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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268796
• Other study ID #: AR210221
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2024
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Scott Hall, PhD
• Phone: 650-498-4799
• Email: hallss[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion criteria:

1. Child is aged 3 years, 0 months to 5 years, 11 months inclusive

2. Child has a diagnosis of ASD (confirmed by diagnostic report)

3. Child is reported to exhibit at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the Behavior Problems Inventory -Short Form (BPI-S).

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, or Dona Ana

5. Caregiver is comfortable speaking and reading in English

6. The child's primary 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. The child's primary 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

7. Child has a sibling or twin already participating in the study

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Behavior 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.

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

Locations

Country	Name	City	State
United States	Behavior Change Institute	Alamogordo	New Mexico
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Behavior Change Institute, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of challenging behavior	In-session observations of challenging behavior	4 week intervals
Primary	Parenting Stress Index	Severity of parent stress	Previous 4 weeks