Autism Spectrum DisorderNCT04832152
Telehealth Intervention for Autism Spectrum Disorder
A study testing OT4ASD in people with Autism Spectrum Disorder, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children. Most children with ASD experience challenges participating in daily activities (e.g.: eating, sleeping, bathing, grooming, playing, etc.) and receive occupational… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- OT4ASD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Jun 2024
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of Autism Spectrum Disorder
- Between the ages of 4 years 0 months and 12 years 0 months
- Evidence of sensory symptoms based on the Sensory Processing Measure
- Family is willing to participate
- Physically able to participate in active, sensorimotor activities
Who cannot join
- Primary (visual or auditory) uncorrected sensory deficits
- Do not meet age or diagnostic criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rose R. Kennedy Children's Evaluation and Rehabilitation Center (CERC) at Montefiore
The Bronx, New York, 10461
Elizabeth C Ridgway, OTD, 718-839-7101, elizabeth.ridgway@einsteinmed.org
Daniella Soba, OTD, 718-839-7104, dsoba@montefiore.org
About this study
Official title: Testing the Feasibility of a Teletherapy Plus Parent Coaching Intervention for Children With Autism
Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children. Most children with ASD experience challenges participating in daily activities (e.g.: eating, sleeping, bathing, grooming, playing, etc.) and receive occupational therapy intervention to address these. The COVID-19 pandemic has restricted in-person therapy for many of these children and there is an urgent need for evidence-based, validated telehealth intervention. This project will adapt an evidence-based occupational therapy intervention, termed OT4ASD to a telehealth delivery model. The aims of the project are to: 1) adapt the existing intervention protocol to a telehealth delivery model, 2) train therapists and evaluate the therapist's ability to conduct OT4ASD, 3) determine if OT4ASD delivered via the telehealth is acceptable and feasible to parents and interventionists; and 4) whether children improve in the daily living skills. OT4ASD follows a systematic protocol and uses active, individually-tailored sensory motor activities that are specifically designed to address the child's needs. The investigators believe this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the daily life activity and participation levels.
Read the detailed description
Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children1. As a lifelong condition, individuals with ASD experience a range of intellectual, behavioral, sensory, motor, and functional challenges that impact successful participation in daily life activities and tasks. As a result, occupational therapy (OT) intervention is a frequently requested and utilized service in ASD, and clinically validated OT approaches are needed. In a series of studies funded by the NIH and autism foundations, our team manualized and studied an OT intervention that targets the sensory and motor factors impacting participation in daily life activities and tasks and showed significant improvements in those that received the intervention in comparison to controls 2-4. In this project, the investigators plan to adapt our existing protocol to a telehealth model of service delivery, and evaluate its feasibility and preliminary effectiveness.
The COVID-19 global pandemic created a call to action for healthcare providers to design unique and innovative methods for therapeutic service delivery. This shift creates an urgent need for remote solutions so that therapeutic services can be delivered in safely and effectively. Since the onset of the COVID-19 pandemic, families have reported regression in adaptive functioning in addition to a negative impact on social skills and increased anxiety, and an impact to daily routines of children with ASD5. In a recent survey of families with children with ASD, 95% of the parents reported that disruptions in services/therapies negatively impacted their child's behaviors and only 35% of families were receiving telehealth services/therapies6. To address these increased needs for children with ASD and to meet the need of manualized telehealth intervention, the investigators propose to adapt the existing intervention to a telehealth delivery model. This intervention, termed occupational therapy for children with Autism Spectrum Disorder (OT4ASD) targets the sensory motor factors that impact behavior and participation in life activities and tasks. This project is significant in that it will address the need for evidence-based OT services for children with ASD using an innovative telehealth model. Given that many children with ASD require treatment for the sensory and motor symptoms that impact their optimal participation in a range of daily life activities and tasks, and that the current COVID 19 pandemic has compromised access to this therapy, this project is urgently needed.
Innovation: Telehealth offers an emerging and innovative approach for OT intervention. Research shows that children with ASD require intensive intervention to assure best outcomes and telehealth offers an innovative solution for providing therapy during a pandemic. To the investigator's knowledge, this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the activity and participation levels of the ICF framework. Importantly, the investigators will adapt an evidence-based, manualized intervention with solid data on outcomes to a telehealth model. The protocol will operationalize the data-driven decision making (DDDM) approach into an on-line format. DDDM is innovative in that it explicitly guides the therapist to contextualize intervention within the child and family's real life participation challenges and use data from assessment to individualize the intervention. DDDM measures outcomes at the proximal (sensory and motor factors) and distal (functional/participation-based goals) levels facilitating an intervention that is context-specific and participation-oriented.
Methods: The project will first adapt the existing protocol into a telehealth delivery model using a formative approach that includes a modified Delphi process to obtain input and consensus from experts in telehealth and autism interventions and key stakeholders (parents and clinical interventionists). Next, the investigators will conduct a feasibility trial to assess the acceptability, satisfaction and implementation fidelity as well as gather data on clinically meaningful outcomes. Outcomes will be measured at the proximal and distal levels using validated outcome measures to assure information gained is relevant and scientifically rigorous. Data from the feasibility trial will be used to support an R01 application to conduct a randomized trial of OT4ASD.
To implement the project, the investigators utilize a highly skilled team of clinicians and scientists with experience in conducting randomized trials in autism who will work collaboratively to translate knowledge gained into useful information that will impact the lives of families and children with ASD. Our approach is consistent with contemporary models of evidence-based practice and rehabilitation science promoting promote high integrity, evidence-based information from research that targets relevant and meaningful areas for each child and family. The timeline is ambitious and the investigators feel well-equipped to meet it given past experiences and expertise.
In summary, this project addresses an urgent need to provide rehabilitation services to children with ASD using remote technology. It will operationalize best practices in telehealth to adapt an existing evidence-based OT intervention and utilize a skilled and experienced team of investigators. As such, this project is consistent with the AACPDM mission to promote excellence in research and services for persons with childhood-onset disabilities.
- Conditions
- Autism Spectrum Disorder
- Being tested
- OT4ASD
- 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.
OT4ASDOther
Occupational therapy will focus on education and coaching of families/caregivers of children with autism spectrum disorder to help them adapt their daily routines to address their child's sensory needs.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility trial group | Other | One group (arm) trial where all will receive treatment. Receives: Other: OT4ASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Living Skills Change Score - Pediatric Evaluation of Disabilities Inventory
Change in daily living skills (on a scale of 0 to 25) measured with the Pediatric Evaluation of Disabilities Inventory. Change score range 0-25; higher score means better outcome.
Measured: up to 14 weeks
Pervasive Developmental Disorders Behavioral Inventory T Score Autism Behaviors
Change is autism behaviors and sensory approach behaviors. Raw scores are converted to T Score. Minimum = 10 Maximum = 80
Measured: up to 14 weeks
Secondary outcomes (2)
Goal Attainment Scale T Score
Rating of individual goals. Rating Scale -2 to +2 is converted to T-Score; higher score means better outcome.
Measured: up to 14 weeks
Sensory Processing Measure
Change in sensory hypo or hyper reactivity. T scores range from 40 to 80; Lower score means better outcome.
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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 Thomas Jefferson UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The purpose of this project is to adapt an existing, evidence-based occupational therapy intervention for children with ASD to a telehealth delivery model. The main objectives of the project are to 1) adapt the manual so that it operationalizes best-practices of occupational therapy telehealth50,51, 2) test its feasibility, and 3) evaluate preliminary outcomes. Design: In the formative research aspect of this project will use survey methodology and a modified Delphi process to adapt our current intervention to a telehealth delivery model (Aim 1). In Aim 2 we will conduct a feasibility trial (Figure 2) to assess therapists' fidelity, participant recruitment and retention, acceptability of the protocol by parents and therapists, and clinically meaningful differences.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832152
- Sponsor's protocol ID
- 412579-19406
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in high impact autism journal, and presentation at international autism research meetings.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Teletherapy Plus Parent Coaching Intervention for Children With Autism
- ClinicalTrials.gov ID
- NCT04832152
- Acronym / sponsor ID
- 412579-19406
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 5 Apr 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.
Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children. Most children with ASD experience challenges participating in daily activities (e.g.: eating, sleeping, bathing, grooming, playing, etc.) and receive occupational therapy intervention to address these. The COVID-19 pandemic has restricted in-person therapy for many of these children and there is an urgent need for evidence-based, validated telehealth intervention. This project will adapt an evidence-based occupational therapy intervention, termed OT4ASD to a telehealth delivery model. The aims of the project are to: 1) adapt the existing intervention protocol to a telehealth delivery model, 2) train therapists and evaluate the therapist's ability to conduct OT4ASD, 3) determine if OT4ASD delivered via the telehealth is acceptable and feasible to parents and interventionists; and 4) whether children improve in the daily living skills. OT4ASD follows a systematic protocol and uses active, individually-tailored sensory motor activities that are specifically designed to address the child's needs. The investigators believe this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the daily life activity and participation levels.
Detailed description
Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children1. As a lifelong condition, individuals with ASD experience a range of intellectual, behavioral, sensory, motor, and functional challenges that impact successful participation in daily life activities and tasks. As a result, occupational therapy (OT) intervention is a frequently requested and utilized service in ASD, and clinically validated OT approaches are needed. In a series of studies funded by the NIH and autism foundations, our team manualized and studied an OT intervention that targets the sensory and motor factors impacting participation in daily life activities and tasks and showed significant improvements in those that received the intervention in comparison to controls 2-4. In this project, the investigators plan to adapt our existing protocol to a telehealth model of service delivery, and evaluate its feasibility and preliminary effectiveness.
The COVID-19 global pandemic created a call to action for healthcare providers to design unique and innovative methods for therapeutic service delivery. This shift creates an urgent need for remote solutions so that therapeutic services can be delivered in safely and effectively. Since the onset of the COVID-19 pandemic, families have reported regression in adaptive functioning in addition to a negative impact on social skills and increased anxiety, and an impact to daily routines of children with ASD5. In a recent survey of families with children with ASD, 95% of the parents reported that disruptions in services/therapies negatively impacted their child's behaviors and only 35% of families were receiving telehealth services/therapies6. To address these increased needs for children with ASD and to meet the need of manualized telehealth intervention, the investigators propose to adapt the existing intervention to a telehealth delivery model. This intervention, termed occupational therapy for children with Autism Spectrum Disorder (OT4ASD) targets the sensory motor factors that impact behavior and participation in life activities and tasks. This project is significant in that it will address the need for evidence-based OT services for children with ASD using an innovative telehealth model. Given that many children with ASD require treatment for the sensory and motor symptoms that impact their optimal participation in a range of daily life activities and tasks, and that the current COVID 19 pandemic has compromised access to this therapy, this project is urgently needed.
Innovation: Telehealth offers an emerging and innovative approach for OT intervention. Research shows that children with ASD require intensive intervention to assure best outcomes and telehealth offers an innovative solution for providing therapy during a pandemic. To the investigator's knowledge, this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the activity and participation levels of the ICF framework. Importantly, the investigators will adapt an evidence-based, manualized intervention with solid data on outcomes to a telehealth model. The protocol will operationalize the data-driven decision making (DDDM) approach into an on-line format. DDDM is innovative in that it explicitly guides the therapist to contextualize intervention within the child and family's real life participation challenges and use data from assessment to individualize the intervention. DDDM measures outcomes at the proximal (sensory and motor factors) and distal (functional/participation-based goals) levels facilitating an intervention that is context-specific and participation-oriented.
Methods: The project will first adapt the existing protocol into a telehealth delivery model using a formative approach that includes a modified Delphi process to obtain input and consensus from experts in telehealth and autism interventions and key stakeholders (parents and clinical interventionists). Next, the investigators will conduct a feasibility trial to assess the acceptability, satisfaction and implementation fidelity as well as gather data on clinically meaningful outcomes. Outcomes will be measured at the proximal and distal levels using validated outcome measures to assure information gained is relevant and scientifically rigorous. Data from the feasibility trial will be used to support an R01 application to conduct a randomized trial of OT4ASD.
To implement the project, the investigators utilize a highly skilled team of clinicians and scientists with experience in conducting randomized trials in autism who will work collaboratively to translate knowledge gained into useful information that will impact the lives of families and children with ASD. Our approach is consistent with contemporary models of evidence-based practice and rehabilitation science promoting promote high integrity, evidence-based information from research that targets relevant and meaningful areas for each child and family. The timeline is ambitious and the investigators feel well-equipped to meet it given past experiences and expertise.
In summary, this project addresses an urgent need to provide rehabilitation services to children with ASD using remote technology. It will operationalize best practices in telehealth to adapt an existing evidence-based OT intervention and utilize a skilled and experienced team of investigators. As such, this project is consistent with the AACPDM mission to promote excellence in research and services for persons with childhood-onset disabilities.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The purpose of this project is to adapt an existing, evidence-based occupational therapy intervention for children with ASD to a telehealth delivery model. The main objectives of the project are to 1) adapt the manual so that it operationalizes best-practices of occupational therapy telehealth50,51, 2) test its feasibility, and 3) evaluate preliminary outcomes. Design: In the formative research aspect of this project will use survey methodology and a modified Delphi process to adapt our current intervention to a telehealth delivery model (Aim 1). In Aim 2 we will conduct a feasibility trial (Figure 2) to assess therapists' fidelity, participant recruitment and retention, acceptability of the protocol by parents and therapists, and clinically meaningful differences.
| Arm | Type | Receives |
|---|---|---|
| Feasibility trial group | Other | Other: OT4ASDOne group (arm) trial where all will receive treatment. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of Autism Spectrum Disorder
- Between the ages of 4 years 0 months and 12 years 0 months
- Evidence of sensory symptoms based on the Sensory Processing Measure
- Family is willing to participate
- Physically able to participate in active, sensorimotor activities
Key exclusion criteria (2 listed)
- Primary (visual or auditory) uncorrected sensory deficits
- Do not meet age or diagnostic criteria
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 |
|---|---|---|
| OT4ASDOccupational therapy will focus on education and coaching of families/caregivers of children with autism spectrum disorder to help them adapt their daily routines to address their child's sensory needs. | Other | Feasibility trial group |
Primary outcome
Daily Living Skills Change Score - Pediatric Evaluation of Disabilities Inventory
Time frame: up to 14 weeks
Change in daily living skills (on a scale of 0 to 25) measured with the Pediatric Evaluation of Disabilities Inventory. Change score range 0-25; higher score means better outcome.
Pervasive Developmental Disorders Behavioral Inventory T Score Autism Behaviors
Time frame: up to 14 weeks
Change is autism behaviors and sensory approach behaviors. Raw scores are converted to T Score. Minimum = 10 Maximum = 80
2 secondary outcomes
Goal Attainment Scale T Score
Time frame: up to 14 weeks
Sensory Processing Measure
Time frame: up to 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Yes. Publication in high impact autism journal, and presentation at international autism research meetings.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OT4ASD in people with Autism Spectrum Disorder, run by Thomas Jefferson University 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 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roseann C Schaaf, PhD (6102912179, roseann.schaaf@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Living Skills Change Score - Pediatric Evaluation of Disabilities Inventory (time frame: up to 14 weeks). The study lists 2 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 22 Apr 2024.