Autism Spectrum DisorderNCT03957993
OT Intervention Via Telehealth for Children With ASD and ADHD
A study testing Occupational Therapy via Telehealth in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study aims to measure the impact of a telehealth-based model of occupational therapy (OT) treatment on clinical outcomes for children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Occupational Therapy via Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 30 Dec 2019
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Has a Autism Spectrum Disorder and/or Attention Deficit Hyperactivity Disorder
- Has an active occupational therapy referral
- Has occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)
Who cannot join
- Does not have Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder
- Does not have an active occupational therapy referral
- Does not have occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Pilot Study: Addressing Home-Based Functional Challenges Via Telehealth-Based Occupational Therapy
This study aims to measure the impact of a telehealth-based model of occupational therapy (OT) treatment on clinical outcomes for children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Half of the participants will receive clinic-based, in-person services and half of the participants will receive video-based, Telehealth services.
Read the detailed description
Children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD) often receive occupational therapy (OT), which traditionally takes place in a clinical setting. This setting may present barriers and distractors that make it hard for children to achieve their OT goals. Telehealth-based sessions provide an alternative, allowing the therapist to be virtually present within the home.Once enrolled, children will randomly be assigned to be in one of two groups: (1) Standard, in which children will receive clinic-based services as per standard of care OR (2) Telehealth, in which children will receive in-home services on a video-based platform on a timeline identical to what they would receive if they were in the Standard group. Children in both groups will participate for the duration of the episode of care, estimated to last 10-12 weeks. Assessments will be completed at initial evaluation, discharge, and three months following discharge.
- Being tested
- Occupational Therapy via Telehealth, Standard of Care Occupational Therapy
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy via TelehealthOther
The caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist.
Standard of Care Occupational TherapyOther
The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy via Telehealth | Experimental | Participants in the telehealth-based model will undergo occupational therapy treatment via a telehealth-based video chat platform for the entire episode of care (generally 10-12 weeks in duration). The patient will use the video chat client to connect to his/her occupational therapist, and the therapist will conduct the session over this virtual connection. Receives: Other: Occupational Therapy via Telehealth |
| Standard of Care Occupational Therapy | Active comparator | Participants in the standard of care model will undergo occupational therapy treatment via traditional in- person encounters in an outpatient clinic setting for the entire episode of care (generally 10-12 weeks). These children will receive routine occupational treatment via in-person sessions with an occupational therapist conducted in an outpatient clinic setting. Receives: Other: Standard of Care Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Goal Attainment Scale
The Goal Attainment Scale is a criterion-referenced, individualized outcome measure used to assess progress on goals that are important to the child and their family. The Goal Attainment Scale is reliable, valid and responsive to change. The status of goal attainment is rated on a scale of +2 to -2 (+2 is much more than expected, -2 is much less than expected)
Measured: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
Change in Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure is a valid, reliable, and sensitive assessment tool that measures the caregiver/patient's perception of the participant's performance and satisfaction on goals that are important to the child and his/her caregiver. The performance and satisfaction are rated on a scale from 1-10 (1 is low performance/satisfaction, 10 is high performance/satisfaction).
Measured: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start6 Aug 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
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 Children's Hospital Medical Center, CincinnatiThe 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
- Model description
- Participants are randomized to the Telehealth arm of the study or the Standard Care arm of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Harpster, PhD, OTR/L, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957993
- Sponsor's protocol ID
- 2017-5623
- Status last verified
- Jun 2020
- First submitted
- 10 May 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Addressing Home-Based Functional Challenges Via Telehealth-Based Occupational Therapy
- ClinicalTrials.gov ID
- NCT03957993
- Acronym / sponsor ID
- 2017-5623
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 May 2019 (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 study aims to measure the impact of a telehealth-based model of occupational therapy (OT) treatment on clinical outcomes for children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Half of the participants will receive clinic-based, in-person services and half of the participants will receive video-based, Telehealth services.
Detailed description
Children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD) often receive occupational therapy (OT), which traditionally takes place in a clinical setting. This setting may present barriers and distractors that make it hard for children to achieve their OT goals. Telehealth-based sessions provide an alternative, allowing the therapist to be virtually present within the home.Once enrolled, children will randomly be assigned to be in one of two groups: (1) Standard, in which children will receive clinic-based services as per standard of care OR (2) Telehealth, in which children will receive in-home services on a video-based platform on a timeline identical to what they would receive if they were in the Standard group. Children in both groups will participate for the duration of the episode of care, estimated to last 10-12 weeks. Assessments will be completed at initial evaluation, discharge, and three months following discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to the Telehealth arm of the study or the Standard Care arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy via Telehealth | Experimental | Other: Occupational Therapy via TelehealthParticipants in the telehealth-based model will undergo occupational therapy treatment via a telehealth-based video chat platform for the entire episode of care (generally 10-12 weeks in duration). The patient will use the video chat client to connect to his/her occupational therapist, and the therapist will conduct the session over this virtual connection. |
| Standard of Care Occupational Therapy | Active comparator | Other: Standard of Care Occupational TherapyParticipants in the standard of care model will undergo occupational therapy treatment via traditional in- person encounters in an outpatient clinic setting for the entire episode of care (generally 10-12 weeks). These children will receive routine occupational treatment via in-person sessions with an occupational therapist conducted in an outpatient clinic setting. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Has a Autism Spectrum Disorder and/or Attention Deficit Hyperactivity Disorder
- Has an active occupational therapy referral
- Has occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)
Key exclusion criteria (3 listed)
- Does not have Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder
- Does not have an active occupational therapy referral
- Does not have occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)
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 |
|---|---|---|
| Occupational Therapy via TelehealthThe caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist. | Other | Occupational Therapy via Telehealth |
| Standard of Care Occupational TherapyThe caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist. | Other | Standard of Care Occupational Therapy |
Primary outcome
Change in Goal Attainment Scale
Time frame: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
The Goal Attainment Scale is a criterion-referenced, individualized outcome measure used to assess progress on goals that are important to the child and their family. The Goal Attainment Scale is reliable, valid and responsive to change. The status of goal attainment is rated on a scale of +2 to -2 (+2 is much more than expected, -2 is much less than expected)
Change in Canadian Occupational Performance Measure
Time frame: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
The Canadian Occupational Performance Measure is a valid, reliable, and sensitive assessment tool that measures the caregiver/patient's perception of the participant's performance and satisfaction on goals that are important to the child and his/her caregiver. The performance and satisfaction are rated on a scale from 1-10 (1 is low performance/satisfaction, 10 is high performance/satisfaction).
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 16 Jul 2020.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available to other researchers.
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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.
Karen Harpster, PhD, OTR/L principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy via Telehealth in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 3 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 16 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 in Goal Attainment Scale (time frame: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)). 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 16 Jul 2020.