Uncertainty

    Measured: annually over 2 years

  5. PROMIS Multi-Domain 49

    Measured: monthly over 2 years

  6. Temple University Community Participation (TUCP) measure

    Measured: quarterly over 2 years

  7. PROMIS proxy measures

    Measured: quarterly over 2 years

  8. PROMIS SF measures

    Measured: monthly over 2 years

  9. Self-Determination Scale

    Measured: annually over 2 years

Secondary outcomes (1)

  1. Closure Survey

    Measured: after completion of 2 year study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study startJan 2016
  3. Primary completion9 Apr 2018
  4. Study completion9 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03019952
Sponsor's protocol ID
STUDY00003849
Acronym
t-CARE
Status last verified
Mar 2019
First submitted
11 Jan 2017
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Care Coordination Visit in people with Autism Spectrum Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Holmes and Rahe Stress Scale (time frame: annually over 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03019952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.

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t-CARE Clinical Trial NCT03019952 | AzTrials