Autism Spectrum DisorderNCT03232775
Use of a Visual Pedagogy and Structure With Children With Autism for Routine Physical Exams
A study testing Treatment: Physical Exam with Visual Pedagogy and Structure in people with Autism Spectrum Disorder, run by University of Colorado, Denver.
Trial summary
Children with autism spectrum disorders (ASDs) have unique social-communication and behavior impairments that complicate their medical management. This study aimed to evaluate the effectiveness of using a picture schedule paired with a reinforcement system during the medical exam. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Treatment: Physical Exam with Visual Pedagogy and Structure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronological ages 4 to 10 years.
- Presumptive diagnosis of Autistic Disorder or Asperger's Disorder prior to study admission from a psychologist or psychiatrist experienced with children who have autism.
- Meets research criteria for Autistic Spectrum Disorder:
- Meets cut-off scores for autism spectrum on the Social Communication Questionnaire (SCQ) (cut-off = 15) and
- Meets empirically-derived algorithm cut-off scores for Autism Spectrum Disorders on the Autism Diagnostic Observation Schedule (ADOS).
- All subjects will have the ADOS administered by a clinician trained in research reliability standards.
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- The Principal Investigator, a certified ADOS trainer and research reliable, or trained designee under the supervision of the Principal Investigator, will administer the ADOS.
- Participants will represent the typical DSM-IV diagnostic developmental profile of children on the autism spectrum and no neurological injuries or illnesses before the age of three years that could account for their symptoms (i.e., meningitis, encephalitis, severe head injury or seizure disorder).
- A Communication standard score ≤ 85, as measured by the Vineland Adaptive Behavior Scales - II.
- The VABS-II will be administered by the Principal Investigator or trained designee under the supervision of the Principal Investigator as part of the initial phone screening process.
- Children with an ASD, particularly school-aged children and adolescents, may present with myriad prescribed psychotropic medications. Therefore, we will not exclude children on a variety of psychotropic medications; rather we will conduct a qualitative analysis to look at this issue.
- No restrictions regarding race or gender will be applied to the autism or developmental disability sample. Every effort will be made not to over-represent any particular race and/or gender group.
- Physically healthy prior to physical exam.
- Previous exposure to visual systems. This will be assessed based on caregiver report during the phone screening using one question relating to the use of visual structure with the child.
- History of:
- Poor Cooperation
- Completely Uncooperative
- Physical exams rated by caregiver on 4-point scale of cooperation modified from Forsberg et al. [56].
- 0 = No problems with cooperation;
- 1 = Minor problems with cooperation: Child shows mild behavior problems and/or anxiety symptoms;
- 2 = Poor cooperation: Child's behavior problems and/or anxiety symptoms requires that the medical staff have to spend extra time and effort to manage the child and complete the exam;
- 3 = Completely uncooperative: Exam is not possible due to child's behavior problems and/or anxiety symptoms
Who cannot join
- Participants with intelligence quotient standard scores > 40.
- Presence of the following genetic or progressive neurological disorders known to be causative of or potentially resulting in a phenotype similar to autism:
- Fragile X,
- Landau Kleffner, Rett Disorder,
- Childhood Disintegrative Disorder, or
- Tuberous Sclerosis, based on screening by clinical staff and subsequent review by medical staff as needed
- Presence of vision or hearing loss or significant motor impairments.
- Wards of the State.
About this study
Official title: Evaluating the Effects of a Visual Pedagogy and Structure on the Successful Completion of the Medical Office Visit and Physical Examination With Pre-pubescent Children With Autism
Children with autism spectrum disorders (ASDs) have unique social-communication and behavior impairments that complicate their medical management. This study aimed to evaluate the effectiveness of using a picture schedule paired with a reinforcement system during the medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with ASD and below average adaptive communication impairment were asked to participate. Following participation in an overview of autism diagnostic symptoms training, two teams (comprised of one chief medical resident and one nurse), blind to the study aim, conducted the study exams.
Read the detailed description
Objective: This pilot study aimed to evaluate the effects of a picture-schedule reinforcement system on reducing problem behaviors in children with Autism Spectrum Disorder (ASD) during a physical exam.
Design, setting, patients, intervention: Fifteen study participants, aged 5-10 years, with autism and identified by caregivers as typically uncooperative with physical exams were randomized to one of two physical exam groups (treatment and control) based on their adaptive communication score. The treatment group exam included use of a picture schedule-reinforcement book and the control group exam did not introduce the book. Caregivers rated participants' irritability/stereotypy behaviors before and during study exams. Exam teams blinded to study aims, recorded participants' total exam items completed and caregivers rated participants' level of cooperation.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Treatment: Physical Exam with Visual Pedagogy and Structure, Control: Physical Exam without Visual Pedagogy and Structure
- Keywords
- visual pedagogy
- 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.
Treatment: Physical Exam with Visual Pedagogy and StructureOther
Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).
Control: Physical Exam without Visual Pedagogy and StructureOther
Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Treatment: Physical Exam with Visual Pedagogy and Structure Receives: Other: Treatment: Physical Exam with Visual Pedagogy and Structure |
| Control | Other | Control: Physical Exam without Visual Pedagogy and Structure Receives: Other: Control: Physical Exam without Visual Pedagogy and Structure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)
Caregiver report form of subjects' behaviors.
Measured: The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam
Secondary outcomes (2)
Number of study exam items completed during study exams
Study medical personnel teams (nurse and medical resident) tallied number of total exam items completed during study exams with each participant
Measured: Within 15 minutes after conclusion of each participant's study exam.
Change from baseline in Cooperation likert-scale rating form
Caregiver report form of subjects' cooperation behaviors during study physical exams.
Measured: At study entry and within 15 minutes after the completion of study physical exams
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Robin Gabriels, PsyD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232775
- Sponsor's protocol ID
- 07-0362
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of a Visual Pedagogy and Structure on the Successful Completion of the Medical Office Visit and Physical Examination With Pre-pubescent Children With Autism
- ClinicalTrials.gov ID
- NCT03232775
- Acronym / sponsor ID
- 07-0362
- Conditions
- Autism Spectrum Disorder
- Keywords
- visual pedagogy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- Sep 2007 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with autism spectrum disorders (ASDs) have unique social-communication and behavior impairments that complicate their medical management. This study aimed to evaluate the effectiveness of using a picture schedule paired with a reinforcement system during the medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with ASD and below average adaptive communication impairment were asked to participate. Following participation in an overview of autism diagnostic symptoms training, two teams (comprised of one chief medical resident and one nurse), blind to the study aim, conducted the study exams.
Detailed description
Objective: This pilot study aimed to evaluate the effects of a picture-schedule reinforcement system on reducing problem behaviors in children with Autism Spectrum Disorder (ASD) during a physical exam.
Design, setting, patients, intervention: Fifteen study participants, aged 5-10 years, with autism and identified by caregivers as typically uncooperative with physical exams were randomized to one of two physical exam groups (treatment and control) based on their adaptive communication score. The treatment group exam included use of a picture schedule-reinforcement book and the control group exam did not introduce the book. Caregivers rated participants' irritability/stereotypy behaviors before and during study exams. Exam teams blinded to study aims, recorded participants' total exam items completed and caregivers rated participants' level of cooperation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Other: Treatment: Physical Exam with Visual Pedagogy and StructureTreatment: Physical Exam with Visual Pedagogy and Structure |
| Control | Other | Other: Control: Physical Exam without Visual Pedagogy and StructureControl: Physical Exam without Visual Pedagogy and Structure |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (22 listed)
- Chronological ages 4 to 10 years.
- Presumptive diagnosis of Autistic Disorder or Asperger's Disorder prior to study admission from a psychologist or psychiatrist experienced with children who have autism.
- Meets research criteria for Autistic Spectrum Disorder:
- Participants will represent the typical DSM-IV diagnostic developmental profile of children on the autism spectrum and no neurological injuries or illnesses before the age of three years that could account for their symptoms (i.e., meningitis, encephalitis, severe head injury or seizure disorder).
- A Communication standard score ≤ 85, as measured by the Vineland Adaptive Behavior Scales - II.
Key exclusion criteria (8 listed)
- Participants with intelligence quotient standard scores > 40.
- Presence of the following genetic or progressive neurological disorders known to be causative of or potentially resulting in a phenotype similar to autism:
- Presence of vision or hearing loss or significant motor impairments.
- Wards of the State.
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 |
|---|---|---|
| Treatment: Physical Exam with Visual Pedagogy and StructureRoutine physical examination participants receive visual pedagogy and reinforcement (preferred food treat). | Other | Treatment |
| Control: Physical Exam without Visual Pedagogy and StructureParticipants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat). | Other | Control |
Primary outcome
Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)
Time frame: The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam
Caregiver report form of subjects' behaviors.
2 secondary outcomes
Number of study exam items completed during study exams
Time frame: Within 15 minutes after conclusion of each participant's study exam.
Change from baseline in Cooperation likert-scale rating form
Time frame: At study entry and within 15 minutes after the completion of study physical exams
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- 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.
Robin Gabriels, PsyD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Treatment: Physical Exam with Visual Pedagogy and Structure in people with Autism Spectrum Disorder, run by University of Colorado, Denver.
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 22 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales) (time frame: The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2017.