Satisfaction Rates Among Parents of Children With Autism in the ED

NCT02675933 | Terminated Results DMC

• 1 other identifier: CR-15-162
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial utilizing a patient-centered questionnaire distributed to parents of children with autism. The study arm will receive the questionnaire and will be compared to the control arm, which will receive standard of care. The results of satisfaction surveys will be the primary endpoint of this study.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Satisfaction Scores

  Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.

  through study completion, 1 day (clinic visit)

Study Arms (2)

Standard of Care

NO INTERVENTION

The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials. All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients.

Questionnaire

ACTIVE COMPARATOR

Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient. Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.

Questionnaire

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 2 to 18 years
• parent/caregiver is fluent and literate in either English or Spanish
• parental report of a diagnosis of (1) autism, (2) autism spectrum disorder, (3) pervasive developmental disorder, (4) childhood disintegrative disorder, (5) sensory integration disorder

You may not qualify if:

• triage level 1
• physician provider unable to review questionnaire prior to seeing the patient

Sponsors & Collaborators

• Seton Healthcare Family: lead

Study Sites (1)

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Related Publications (3)

• Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/

  PMID: 25057539 BACKGROUND

• Jo H, Schieve LA, Rice CE, Yeargin-Allsopp M, Tian LH, Blumberg SJ, Kogan MD, Boyle CA. Age at Autism Spectrum Disorder (ASD) Diagnosis by Race, Ethnicity, and Primary Household Language Among Children with Special Health Care Needs, United States, 2009-2010. Matern Child Health J. 2015 Aug;19(8):1687-97. doi: 10.1007/s10995-015-1683-4.

  PMID: 25701197 BACKGROUND

• Autism and Developmental Disabilities Monitoring Network Surveillance Year 2008 Principal Investigators; Centers for Disease Control and Prevention. Prevalence of autism spectrum disorders--Autism and Developmental Disabilities Monitoring Network, 14 sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30;61(3):1-19.

  PMID: 22456193 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

No final reported analysis. Study terminated.

Results Point of Contact

• Title: Dr. Catherine Yee
• Organization: Dell Children's Medical Center of Central Texas

ceyee@ascension.org

5123240000

Study Officials

• Catherine E Yee, MD

  Pediatric Emergency Medicine Fellow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 5, 2016
• Study Start: February 1, 2016
• Primary Completion: January 6, 2017
• Study Completion: January 6, 2017
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)