Autism Spectrum Disorder
Conditions
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.
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.
Interventions
BEHAVIORALQuestionnaire
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.
Sponsors
Seton Healthcare Family
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* triage level 1 * physician provider unable to review questionnaire prior to seeing the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Scores | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care 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. | 32 |
| Questionnaire 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.
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. | 31 |
| Total | 63 |
Baseline characteristics
| Characteristic | Questionnaire | Total | Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 63 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.72 years | 8.52 years | 8.32 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 31 participants | 63 participants | 32 participants |
| Sex: Female, Male Female | 26 Participants | 50 Participants | 24 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Satisfaction Scores | 4.1 score on a scale |
| Questionnaire | Satisfaction Scores | 4.5 score on a scale |