NCT02842671

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

July 13, 2016

Last Update Submit

June 16, 2021

Conditions

Autism Spectrum Disorder

Keywords

autismambassador

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction Survey (questionnaire)

    Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap

    1 year

Secondary Outcomes (3)

  • Medical Student Satisfaction Survey (questionnaire)

    1 year

  • Medical Student Career Interest (questionnaire)

    1 year

  • Medical Student Comfort Level (questionnaire)

    1 year

Study Arms (2)

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.

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.

Interventions

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.

Assigned Ambassador (Intervention Group)

Eligibility Criteria

Age30 Months - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. 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

You may not qualify if:

  • 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
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (3)

  • 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.

    PMID: 27011004BACKGROUND

  • 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. doi: 10.1007/s10803-013-1965-x.

    PMID: 24122446BACKGROUND

  • 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.

    PMID: 26908475BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Cheryl Tierney, M.D.

    Developmental Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief, Behavior and Developmental Pediatrics

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 25, 2016

Study Start

December 1, 2016

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

US(1)