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 range2 Years – 83 Months

SexALL

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
✕. Children who are receiving psychotropic medication and are not stable on their current medication regimen. Children receiving psychotropic medications who are on a stable regimen for one month will not be excluded.

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)

Change in Parenting Practices as assessed by Parenting Scale (PS)

Timeframe: Pre-treatment to post-treatment (~12 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 range2 Years – 83 Months

SexALL

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
✕. Children who are receiving psychotropic medication and are not stable on their current medication regimen. Children receiving psychotropic medications who are on a stable regimen for one month will not be excluded.

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)

Change in Parenting Practices as assessed by Parenting Scale (PS)

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