NCT05268796 Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
| NCT ID | NCT05268796 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Stanford University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-01-05 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05268796 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 7 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05268796 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05268796 currently recruiting?
Yes, NCT05268796 is actively recruiting participants. Contact the research team at hallss@stanford.edu for enrollment information.
Where is the NCT05268796 trial being conducted?
This trial is being conducted at Stanford, United States, Alamogordo, United States.
Who is sponsoring the NCT05268796 clinical trial?
NCT05268796 is sponsored by Stanford University. The trial plans to enroll 90 participants.