Autism Spectrum Disorder Clinical Trial
— ASAPOfficial title:
The Implementation and Evaluation of the Autism Spectrum Ambassador Program
| Verified date | June 2021 |
| Source | Milton S. Hershey Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | November 25, 2019 |
| Est. primary completion date | November 25, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Months to 17 Years |
| Eligibility | Inclusion Criteria: 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 1. Ambassadors must be enrolled as first, second, third, or fourth year medical students at the Penn State College of Medicine 2. Ambassadors must complete training successfully Exclusion Criteria: 1. Children under 30 months or older than 17 years 2. Children who do not have a diagnosis of Autism Spectrum Disorder 3. Children who are not having surgery at the Children's Hospital 4. Children who are having a procedure but are not being seen for a pre-anesthesia visit 5. 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Penn State Hershey Children's Hospital | Hershey | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Milton S. Hershey Medical Center |
United States,
Broder-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. — View Citation
Gimbler Berglund I, Huus K, Enskär K, Faresjö M, Björkman 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. — View Citation
Nayfack 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient Satisfaction Survey (questionnaire) | Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap | 1 year | |
| Secondary | Medical Student Satisfaction Survey (questionnaire) | Overall medical student satisfaction with the ambassador program; data collected using REDCap | 1 year | |
| Secondary | Medical Student Career Interest (questionnaire) | Medical student career interests before and after participation in this program; data collected using REDCap | 1 year | |
| Secondary | Medical Student Comfort Level (questionnaire) | Medical student comfort level interacting with autistic children before and after participation in this program; data collected using REDCap | 1 year |
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