Comparing telehealth and in-person behavior therapy for children with autism
Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder
This study is testing whether behavior therapy delivered online is as helpful as in-person therapy for young children with autism who have challenging behaviors.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 2 Years to 7 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Stanford, California and 1 other locations) |
| Trial ID | NCT05268796 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of parent-mediated behavior therapy for challenging behaviors in children with Autism Spectrum Disorder (ASD) when delivered via telehealth compared to traditional in-person sessions. The study will involve caregivers working with clinicians over a 12-week period, focusing on children aged 2 to 7 years who exhibit self-injurious or aggressive behaviors. Participants will be required to engage in weekly sessions, either in their homes or through telehealth platforms, to assess the impact of the intervention on the child's behavior.
Who should consider this trial
Good fit: Ideal candidates include children aged 2 to 7 years with a documented diagnosis of ASD who exhibit significant challenging behaviors and have a caregiver willing to participate in the intervention.
Not a fit: Patients who do not exhibit self-injurious or aggressive behaviors or those whose caregivers are unable to commit to the study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and flexible treatment option for families dealing with challenging behaviors in children with ASD.
How similar studies have performed: Other studies have shown promising results for telehealth interventions in behavioral therapies, suggesting that this approach may be effective, though this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California and 1 other locations
- Stanford University — Stanford, California, United States (Recruiting)
- Behavior Change Institute — Alamogordo, New Mexico, United States (Active_not_recruiting)
Study contacts
- Study coordinator: Scott Hall, PhD
- Email: hallss@stanford.edu
- Phone: 650-498-4799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.