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Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD

Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05268796
Enrollment
90
Registered
2022-03-07
Start date
2024-01-05
Completion date
2026-06-30
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

BEHAVIORALBehavior therapy

Caregivers will be coached either in-person or via telehealth to implement function-based behavioral treatment in 1-hour sessions each week with their child over 12 weeks.

OTHERPsychoeducation

Caregivers will complete online education modules in 1-hour sessions each week over 12 weeks.

Sponsors

Behavior Change Institute
CollaboratorUNKNOWN
United States Department of Defense
CollaboratorFED
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of challenging behavior4 week intervalsIn-session observations of challenging behavior
Parenting Stress IndexPrevious 4 weeksSeverity of parent stress

Countries

United States

Contacts

Primary ContactScott Hall, PhD
hallss@stanford.edu650-498-4799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026