OT Via Telehealth (ASD and ADHD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03957993|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder||Other: Occupational Therapy via Telehealth Other: Standard of Care Occupational Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized to the Telehealth arm of the study or the Standard Care arm of the study.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The therapist who assesses the outcomes is a different therapist than the treating (intervention) therapist.|
|Official Title:||Pilot Study: Addressing Home-Based Functional Challenges Via Telehealth-Based Occupational Therapy|
|Actual Study Start Date :||August 6, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Occupational Therapy via Telehealth
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.
Other: Occupational Therapy via Telehealth
The caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist.
Active Comparator: Standard of Care Occupational Therapy
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.
Other: Standard of Care Occupational Therapy
The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957993
|Contact: Karen L Harpster, PhD, OTR/Lemail@example.com|
|Contact: Jason Long, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Karen L Harpster, PhD, OTR/L 513-803-3604 email@example.com|
|Contact: Jason Long, PhD 513-803-3595 firstname.lastname@example.org|