Autism Spectrum DisorderPhase 2/3NCT05268796
Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
A Phase 2/3 study testing Behavior therapy and Psychoeducation in people with Autism Spectrum Disorder, run by Stanford University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Behavior therapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2024to Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is aged 2 years 0 months to 7 years 11 months inclusive
- Child has a documented diagnosis of ASD
- 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
- 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.
- Caregiver is comfortable speaking and reading in English
- The child's caregiver is at least 21 years old
Show all 9Show fewer
- 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
- 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
- Family lives in an area with consistent cell phone coverage
Who cannot join
- Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
- 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.
- 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)
- Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
- Child has an underlying medical condition that is better treated with medical intervention
- Child only exhibits pica at a daily or hourly frequency on the BPI-S
- The caregiver has another child already participating in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
Behavior Change Institute
Alamogordo, New Mexico, 88310
- Recruiting
Stanford University
Stanford, California, 94305
Scott S Hall, phD, 650-498-4799
Scott S Hall, PhD
About this study
Official title: Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder
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
- Being tested
- Behavior therapy, Psychoeducation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior therapyBehavioural
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.
PsychoeducationOther
Caregivers will complete online education modules in 1-hour sessions each week over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| In-person treatment | Active comparator | Not described Receives: Behavioral: Behavior therapy |
| Telehealth-enabled treatment | Active comparator | Not described Receives: Behavioral: Behavior therapy |
| Psychoeducation | Placebo comparator | Not described Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of challenging behavior
In-session observations of challenging behavior
Measured: 4 week intervals
Parenting Stress Index
Severity of parent stress
Measured: Previous 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start5 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Behavior Change Institute, United States Department of Defense
- Responsible party
- Principal investigator, Scott Hall, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268796
- Sponsor's protocol ID
- AR210221
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollard JS, Quiroz LS, Boyd JA, Jo B, Hall SS. Telehealth Versus In-Person Caregiver-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder: Protocol for COACH (Caregiver Outreach for Autism Coaching at Home) Randomized Controlled Trial. JMIR Res Protoc. 2026 May 26;15:e91840. doi: 10.2196/91840.
PubMed 42190642
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05268796
- Acronym / sponsor ID
- AR210221
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Behavior Change Institute, United States Department of Defense
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person treatment | Active comparator | Behavioral: Behavior therapy |
| Telehealth-enabled treatment | Active comparator | Behavioral: Behavior therapy |
| Psychoeducation | Placebo comparator | Other: Psychoeducation |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Child is aged 2 years 0 months to 7 years 11 months inclusive
- Child has a documented diagnosis of ASD
- 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
- 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.
- Caregiver is comfortable speaking and reading in English
Key exclusion criteria (7 listed)
- Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
- 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.
- 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)
- Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
- Child has an underlying medical condition that is better treated with medical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior therapyCaregivers 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. | Behavioural | In-person treatment, Telehealth-enabled treatment |
| PsychoeducationCaregivers will complete online education modules in 1-hour sessions each week over 12 weeks. | Other | Psychoeducation |
Primary outcome
Frequency of challenging behavior
Time frame: 4 week intervals
In-session observations of challenging behavior
Parenting Stress Index
Time frame: Previous 4 weeks
Severity of parent stress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 42190642Pollard JS, Quiroz LS, Boyd JA, Jo B, Hall SS. Telehealth Versus In-Person Caregiver-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder: Protocol for COACH (Caregiver Outreach for Autism Coaching at Home) Randomized Controlled Trial. JMIR Res Protoc. 2026 May 26;15:e91840. doi: 10.2196/91840.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Behavior therapy and Psychoeducation in people with Autism Spectrum Disorder, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Hall, PhD (650-498-4799, hallss@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of challenging behavior (time frame: 4 week intervals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.