Partnering With Autistic Adults to Improve Healthcare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579669
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
National Institute of Mental Health (NIMH)
Syracuse University
Indiana University
Autistic Self Advocacy Network
Portland State University
Information provided by (Responsible Party):
Christina M. Nicolaidis, Oregon Health and Science University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Autism Spectrum Disorder
Intervention: Behavioral: Use of toolkit

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited autistic adults via fliers, postings, and announcements targeted to autism and disability-related list-serves, organizations, and forums. We invited the autistic adult's primary care providers (PCPs) to participate if the patient gave permission for us to contact their provider and provided usable contact information.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The total number of participants enrolled includes everyone who consented to participate. Some participants clicked "yes" to the online consent, but did not participate in the initial survey. The number of participants noted as Started in the Participant Flow module includes only those that took the initial survey.

Reporting Groups
Autistic Adults Adults on the autism spectrum
Primary Care Providers Participants' primary care providers

Participant Flow:   Overall Study
    Autistic Adults   Primary Care Providers
STARTED   170   41 
COMPLETED   134   41 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are presented for the autistic participants who completed the pre-intervention survey and the primary care providers who completed the PCP survey.

Reporting Groups
Autistic Adults Adults on the autism spectrum
Primary Care Providers Primary care providers taking care of autistic adults participating in this study
Total Total of all reporting groups

Baseline Measures
   Autistic Adults   Primary Care Providers   Total 
Overall Participants Analyzed 
[Units: Participants]
 170   41   211 
[Units: Years]
Mean (Full Range)
 (18 to 68) 
 (28 to 62) 
 (18 to 68) 
Gender, Customized 
[Units: Participants]
Male   75   15   90 
Female   91   25   116 
Other   4   0   4 
Not Reported   0   1   1 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   11   1   12 
Not Hispanic or Latino   158   36   194 
Unknown or Not Reported   1   4   5 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   2   0   2 
Asian   2   3   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   1   6 
White   152   29   181 
More than one race   5   2   7 
Unknown or Not Reported   4   6   10 
Region of Enrollment 
[Units: Participants]
United States   170   41   211 

  Outcome Measures

1.  Primary:   Patient Satisfaction   [ Time Frame: 1 month after use of toolkit ]

2.  Secondary:   Provider Satisfaction   [ Time Frame: 1-2 months after patient uses toolkit ]

3.  Secondary:   Patient Use of Toolkit Components   [ Time Frame: 1 month after use of toolkit ]

4.  Secondary:   Change in Patient Satisfaction With Healthcare   [ Time Frame: before and 1 month after use of toolkit ]

5.  Secondary:   Change in Patient's Perceived Barriers to Healthcare   [ Time Frame: Before and 1 month after use of toolkit ]

6.  Secondary:   Change in Patient Healthcare Self-Efficacy   [ Time Frame: Before and 1 month after use of toolkit ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was designed as a single-arm trial to assess feasibility and acceptability and to explore potential mechanisms of action. As such, there was no control group. PCPs are not a separate arm, but were included to assess acceptability.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Christina Nicolaidis, MD, MPH
Organization: Portland State University
phone: 5037259603

Responsible Party: Christina M. Nicolaidis, Oregon Health and Science University Identifier: NCT01579669     History of Changes
Other Study ID Numbers: R34MH092503 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2012
First Posted: April 18, 2012
Results First Submitted: August 18, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015