Telehealth Rapid Intervention for Externalizing Behaviors in ASD

NCT ID: NCT05056922

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2025-09-22

Brief 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.

Conditions

Autism Spectrum Disorder; Disruptive Behavior; Externalizing Behavior; Parent-Child Interaction Therapy; Telehealth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tele-PCIT (Parent-Child Interaction Therapy)

Group Type: EXPERIMENTAL

Tele-PCIT

Intervention Type: BEHAVIORAL

Families randomized to Tele-PCIT will receive a time-limited version of PCIT via telehealth. The first 5 sessions focus on the child directed interaction (CDI) phase. The first session includes a teaching session where the parent will learn PRIDE/"Do" skills and "Don't" skills. The next 4 CDI sessions include coaching where the therapist coaches the parent on the these skills within the context of play. The first PDI session includes a teaching session where parents will be given instructions for providing commands and timeout procedures. During the 4 PDI coaching sessions, the therapist coaches the parent through timeout procedures. Handouts are emailed to families throughout therapy. The treatment period is 12 weeks to complete the 10 sessions to account for scheduling challenges. Families will be provided a Bluetooth headset for sessions. Families who do not have access to a computer, tablet, or smartphone with internet access will be provided with a tablet for therapy use.

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Families randomized to Treatment-as-Usual (TAU) will receive brief feedback and psychoeducation during the baseline visit and will be provided with community resources and referrals as needed. The TAU procedures will reflect the level of care families receive after an ASD assessment or professional consultation in our own clinic. For addressing behavioral concerns specifically, families will be provided handouts on behavior management tips, given access to a webinar workshop reviewing basic behavioral parenting principles, and instructed to engage with available services. The Vanderbilt Treatment \& Research Institute for ASD (TRIAD) Center offers a webinar series for managing challenging behaviors that parents will be directed to along with the Autism Speaks Challenging Behavior Toolkit handouts. The TAU period will be 12 weeks in length to match time specifications for the active treatment condition.

Interventions

Tele-PCIT

Families randomized to Tele-PCIT will receive a time-limited version of PCIT via telehealth. The first 5 sessions focus on the child directed interaction (CDI) phase. The first session includes a teaching session where the parent will learn PRIDE/"Do" skills and "Don't" skills. The next 4 CDI sessions include coaching where the therapist coaches the parent on the these skills within the context of play. The first PDI session includes a teaching session where parents will be given instructions for providing commands and timeout procedures. During the 4 PDI coaching sessions, the therapist coaches the parent through timeout procedures. Handouts are emailed to families throughout therapy. The treatment period is 12 weeks to complete the 10 sessions to account for scheduling challenges. Families will be provided a Bluetooth headset for sessions. Families who do not have access to a computer, tablet, or smartphone with internet access will be provided with a tablet for therapy use.

Intervention Type: BEHAVIORAL

Treatment as Usual

Families randomized to Treatment-as-Usual (TAU) will receive brief feedback and psychoeducation during the baseline visit and will be provided with community resources and referrals as needed. The TAU procedures will reflect the level of care families receive after an ASD assessment or professional consultation in our own clinic. For addressing behavioral concerns specifically, families will be provided handouts on behavior management tips, given access to a webinar workshop reviewing basic behavioral parenting principles, and instructed to engage with available services. The Vanderbilt Treatment \& Research Institute for ASD (TRIAD) Center offers a webinar series for managing challenging behaviors that parents will be directed to along with the Autism Speaks Challenging Behavior Toolkit handouts. The TAU period will be 12 weeks in length to match time specifications for the active treatment condition.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Be between 2:0 -6:11 years old

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

3. 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.

4. Have a receptive language age equivalent of at least 24 months as defined by the Peabody Picture Vocabulary Test

5. Are of low SES background defined by having primary Medicaid

Exclusion Criteria

1. Presence of severe self-injurious behavior

2. 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 83 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R41MC42775-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

00114600

Identifier Type: -

Identifier Source: org_study_id