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Compares treatment options for Autism Spectrum Disorder
Official title Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
ClinicalTrials.gov ID: NCT05268796
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 7
You may be able to join if
- Child is aged 2 years 0 months to 7 years 11 months inclusive
- Child has a documented diagnosis of ASD
- Child exhibits at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the Behavior Problems Inventory - Short...
- Family lives in one of the following counties in New Mexico and Texas: Bernalillo, Santa Fe, Valencia, Sandoval, Torrance, Socorro, Cibola, Los...
- Caregiver is comfortable speaking and reading in English
You likely can't join if
- Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
- 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...
- Child has a sensory or physical impairment that precludes participation (e.g., epilepsy, vision or hearing impairment) or has a diagnosis of another...
- Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
- Child has an underlying medical condition that is better treated with medical intervention
- Child only exhibits pica at a daily or hourly frequency on the BPI-S
See the full eligibility criteria
- Child is aged 2 years 0 months to 7 years 11 months inclusive
- Child has a documented diagnosis of ASD
- 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
- 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...
- Caregiver is comfortable speaking and reading in English
- The child's caregiver is at least 21 years old
- 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
- 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
- Family lives in an area with consistent cell phone coverage
- Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
- 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...
- 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)
- Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
- Child has an underlying medical condition that is better treated with medical intervention
- Child only exhibits pica at a daily or hourly frequency on the BPI-S
- The caregiver has another child already participating in the study
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Alamogordo, New Mexico, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Alamogordo, New Mexico, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.