Autism Spectrum DisorderASAPNCT02842671
Autism Spectrum Ambassador Program
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 for a medical procedure. Read more about this study
- Who is it for?
- Ages 30 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Assigned Ambassador
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 25 Nov 2019
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Study participants will be children 30 months to 17 years 2. Study participants will be boys and girls 3. Study participants will have a diagnosis of Autism Spectrum Disorder 4. Study participants will be presenting through the pediatric anesthesia clinic in preparation for a surgical or nonsurgical procedure at the Children's Hospital 5. Study participants must be English Speaking
- 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
- Children under 30 months or older than 17 years
- Children who do not have a diagnosis of Autism Spectrum Disorder
- Children who are not having surgery at the Children's Hospital
- Children who are having a procedure but are not being seen for a pre-anesthesia visit
- Children who cannot understand and communicate in English
- 1. Individuals who are not a medical student at the Penn State College of Medicine 2. Medical students who do not complete the training course 3. 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 Children's Hospital
Hershey, Pennsylvania, 17033
About this study
Official title: The 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 for a medical procedure. 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 the procedure. 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 for a day procedure involving anesthesia. This program will pair an interested and trained medical student with a family whose child is scheduled for an outpatient procedure and who is identified as possibly needing special accommodations to improve cooperation and procedure tolerance.
Patients will be identified using the Anesthesia clinic's schedule via PowerChart, consented at the pre-operative anesthesia clinic visit, and enrolled in our program by study personnel. Once enrolled, families will be asked to complete a confidential survey that will identify areas that can be accommodated on the procedure day. Students will gain access to these survey results, contact the family at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The student will then create a written, personalized Accommodation Plan to be distributed to personnel and the family. The student will meet the family at the hospital and accompany the family check in until the patient is in the post anesthesia recovery unit.
Students will be trained to chart a child's Accommodation Plan for each member of the treatment team which will be distributed by the student with ample time before the procedure. This accommodation plan will alert each treatment team member including surgical nursing, anesthesia, registration, and to the extent possible surgeons, to what accommodations will be needed to improve the experience of the child. Students will be trained to assist with accommodations by communicating on the family's behalf to hospital personnel to include surgical nursing, anesthesia, registration, and to the extent possible surgeons, among others.
To the extent possible, the investigators hope that having a student advocate, educate staff on the procedure day, 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: surgical nursing, anesthesia, registration, and to the extent possible the surgeons involved in the care of these children.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Assigned Ambassador
- Keywords
- autism, ambassador
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned AmbassadorOther
If assigned to the intervention group, participants will be contacted by the assigned medical student ambassador at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The family will be met by the Ambassador at the hospital and stay with the family until the patient is in the post anesthesia recovery unit. The ambassador is expected to make accommodations for the child as determined by the accommodations survey results. The family will be required to allow the Ambassador to stay through check-in and the procedure.
| 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 the procedure will serve as our intervention group. The participants will be assigned an Ambassador throughout the procedure and will complete a patient satisfaction survey afterwards. The investigators hope to enroll 25 controls. Receives: Other: 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 patient's procedure will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the procedure. No ambassador will be assigned for the procedure day. The investigators hope to enroll 25 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
Measured: 1 year
Secondary outcomes (3)
Medical Student Satisfaction Survey (questionnaire)
Overall medical student satisfaction with the ambassador program; data collected using REDCap
Measured: 1 year
Medical Student Career Interest (questionnaire)
Medical student career interests before and after participation in this program; data collected using REDCap
Measured: 1 year
Medical Student Comfort Level (questionnaire)
Medical student comfort level interacting with autistic children before and after participation in this program; data collected using REDCap
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 posted25 Jul 2016 (estimated)
- Study start1 Dec 2016
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
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
- 23 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842671
- Sponsor's protocol ID
- 00004103
- Acronym
- ASAP
- Status last verified
- Jun 2021
- First submitted
- 13 Jul 2016
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation and Evaluation of the Autism Spectrum Ambassador Program
- ClinicalTrials.gov ID
- NCT02842671
- Acronym / sponsor ID
- ASAP / 00004103
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, ambassador
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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 for a medical procedure. 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 the procedure. 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 for a day procedure involving anesthesia. This program will pair an interested and trained medical student with a family whose child is scheduled for an outpatient procedure and who is identified as possibly needing special accommodations to improve cooperation and procedure tolerance.
Patients will be identified using the Anesthesia clinic's schedule via PowerChart, consented at the pre-operative anesthesia clinic visit, and enrolled in our program by study personnel. Once enrolled, families will be asked to complete a confidential survey that will identify areas that can be accommodated on the procedure day. Students will gain access to these survey results, contact the family at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The student will then create a written, personalized Accommodation Plan to be distributed to personnel and the family. The student will meet the family at the hospital and accompany the family check in until the patient is in the post anesthesia recovery unit.
Students will be trained to chart a child's Accommodation Plan for each member of the treatment team which will be distributed by the student with ample time before the procedure. This accommodation plan will alert each treatment team member including surgical nursing, anesthesia, registration, and to the extent possible surgeons, to what accommodations will be needed to improve the experience of the child. Students will be trained to assist with accommodations by communicating on the family's behalf to hospital personnel to include surgical nursing, anesthesia, registration, and to the extent possible surgeons, among others.
To the extent possible, the investigators hope that having a student advocate, educate staff on the procedure day, 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: surgical nursing, anesthesia, registration, and to the extent possible the surgeons 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 | Other: Assigned AmbassadorPatients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the the procedure will serve as our intervention group. The participants will be assigned an Ambassador throughout the procedure and will complete a patient satisfaction survey afterwards. The investigators hope to enroll 25 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 patient's procedure will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the procedure. No ambassador will be assigned for the procedure day. The investigators hope to enroll 25 controls. |
Who may qualify
- Ages
- 30 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1. Study participants will be children 30 months to 17 years 2. Study participants will be boys and girls 3. Study participants will have a diagnosis of Autism Spectrum Disorder 4. Study participants will be presenting through the pediatric anesthesia clinic in preparation for a surgical or nonsurgical procedure at the Children's Hospital 5. Study participants must be English Speaking
- 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
Key exclusion criteria (6 listed)
- Children under 30 months or older than 17 years
- Children who do not have a diagnosis of Autism Spectrum Disorder
- Children who are not having surgery at the Children's Hospital
- Children who are having a procedure but are not being seen for a pre-anesthesia visit
- Children who cannot understand and communicate in English
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 contacted by the assigned medical student ambassador at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The family will be met by the Ambassador at the hospital and stay with the family until the patient is in the post anesthesia recovery unit. The ambassador is expected to make accommodations for the child as determined by the accommodations survey results. The family will be required to allow the Ambassador to stay through check-in and the procedure. | Other | 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
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
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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
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 3 inclusion and 6 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 18 Jun 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 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?
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 NCT02842671, 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 18 Jun 2021; AzTrials last refreshed its copy on 29 Oct 2026.