Recruiting
Phase 2
Phase 3

Telehealth & In-Person

Sponsor:

Stanford University

Code:

NCT05268796

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Not accepted

Interventions

Behavior therapy

Psychoeducation

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT05268796

Start date

Jan 5, 2024

Status verified date

Aug, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: In-person treatment

active comparator: Telehealth-enabled treatment

placebo comparator: Psychoeducation

Interventions

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.

Psychoeducation

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

Primary outcome measure

  • Frequency of challenging behavior [ Time Frame: 4 week intervals ]
  • Parenting Stress Index [ Time Frame: Previous 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Scott S Hall, phD

650-498-4799

Principal Investigator:

Scott S Hall, PhD

More Information

Sponsor

Stanford University

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2024-08-27.