An interventional study of Questionnaire in Autism Spectrum Disorder, sponsored by Seton Healthcare Family. Terminated at 1 site in United States. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Seton Healthcare Family · Not applicable, Interventional, and Supportive care
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 63 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Seton Healthcare Family is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Satisfaction Scores
Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.
Time frame: through study completion, 1 day (clinic visit)
| Milestone | Standard of Care | Questionnaire |
|---|---|---|
| Started | 32 | 31 |
| Completed | 32 | 31 |
| Not completed | 0 | 0 |
Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.
| score on a scale | Standard of Care | Questionnaire |
|---|---|---|
| Satisfaction Scores | 4.1 (1 to 5) | 4.5 (1 to 5) |
Collected over through study completion, 1 day (clinic visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Questionnaire | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Event | Standard of Care | Questionnaire |
|---|---|---|
| Data breachInvestigations | 0/32 | 0/31 |
| Age, Categorical(Participants) | Standard of Care | Questionnaire | Total |
|---|---|---|---|
| <=18 years | 32 | 31 | 63 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Standard of Care | Questionnaire | Total |
|---|---|---|---|
| Mean | 8.32 (2 to 15) | 8.72 (2 to 17) | 8.52 (2 to 17) |
| Sex: Female, Male(Participants) | Standard of Care | Questionnaire | Total |
|---|---|---|---|
| Female | 24 | 26 | 50 |
| Male | 8 | 5 | 13 |
| Race and Ethnicity Not Collected(Participants) | Standard of Care | Questionnaire | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Standard of Care | Questionnaire | Total |
|---|---|---|---|
| United States | 32 | 31 | 63 |
Plan to share: No
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seton Healthcare Family