Telehealth Intervention for Disruptive Behavior in Autism

(THRIVE-ASD Trial)

Overseen By Rosmary Ros-Demarize, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Unstable psychotropics

Disqualifiers: Severe self-injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for young children aged 2 to almost 7 with Autism Spectrum Disorder (ASD) who show disruptive behaviors. They must have a confirmed ASD diagnosis, understand language at a two-year-old level, come from low-income families on Medicaid, and not be on unstable psychotropic medications or exhibit severe self-injury.

Inclusion Criteria

Are of low SES background defined by having primary Medicaid

Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory

My child is between 2 and 6 years old.

Exclusion Criteria

My child is on psychotropic medication but hasn't been stable on it for a month.

I engage in severe self-harm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of Tele-PCIT or Treatment as Usual

12 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Post-treatment assessment

Assessment of child compliance, behavior problems, and parenting practices

1-2 weeks

Treatment Details

Interventions

• Tele-PCIT
• Treatment as Usual

Trial Overview The study tests a short version of Parent Child Interaction Therapy (PCIT) done through telehealth against the usual treatment methods for managing disruptive behaviors in kids with ASD. Participants will be randomly placed into one of these two groups and assessed before, after treatment, and three months later.

Participant Groups

Group I: Tele-PCIT (Parent-Child Interaction Therapy) Experimental Treatment 1 Intervention

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+