Autism Spectrum DisorderNCT04467073
Stepped-care Telehealth for Young Children With ASD
A study testing Online RIT in people with Autism Spectrum Disorder, run by Rush University Medical Center at 1 site in United States.
Trial summary
This proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (NDBI), Online RIT. Read more about this study
- Who is it for?
- Ages 16 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Online RIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2016to 30 Aug 2017
- 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 16 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Have a diagnosis of ASD or significant concerns of ASD
- Parent reported imitation deficits
Who cannot join
- Children of parents who are non-English speaking
- Actively participating in other parent training programs
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60657
About this study
Official title: Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial
This proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic behavioral approach to teach object and gesture imitation to young children with ASD within a play-based context. The efficacy of RIT has been demonstrated through a small randomized control trial, several single-subject design studies, as well as in independent replications. Prior research also suggests that parents can be taught to effectively use RIT with their children in person, and two single-subject design studies detail the development and feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest Online RIT may serve as an ideal platform for examining the potential of individualized telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to compare a stepped-care format of Online RIT to a waitlist control condition to determine initial feasibility and effectiveness of this innovative intervention and service delivery model.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Online RIT
- 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.
Online RITBehavioural
Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable "dashboard" that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log).
| Study group | Role | What they receive |
|---|---|---|
| Stepped-Care Online Reciprocal Imitation Training (Online RIT) | Experimental | Participants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a "step up" in care, in the form of remote parent coaching.
Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated <80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning. Receives: Behavioral: Online RIT |
| Wait List Control | No intervention | Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks
Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.
Measured: Baseline and 15 weeks
Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks
The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.
Measured: Baseline and 15 weeks
Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks
The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.
Measured: Baseline and 15 weeks
Secondary outcomes (2)
Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks
The SCC is a 47-item checklist completed by parents to indicate if a child uses a specific social communication skill.
Measured: Baseline and 15 weeks
Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks
The FQOL Scale is a 25-item self-report measure designed to assess family interaction, parenting, emotional well-being, physical/maternal well-being, and disability-related supports.
Measured: Baseline and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start10 Jan 2016
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Wainer, Ph.D., Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467073
- Sponsor's protocol ID
- 15100203
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wainer AL, Arnold ZE, Leonczyk C, Valluripalli Soorya L. Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial. Mol Autism. 2021 May 8;12(1):32. doi: 10.1186/s13229-021-00443-9.
PubMed 33964979
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT04467073
- Acronym / sponsor ID
- 15100203
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 10 Jul 2020 (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.
This proof-of-concept study addresses the gap in the access to care literature by examining a stepped-care version of a telehealth naturalistic developmental behavioral intervention (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic behavioral approach to teach object and gesture imitation to young children with ASD within a play-based context. The efficacy of RIT has been demonstrated through a small randomized control trial, several single-subject design studies, as well as in independent replications. Prior research also suggests that parents can be taught to effectively use RIT with their children in person, and two single-subject design studies detail the development and feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest Online RIT may serve as an ideal platform for examining the potential of individualized telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to compare a stepped-care format of Online RIT to a waitlist control condition to determine initial feasibility and effectiveness of this innovative intervention and service delivery model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped-Care Online Reciprocal Imitation Training (Online RIT) | Experimental | Behavioral: Online RITParticipants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a "step up" in care, in the form of remote parent coaching. Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated <80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning. |
| Wait List Control | No intervention | –Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses. |
Who may qualify
- Ages
- 16 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Have a diagnosis of ASD or significant concerns of ASD
- Parent reported imitation deficits
Key exclusion criteria (2 listed)
- Children of parents who are non-English speaking
- Actively participating in other parent training programs
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 |
|---|---|---|
| Online RITOnline RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable "dashboard" that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log). | Behavioural | Stepped-Care Online Reciprocal Imitation Training (Online RIT) |
Primary outcome
Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks
Time frame: Baseline and 15 weeks
Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.
Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks
Time frame: Baseline and 15 weeks
The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.
Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks
Time frame: Baseline and 15 weeks
The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.
2 secondary outcomes
Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks
Time frame: Baseline and 15 weeks
Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks
Time frame: Baseline and 15 weeks
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 10 Jul 2020.
- Derived from this study: PubMed 33964979Wainer AL, Arnold ZE, Leonczyk C, Valluripalli Soorya L. Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial. Mol Autism. 2021 May 8;12(1):32. doi: 10.1186/s13229-021-00443-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online RIT in people with Autism Spectrum Disorder, run by Rush University Medical Center 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 2 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: finished, as of the sponsor's last update on 10 Jul 2020. 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?
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 RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks (time frame: Baseline and 15 weeks). The study lists 3 primary outcomes in all. 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 NCT04467073, which also lists 1 linked publication.
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 10 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.