Clinical trial NCT05268796: Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
Official title: Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Autism Spectrum Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Behavior Change Institute
name: United States Department of Defense
First posted: 2022-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person.


Eligibility criteria: Inclusion criteria:

1. Child is aged 2 years 0 months to 7 years 11 months inclusive
2. Child has a documented diagnosis of ASD
3. Child exhibits at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the Behavior Problems Inventory - Short Form (BPI-S)71,72
4. Family lives in one of the following counties in New Mexico and Texas: Bernalillo, Santa Fe, Valencia, Sandoval, Torrance, Socorro, Cibola, Los Alamos, El Paso, Hudspeth, Otero, McKinley, San Miguel, Eddy, Chaves, or Dona Ana.
5. Caregiver is comfortable speaking and reading in English
6. The child's caregiver is at least 21 years old
7. The same caregiver is consistently available for one hour per week for a 12-week period in their home with their child between 9am and 7pm Monday through Friday to take part in the research
8. Caregiver is willing to adhere to the study intervention regimen and be willing to have a clinician come into their home for 1 hour per week for 12 weeks
9. Family lives in an area with consistent cell phone coverage

Exclusion criteria:

1. Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
2. Child engages in behavior that may inflict moderate to severe damage on the individual or on other people (e.g. biting through the skin, eye gouging, fracturing bones, significant damage to property) with minor or major medical intervention required.
3. Child has a sensory or physical impairment that precludes participation (e.g., epilepsy, vision or hearing impairment) or has a diagnosis of another genetic condition (e.g., fragile X syndrome)
4. Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
5. Child has an underlying medical condition that is better treated with medical intervention
6. Child only exhibits pica at a daily or hourly frequency on the BPI-S
7. The caregiver has another child already participating in the study

Primary outcomes:
measure: Frequency of challenging behavior
timeFrame: 4 week intervals
measure: Parenting Stress Index
timeFrame: Previous 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Alamogordo
country: United States
facility: Behavior Change Institute
state: New Mexico
Study officials:
References: