Autism Spectrum DisorderASDNCT02675933
Satisfaction Rates Among Parents of Children With Autism in the ED
A study testing Questionnaire in people with Autism Spectrum Disorder, run by Seton Healthcare Family at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 6 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- triage level 1
- physician provider unable to review questionnaire prior to seeing the patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
About this study
Official title: What Factors Effect Parental Satisfaction During Their Visit to a Pediatric Emergency Department Among Parents of Children With Autism?
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.
Read the detailed description
This study is a randomized controlled trial utilizing a patient-centered questionnaire distributed to parents of children with autism. Potential study participants will be identified during the triage process through medical history taking, which is routine for the triage process at this institution. The triage nurse will be educated to alert a research associate if a patient with one of our qualifying diagnoses is identified. This study will include patients aged 2-18 with parental report of a diagnosis of (1) Autism, (2) Autism Spectrum Disorder, (3) Pervasive Developmental Disorder, (4) Childhood Disintegrative Disorder, or (5) Sensory Integration Disorder. All patients whose caregiver is fluent and literate in either English or Spanish will be included.
Research associates will then attempt to obtain consent from the parent. If consent is obtained, the research associate will then attempt to obtain assent from patients aged > 6 years. If the research associate feels the child is unable to assent based on their developmental capabilities, the research associate will then indicate this on the assent form and sign in the space provided for the research associate.
Once consent and assent, if applicable, are obtained, the research associate will then select an envelope from the top of a pre-randomized stack. The contents of the envelope will either contain a questionnaire and satisfaction survey for the intervention arm, or simply a satisfaction survey if in the control arm.
If the intervention arm is selected, the research associate will then distribute the questionnaire to the parent and ask them to fill it out to the best of their ability. The research associate will then return to collect the questionnaire and one of the physician providers caring for the patient must review the questionnaire prior to seeing the patient. This hospital is a teaching institution and physician providers may include residents, fellows, and attendings.
Once reviewed, the physician provider will sign at the bottom of the questionnaire and proceed with the encounter. Multiple providers, including nursing staff and clinical assistants may review the questionnaire as well, which will be kept on the paper chart.
When the patient's disposition is determined, the research associate will distribute the satisfaction survey and an envelope for the survey to be sealed within once completed by the parent. The satisfaction survey, along with the questionnaire and any other study documents, will be collected and placed in the envelope. The envelopes will be stored in a badge-access protected office inside of a locked cabinet behind a password protected door. Only fellows, attendings, and a few fellowship-associated and research-associated providers have access to this office.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Questionnaire
- 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.
QuestionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction Scores
Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.
Measured: through study completion, 1 day (clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion6 Jan 2017
- Study completion6 Jan 2017
Why it stopped: Seton IRB administratively closed this study on January 6, 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine E Yee, MD, Principal investigator, Pediatric Emergency Medicine Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675933
- Sponsor's protocol ID
- CR-15-162
- Acronym
- ASD
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2016
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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/
PubMed 25057539Jo 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.
PubMed 25701197Autism 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.
PubMed 22456193
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Factors Effect Parental Satisfaction During Their Visit to a Pediatric Emergency Department Among Parents of Children With Autism?
- ClinicalTrials.gov ID
- NCT02675933
- Acronym / sponsor ID
- ASD / CR-15-162
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Seton IRB administratively closed this study on January 6, 2017
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized controlled trial utilizing a patient-centered questionnaire distributed to parents of children with autism. Potential study participants will be identified during the triage process through medical history taking, which is routine for the triage process at this institution. The triage nurse will be educated to alert a research associate if a patient with one of our qualifying diagnoses is identified. This study will include patients aged 2-18 with parental report of a diagnosis of (1) Autism, (2) Autism Spectrum Disorder, (3) Pervasive Developmental Disorder, (4) Childhood Disintegrative Disorder, or (5) Sensory Integration Disorder. All patients whose caregiver is fluent and literate in either English or Spanish will be included.
Research associates will then attempt to obtain consent from the parent. If consent is obtained, the research associate will then attempt to obtain assent from patients aged > 6 years. If the research associate feels the child is unable to assent based on their developmental capabilities, the research associate will then indicate this on the assent form and sign in the space provided for the research associate.
Once consent and assent, if applicable, are obtained, the research associate will then select an envelope from the top of a pre-randomized stack. The contents of the envelope will either contain a questionnaire and satisfaction survey for the intervention arm, or simply a satisfaction survey if in the control arm.
If the intervention arm is selected, the research associate will then distribute the questionnaire to the parent and ask them to fill it out to the best of their ability. The research associate will then return to collect the questionnaire and one of the physician providers caring for the patient must review the questionnaire prior to seeing the patient. This hospital is a teaching institution and physician providers may include residents, fellows, and attendings.
Once reviewed, the physician provider will sign at the bottom of the questionnaire and proceed with the encounter. Multiple providers, including nursing staff and clinical assistants may review the questionnaire as well, which will be kept on the paper chart.
When the patient's disposition is determined, the research associate will distribute the satisfaction survey and an envelope for the survey to be sealed within once completed by the parent. The satisfaction survey, along with the questionnaire and any other study documents, will be collected and placed in the envelope. The envelopes will be stored in a badge-access protected office inside of a locked cabinet behind a password protected door. Only fellows, attendings, and a few fellowship-associated and research-associated providers have access to this office.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: QuestionnaireParticipants 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- triage level 1
- physician provider unable to review questionnaire prior to seeing the patient
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 |
|---|---|---|
| QuestionnaireThere will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm. | Behavioural | Questionnaire |
Primary outcome
Satisfaction Scores
Time frame: through study completion, 1 day (clinic visit)
Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25057539Institute 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/
- Background: PubMed 25701197Jo 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.
- Background: PubMed 22456193Autism 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.
- Individual participant dataSharing planned: No
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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.
Catherine E Yee, MD principal investigator
Pediatric Emergency Medicine Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Autism Spectrum Disorder, run by Seton Healthcare Family 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 2 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: stopped early, as of the sponsor's last update on 9 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Satisfaction Scores (time frame: through study completion, 1 day (clinic visit)). 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 NCT02675933, 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 9 Dec 2024.