CompletedNot Applicable

Telehealth Rapid Intervention for Externalizing Behaviors in ASD

United States80 participantsStarted 2022-02-11

Plain-language summary

The purpose of this research study is to evaluate a time-limited version of Parent Child Interaction Therapy (PCIT) delivered via telehealth for young children with autism spectrum disorder (ASD) and disruptive behavior problems. Families will be randomly assigned to receive 10 sessions of Tele-PCIT or Treatment as Usual. Families will complete a baseline assessment, a post-treatment assessment, and a 3-month follow-up.

Who can participate

Age range

2 Years – 83 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be between 2:0 -6:11 years old
. Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory
. Have a diagnosis of ASD based on a positive Autism Diagnostic Observation Schedule (ADOS-2), a semi-structured parent interview, record review, and an ASD DSM-5 criteria checklist.
. Have a receptive language age equivalent of at least 24 months as defined by the Peabody Picture Vocabulary Test
. Are of low SES background defined by having primary Medicaid

Exclusion criteria

. Presence of severe self-injurious behavior

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)

Timeframe: Pre-treatment to post-treatment (~12 weeks)

Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)

Timeframe: Pre-treatment to follow-up (~24 weeks)

Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)

Timeframe: Pre-treatment to post-treatment (~12 weeks)

Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)

Timeframe: Pre-treatment to follow-up (~24 weeks)

Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)

Timeframe: Pre-treatment to post-treatment (~12 weeks)

Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)

Timeframe: Pre-treatment to follow-up (~24 weeks)

Trial details

NCT IDNCT05056922

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-22

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

2 Years – 83 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be between 2:0 -6:11 years old
. Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory
. Have a diagnosis of ASD based on a positive Autism Diagnostic Observation Schedule (ADOS-2), a semi-structured parent interview, record review, and an ASD DSM-5 criteria checklist.
. Have a receptive language age equivalent of at least 24 months as defined by the Peabody Picture Vocabulary Test
. Are of low SES background defined by having primary Medicaid

Exclusion criteria

. Presence of severe self-injurious behavior

What they're measuring

Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)

Timeframe: Pre-treatment to post-treatment (~12 weeks)

Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)

Timeframe: Pre-treatment to follow-up (~24 weeks)

Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)

Timeframe: Pre-treatment to post-treatment (~12 weeks)

Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)

Timeframe: Pre-treatment to follow-up (~24 weeks)

Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)

Timeframe: Pre-treatment to post-treatment (~12 weeks)

Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)

Timeframe: Pre-treatment to follow-up (~24 weeks)