Autism Spectrum DisorderNCT04186364
Autism Spectrum Ambassador Program (ASAP) in the ED
A study testing Assigned Ambassador in people with Autism Spectrum Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The investigators are evaluating the implementation and the effectiveness of a medical student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder coming into Penn State Hershey Children's Hospital Emergency Department. Read more about this study
- Who is it for?
- Ages 30 months to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Assigned Ambassador
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 8 Apr 2021
- 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 30 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Study Participants:
- Must be children 30 months to 17 years of age.
- Study participants will be boys and girls.
- Study participants will have a a diagnosis of Autism Spectrum Disorder.
- Study participants will be presenting through the pediatric emergency room at the Penn State Hershey Medical Center.
- Study participants must be English Speaking.
Show all 9Show fewer
- 2. Medical Student Ambassadors:
- Ambassadors must be enrolled as first, second, third, or fourth year medical students at the Penn State College of Medicine
- Ambassadors must complete training successfully
Who cannot join
- 1. Study Participants:
- Children under 30 months or older than 17 years.
- Children who do not have a diagnosis of Autism Spectrum Disorder.
- Children who cannot understand and communicate in English.
- 2. Medical Student Ambassadors:
- Individuals who are not a medical student at the Penn State College of Medicine.
- Medical students who do not complete the training course.
- Medical students who are not deemed appropriate the ASAP Ambassador role as per the discretion of study personnel.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Implementation and Evaluation of the Autism Spectrum Ambassador Program
The investigators are evaluating the implementation and the effectiveness of a medical student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder coming into Penn State Hershey Children's Hospital Emergency Department. The ASAP program involves training and assigning a medical student as an Ambassador to help advocate for the special needs of a child with ASD. This study is designed to compare patient satisfaction of children and families who are assigned an Ambassador to those who are not assigned an Ambassador during their time in the Emergency Department. The secondary objectives are to measure overall medical student satisfaction with the program, medical student career interests before and after participation, and medical student comfort level interacting with children with ASD before and after participation.
Read the detailed description
The Autism Spectrum Ambassador Program (ASAP) is a medical student staffed program designed to improve the experience for children with Autism Spectrum Disorder coming into the Children's Hospital Emergency Department (ED) for an acute visit. This program will pair an interested and trained medical student with a family whose child presents to the Children's Hospital ED and identifies as having Autism and requiring special accommodations to improve cooperation and procedure tolerance.
Patients will be identified by the study team members, who are ages 30 months to 17years with the diagnosis of Autism Spectrum Disorder. Participants will be recruited through posters and flyers in the Pediatric Emergency Room Waiting area; families who are interested in enrolling will enter the research study. Interested caregivers will be asked to complete a confidential survey that will identify areas that can be accommodated during their visit. This survey will then be automatically be printed for the ED staff and ambassador to review. The student will meet the family in the ED and accompany the family through their visit; the student will print the child's Accommodation Plan, place it at the bedside, and make it available for each member of the treatment team.
Students will be trained to chart a child's Accommodation Plan for each member of the treatment team and place it at bedside, as well to advocate on behalf of the child and their family, communicate with the staff (including nurses, primary care providers (physicians and Physician Assistants (PAs)), and techs (radiology, phlebotomy, transport). To the extent possible, the investigators hope that having a student advocate, educate staff in the ED, and implement changes as needed will improve patient satisfaction with the experience and improve the ease with which a procedure can be carried out for a child with ASD. Students will also be queried as to the experience and survey data will be used to improve the program over time.
Training will be completed so that all members of the treatment team will be aware of the program and aware of the possible accommodations. Treatment team members will be provided additional training to enhance the success of the ASAP program and all treatment team members will be encouraged to work together for the best possible outcome for all patients. Treatment team services include: nursing, ED physicians, PAs, technicians (radiology, phlebotomy, transport), registration, and to the extent possible, the personnel involved in the care of these children.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Assigned Ambassador
- Keywords
- Austism, Ambassador
- 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.
Assigned AmbassadorBehavioural
If assigned to the intervention group, participants will be assigned a medical student ambassador on arrival to the Emergency Department. A brief discussion may take place to review the child's history and survey results, and a copy of the survey will be placed near the patient's bedside for healthcare personnel to review. The student ambassador will accompany the child and their family through key points of their visit and will be expected to make accommodations for the child as determined by the accommodation survey results. The family will be required to allow the ambassador to stay throughout the ED visit.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Ambassador (Intervention Group) | Experimental | Patients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the ED visit will serve as our intervention group. The participants will be assigned an Ambassador throughout the child's ED visit and will complete a patient satisfaction survey afterwards. The investigators hold to enroll 120 controls. Receives: Behavioral: Assigned Ambassador |
| Control Group | No intervention | Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the ED visit will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the ED visit, however no ambassador will be assigned during the ED visit. The investigators hope to enroll 120 controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Survey (Questionnaire)
Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap. The questionnaire, likely titled "ASAP Patient Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.
Measured: 1 year.
Secondary outcomes (3)
Medical Student Satisfaction Survey (Questionnaire)
Overall medical student satisfaction with the ambassador program; data collected using REDCap.The questionnaire, likely titled "ASAP Medical Student Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.
Measured: 1 year
Medical Student Career Interest (Questionnaire)
Medical student career interests before and after participation in this program; data collected using REDCAP. The questionnaire, likely titled "Impact of ASAP on Career Interest" may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied but will also include unscaled questions with answers such as "very interested, somewhat interested, not interested, etc.".
Measured: 1 year
Medical Student Comfort Level (Questionnaire)
Medical student comfort level interacting with autistic children before and after participation in the program; data collected using REDCap.The questionnaire, likely titled "Impact of ASAP on Medical Student Comfort Levels with Patients with Autism", may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied among unscaled questions with answers such as "very comfortable, neutral, and very uncomfortable."
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Apr 2021 (estimated)
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Why it stopped: Terminated due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Tierney, Milton S. Hershey Medical Center
- Investigators
- Cheryl Tierney, M.D., Principal investigator, Developmental Pediatrics, Penn State Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186364
- Sponsor's protocol ID
- 00002020
- Status last verified
- Apr 2021
- First submitted
- 2 Dec 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gimbler Berglund I, Huus K, Enskar K, Faresjo M, Bjorkman B. Perioperative and Anesthesia Guidelines for Children with Autism: A Nationwide Survey from Sweden. J Dev Behav Pediatr. 2016 Jul-Aug;37(6):457-64. doi: 10.1097/DBP.0000000000000289.
PubMed 27011004Nayfack AM, Huffman LC, Feldman HM, Chan J, Saynina O, Wise PH. Hospitalizations of children with autism increased from 1999 to 2009. J Autism Dev Disord. 2014 May;44(5):1087-94. doi: 10.1007/s10803-013-1965-x.
PubMed 24122446Broder-Fingert S, Shui A, Ferrone C, Iannuzzi D, Cheng ER, Giauque A, Connors S, McDougle CJ, Donelan K, Neumeyer A, Kuhlthau K. A Pilot Study of Autism-Specific Care Plans During Hospital Admission. Pediatrics. 2016 Feb;137 Suppl 2:S196-204. doi: 10.1542/peds.2015-2851R.
PubMed 26908475
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of the Autism Spectrum Ambassador Program
- ClinicalTrials.gov ID
- NCT04186364
- Acronym / sponsor ID
- 00002020
- Conditions
- Autism Spectrum Disorder
- Keywords
- Austism, Ambassador
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are evaluating the implementation and the effectiveness of a medical student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder coming into Penn State Hershey Children's Hospital Emergency Department. The ASAP program involves training and assigning a medical student as an Ambassador to help advocate for the special needs of a child with ASD. This study is designed to compare patient satisfaction of children and families who are assigned an Ambassador to those who are not assigned an Ambassador during their time in the Emergency Department. The secondary objectives are to measure overall medical student satisfaction with the program, medical student career interests before and after participation, and medical student comfort level interacting with children with ASD before and after participation.
Detailed description
The Autism Spectrum Ambassador Program (ASAP) is a medical student staffed program designed to improve the experience for children with Autism Spectrum Disorder coming into the Children's Hospital Emergency Department (ED) for an acute visit. This program will pair an interested and trained medical student with a family whose child presents to the Children's Hospital ED and identifies as having Autism and requiring special accommodations to improve cooperation and procedure tolerance.
Patients will be identified by the study team members, who are ages 30 months to 17years with the diagnosis of Autism Spectrum Disorder. Participants will be recruited through posters and flyers in the Pediatric Emergency Room Waiting area; families who are interested in enrolling will enter the research study. Interested caregivers will be asked to complete a confidential survey that will identify areas that can be accommodated during their visit. This survey will then be automatically be printed for the ED staff and ambassador to review. The student will meet the family in the ED and accompany the family through their visit; the student will print the child's Accommodation Plan, place it at the bedside, and make it available for each member of the treatment team.
Students will be trained to chart a child's Accommodation Plan for each member of the treatment team and place it at bedside, as well to advocate on behalf of the child and their family, communicate with the staff (including nurses, primary care providers (physicians and Physician Assistants (PAs)), and techs (radiology, phlebotomy, transport). To the extent possible, the investigators hope that having a student advocate, educate staff in the ED, and implement changes as needed will improve patient satisfaction with the experience and improve the ease with which a procedure can be carried out for a child with ASD. Students will also be queried as to the experience and survey data will be used to improve the program over time.
Training will be completed so that all members of the treatment team will be aware of the program and aware of the possible accommodations. Treatment team members will be provided additional training to enhance the success of the ASAP program and all treatment team members will be encouraged to work together for the best possible outcome for all patients. Treatment team services include: nursing, ED physicians, PAs, technicians (radiology, phlebotomy, transport), registration, and to the extent possible, the personnel involved in the care of these children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned Ambassador (Intervention Group) | Experimental | Behavioral: Assigned AmbassadorPatients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the ED visit will serve as our intervention group. The participants will be assigned an Ambassador throughout the child's ED visit and will complete a patient satisfaction survey afterwards. The investigators hold to enroll 120 controls. |
| Control Group | No intervention | –Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the ED visit will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the ED visit, however no ambassador will be assigned during the ED visit. The investigators hope to enroll 120 controls. |
Who may qualify
- Ages
- 30 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Must be children 30 months to 17 years of age.
- Study participants will be boys and girls.
- Study participants will have a a diagnosis of Autism Spectrum Disorder.
- Study participants will be presenting through the pediatric emergency room at the Penn State Hershey Medical Center.
- Study participants must be English Speaking.
Key exclusion criteria (8 listed)
- Children under 30 months or older than 17 years.
- Children who do not have a diagnosis of Autism Spectrum Disorder.
- Children who cannot understand and communicate in English.
- Individuals who are not a medical student at the Penn State College of Medicine.
- Medical students who do not complete the training course.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned AmbassadorIf assigned to the intervention group, participants will be assigned a medical student ambassador on arrival to the Emergency Department. A brief discussion may take place to review the child's history and survey results, and a copy of the survey will be placed near the patient's bedside for healthcare personnel to review. The student ambassador will accompany the child and their family through key points of their visit and will be expected to make accommodations for the child as determined by the accommodation survey results. The family will be required to allow the ambassador to stay throughout the ED visit. | Behavioural | Assigned Ambassador (Intervention Group) |
Primary outcome
Patient Satisfaction Survey (Questionnaire)
Time frame: 1 year.
Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap. The questionnaire, likely titled "ASAP Patient Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.
3 secondary outcomes
Medical Student Satisfaction Survey (Questionnaire)
Time frame: 1 year
Medical Student Career Interest (Questionnaire)
Time frame: 1 year
Medical Student Comfort Level (Questionnaire)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 27011004Gimbler Berglund I, Huus K, Enskar K, Faresjo M, Bjorkman B. Perioperative and Anesthesia Guidelines for Children with Autism: A Nationwide Survey from Sweden. J Dev Behav Pediatr. 2016 Jul-Aug;37(6):457-64. doi: 10.1097/DBP.0000000000000289.
- Background: PubMed 24122446Nayfack AM, Huffman LC, Feldman HM, Chan J, Saynina O, Wise PH. Hospitalizations of children with autism increased from 1999 to 2009. J Autism Dev Disord. 2014 May;44(5):1087-94. doi: 10.1007/s10803-013-1965-x.
- Background: PubMed 26908475Broder-Fingert S, Shui A, Ferrone C, Iannuzzi D, Cheng ER, Giauque A, Connors S, McDougle CJ, Donelan K, Neumeyer A, Kuhlthau K. A Pilot Study of Autism-Specific Care Plans During Hospital Admission. Pediatrics. 2016 Feb;137 Suppl 2:S196-204. doi: 10.1542/peds.2015-2851R.
- Study ProtocolLink provided by the sponsor.
- Informed Consent FormLink provided by the sponsor.
- Accommodation SurveyLink provided by the sponsor.
- Patient Satisfaction SurveyLink provided by the sponsor.
- Medical Student SurveyLink provided by the sponsor.
- Summary Explanation of Research - for Medical StudentsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Tierney, M.D. principal investigator
Developmental Pediatrics, Penn State Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Ambassador 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient Satisfaction Survey (Questionnaire) (time frame: 1 year.). 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 NCT04186364, which also lists 3 linked publications.
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 Apr 2021; AzTrials last refreshed its copy on 29 Oct 2026.