Autism Spectrum DisorderPEARSNCT05153551
Pediatric Early Autism Recognition System: PEARS
A study testing Play-based assessment (RITA-T) in people with Autism Spectrum Disorder, run by University of Michigan at 3 sites in United States.
Trial summary
The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician. The study hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Play-based assessment (RITA-T)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2022to 18 Oct 2022
- 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 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Increased risk for Autism Spectrum Disorder (ASD) defined as:
- positive Modified Checklist for Autism in Toddlers-Revised (MCHAT) (score greater than 3);
- OR having a sibling or parent with ASD;
- OR history of prematurity (gestational age less or equal 34 weeks);
- OR other provider or parent concern for ASD.
- Child age 18-36 months
- Parent or legal guardian of the children
Who cannot join
- previous ASD diagnosis
- previous negative ASD evaluation
- known seizure disorder
- vision impairment
- hearing impairment
- Not a Parent or legal guardian of the child
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michigan Medicine Briarwood Center for Women, Children, and Young Adults.
Ann Arbor, Michigan, 48108
Michigan Medicine Brighton Health Center
Brighton, Michigan, 48116
Michigan Medicine Northville Health Center
Northville, Michigan, 48168
About this study
The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician.
The study hypotheses:
- The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.
- The PEARS intervention will lead to increased parent activation around autism diagnosis.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Play-based assessment (RITA-T)
- Keywords
- Early diagnosis
- Medical subject headings
- Autism Spectrum Disorder, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play-based assessment (RITA-T)Other
The RITA-T is a play-based assessment that involves nine different activities that can be done safely with a child seated in the exam room. After scoring the RITA-T, the PEARS PCP will immediately provide feedback to the parent regarding results and next steps.
In addition, parents will complete certain assessments/surveys during the study to evaluate the program.
| Study group | Role | What they receive |
|---|---|---|
| PEARS assessment | Experimental | Not described Receives: Other: Play-based assessment (RITA-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).
Measured: Approximately day 7 (Time 3)
Percentage of parents that felt that the RITA-T visit was comfortable and useful
This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).
Measured: Approximately day 35 (time 5)
Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)
Items are scored using a 4-point a Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0 to 100 using weighted scores based on Guttman scaling. Higher scores correspond to higher activation. This 13-item measure will be administered verbally to parents at baseline and 3-4 weeks post-RITA-T assessment. Changes from baseline to follow-up will be calculated for each participant.
Measured: Baseline(day 1), approximately day 35 (time 5)
Qualitative data from parents semi-structured interviews
The study team will analyze transcripts of parent semi-structured interviews to assess general sense of empowerment and motivation, with a focus on novel insights into the experience of parents of children undergoing a Level-2 screening instrument within the medical home.
Measured: Approximately day 35 (time 5)
Secondary outcomes (2)
The number of days between enrollment and completed RITA-T assessment
Measured: Approximately 7-14 days
The percentage of participants that experienced scheduling and/or transportation barriers
This data will be collected by the research assistants or reported by parents during the follow-up semi-structured interview.
Measured: Approximately day 35 (time 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start27 Jan 2022
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
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 MichiganThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 30 families (30 children and 30 parents/legal guardians) to be enrolled
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Nicole Hamp, University of Michigan
- Investigators
- Nicole Hamp, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153551
- Sponsor's protocol ID
- HUM00203538
- Acronym
- PEARS
- Status last verified
- Oct 2022
- First submitted
- 29 Nov 2021
- Last updated
- 20 Oct 2022
- 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 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Early Autism Recognition System: PEARS
- ClinicalTrials.gov ID
- NCT05153551
- Acronym / sponsor ID
- PEARS / HUM00203538
- Conditions
- Autism Spectrum Disorder
- Keywords
- Early diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 10 Dec 2021 (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.
The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician.
The study hypotheses:
- The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.
- The PEARS intervention will lead to increased parent activation around autism diagnosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30 families (30 children and 30 parents/legal guardians) to be enrolled
| Arm | Type | Receives |
|---|---|---|
| PEARS assessment | Experimental | Other: Play-based assessment (RITA-T) |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Increased risk for Autism Spectrum Disorder (ASD) defined as:
- Child age 18-36 months
- Parent or legal guardian of the children
Key exclusion criteria (6 listed)
- previous ASD diagnosis
- previous negative ASD evaluation
- known seizure disorder
- vision impairment
- hearing impairment
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 |
|---|---|---|
| Play-based assessment (RITA-T)The RITA-T is a play-based assessment that involves nine different activities that can be done safely with a child seated in the exam room. After scoring the RITA-T, the PEARS PCP will immediately provide feedback to the parent regarding results and next steps. In addition, parents will complete certain assessments/surveys during the study to evaluate the program. | Other | PEARS assessment |
Primary outcome
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T
Time frame: Approximately day 7 (Time 3)
This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).
Percentage of parents that felt that the RITA-T visit was comfortable and useful
Time frame: Approximately day 35 (time 5)
This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).
Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)
Time frame: Baseline(day 1), approximately day 35 (time 5)
Items are scored using a 4-point a Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0 to 100 using weighted scores based on Guttman scaling. Higher scores correspond to higher activation. This 13-item measure will be administered verbally to parents at baseline and 3-4 weeks post-RITA-T assessment. Changes from baseline to follow-up will be calculated for each participant.
Qualitative data from parents semi-structured interviews
Time frame: Approximately day 35 (time 5)
The study team will analyze transcripts of parent semi-structured interviews to assess general sense of empowerment and motivation, with a focus on novel insights into the experience of parents of children undergoing a Level-2 screening instrument within the medical home.
2 secondary outcomes
The number of days between enrollment and completed RITA-T assessment
Time frame: Approximately 7-14 days
The percentage of participants that experienced scheduling and/or transportation barriers
Time frame: Approximately day 35 (time 5)
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 20 Oct 2022.
- 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.
Nicole Hamp, MD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play-based assessment (RITA-T) in people with Autism Spectrum Disorder, run by University of Michigan at 3 sites 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 7 inclusion and 6 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T (time frame: Approximately day 7 (Time 3)). The study lists 4 primary outcomes in all. 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 20 Oct 2022.