Clinical trial NCT05056922: Telehealth Rapid Intervention for Externalizing Behaviors in ASD
Official title: THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Disruptive Behavior
Externalizing Behavior
Parent-Child Interaction Therapy
Telehealth
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2021-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
timeFrame: Pre-treatment to follow-up (~24 weeks)
measure: Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)
timeFrame: Pre-treatment to follow-up (~24 weeks)
measure: 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)
measure: 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)
measure: Change in Parenting Practices as assessed by Parenting Scale (PS)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Change in Parenting Practices as assessed by Parenting Scale (PS)
timeFrame: Pre-treatment to follow-up (~24 weeks)
measure: Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Pre-treatment to follow-up (~24 weeks)
measure: Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
timeFrame: Pre-treatment to follow-up (~24 weeks)
measure: Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
timeFrame: Pre-treatment to follow-up (~24 weeks)
Secondary outcomes:
measure: Parent Satisfaction with Tele-PCIT as assessed by Therapy Attitude Inventory (TAI)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
measure: Impact of Barriers on Treatment Engagement as assessed by Barriers to Treatment Participation Scale (BTPS)
timeFrame: Pre-treatment to post-treatment (~12 weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: