Clinical trial NCT03957993: OT Intervention Via Telehealth for Children With ASD and ADHD
Official title: Pilot Study: Addressing Home-Based Functional Challenges Via Telehealth-Based Occupational Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to the Telehealth arm of the study or the Standard Care arm of the study.
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Goal Attainment Scale
timeFrame: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
measure: Change in Canadian Occupational Performance Measure
timeFrame: Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Karen Harpster, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: