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Telehealth Rapid Intervention for Externalizing Behaviors in ASD (THRIVE-ASD)

Primary Purpose

Autism Spectrum Disorder, Disruptive Behavior, Externalizing Behavior

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-PCIT
Treatment as Usual
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 83 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-PCIT (Parent-Child Interaction Therapy)

Treatment as Usual

Arm Description

Outcomes

Primary Outcome Measures

Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
The ECBI is a 36-item measure of disruptive behavior problems utilized across the PCIT literature. Parents will rate the frequency of child behaviors on a 7-point Likert scale. The ECBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity. The cut-off for clinical significance is a raw score of 130.
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
The ECBI is a 36-item measure of disruptive behavior problems utilized across the PCIT literature. Parents will rate the frequency of child behaviors on a 7-point Likert scale. The ECBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity. The cut-off for clinical significance is a raw score of 130.
Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)
The SESBI is a 38-item measure of disruptive behavior utilized across the PCIT literature. Teachers will rate the current frequency of child behavior problems on a 7-point Likert scale and determine whether or not they find the behaviors to be problematic. The SESBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity.
Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)
The SESBI is a 38-item measure of disruptive behavior utilized across the PCIT literature. Teachers will rate the current frequency of child behavior problems on a 7-point Likert scale and determine whether or not they find the behaviors to be problematic. The SESBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity.
Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)
The DPICS-IV observational paradigm and coding system is the gold standard for assessing parent and child observational outcomes across the PCIT literature. During each 5-minute parent-child situation (child-led, parent-led, clean-up), parents are provided standardized instructions via a bug-in-the-ear across a one-way mirror or video. All families are provided with the same set of standard toys during the observation. Each observation will be video recorded and subsequently coded for child compliance to commands and parenting "do" and "don't" skills by student research assistants who will be trained to research reliability and blinded to the child intervention status and timepoint.
Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)
The DPICS-IV observational paradigm and coding system is the gold standard for assessing parent and child observational outcomes across the PCIT literature. During each 5-minute parent-child situation (child-led, parent-led, clean-up), parents are provided standardized instructions via a bug-in-the-ear across a one-way mirror or video. All families are provided with the same set of standard toys during the observation. Each observation will be video recorded and subsequently coded for child compliance to commands and parenting "do" and "don't" skills by student research assistants who will be trained to research reliability and blinded to the child intervention status and timepoint.
Change in Parenting Practices as assessed by Parenting Scale (PS)
Parents will complete the PS, which has been consistently used across the PCIT literature as a measure of parenting practices. The PS is a 30-item measure, which yields a Total score representing an average of responses on all items, and individual scale scores for Laxness, Over-reactivity, and Negativity. A higher score on the scale scores and on the Total score indicates a greater level of reported problematic parenting discipline style.
Change in Parenting Practices as assessed by Parenting Scale (PS)
Parents will complete the PS, which has been consistently used across the PCIT literature as a measure of parenting practices. The PS is a 30-item measure, which yields a Total score representing an average of responses on all items, and individual scale scores for Laxness, Over-reactivity, and Negativity. A higher score on the scale scores and on the Total score indicates a greater level of reported problematic parenting discipline style.
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
Parents and teachers will complete the BASC-3, a broadband assessment that includes disruptive behavior domains including hyperactivity, aggression, and attention problems, in addition to a general externalizing behavior problems composite. The BASC-3 has excellent reliability and validity and has been utilized extensively across the ASD literature and in examinations of PCIT with ASD samples. The Preschool versions will be used for children 2 to 5 years old, and the Child version will be used for children 6:0+.
Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
Parents and teachers will complete the BASC-3, a broadband assessment that includes disruptive behavior domains including hyperactivity, aggression, and attention problems, in addition to a general externalizing behavior problems composite. The BASC-3 has excellent reliability and validity and has been utilized extensively across the ASD literature and in examinations of PCIT with ASD samples. The Preschool versions will be used for children 2 to 5 years old, and the Child version will be used for children 6:0+.
Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
As a measure of disruptive behavior and symptoms of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD), parents and teachers will complete the DBD. The DBD contains 45items on a 4-point frequency scale. The DBD has been utilized in samples of preschoolers with ADHD and ODD, and in studies examining ADHD symptoms in samples of children with ASD.
Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
The DBD is a 45-item measure of disruptive behavior and symptoms of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) that has been utilized in samples of preschoolers with ADHD and ODD, and in studies examining ADHD symptoms in samples of children with ASD. Parents and teachers will complete the DBD, rating each item on a four-point scale ranging from not at all (0) to very much (3).

Secondary Outcome Measures

Parent Satisfaction with Tele-PCIT as assessed by Therapy Attitude Inventory (TAI)
To assess treatment satisfaction, parents will complete the TAI, which is widely used in PCIT studies. Several questions will be added to the TAI to address parental satisfaction and openness regarding the telehealth delivery format for families in the Tele-PCIT condition. The TAI uses a Likert-type satisfaction scale and scores will be reported via descriptive statistics with 95% CIs within categories.
Impact of Barriers on Treatment Engagement as assessed by Barriers to Treatment Participation Scale (BTPS)
Parents in Tele-PCIT will complete the BTPS at post-treatment to assess for the impact of barriers on treatment engagement throughout the intervention. The BTPS is a 44 item rating of how much parents agree with statements about their expectancies of barriers to treatment participation for their child, using a 5-point Likert scale (1=totally disagree, 5= totally agree). This measure has been used in other PCIT studies comparing engagement between clinic and telehealth delivery.

Full Information

First Posted
September 15, 2021
Last Updated
February 17, 2023
Sponsor
Medical University of South Carolina
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT05056922
Brief Title
Telehealth Rapid Intervention for Externalizing Behaviors in ASD
Acronym
THRIVE-ASD
Official Title
THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Health Resources and Services Administration (HRSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Disruptive Behavior, Externalizing Behavior, Parent-Child Interaction Therapy, Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Research assistant coders will be blind to treatment condition
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-PCIT (Parent-Child Interaction Therapy)
Arm Type
Experimental
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tele-PCIT
Intervention Description
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
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
Description
The ECBI is a 36-item measure of disruptive behavior problems utilized across the PCIT literature. Parents will rate the frequency of child behaviors on a 7-point Likert scale. The ECBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity. The cut-off for clinical significance is a raw score of 130.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
Description
The ECBI is a 36-item measure of disruptive behavior problems utilized across the PCIT literature. Parents will rate the frequency of child behaviors on a 7-point Likert scale. The ECBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity. The cut-off for clinical significance is a raw score of 130.
Time Frame
Pre-treatment to follow-up (~24 weeks)
Title
Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)
Description
The SESBI is a 38-item measure of disruptive behavior utilized across the PCIT literature. Teachers will rate the current frequency of child behavior problems on a 7-point Likert scale and determine whether or not they find the behaviors to be problematic. The SESBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Child Behavior Problems as assessed by Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R)
Description
The SESBI is a 38-item measure of disruptive behavior utilized across the PCIT literature. Teachers will rate the current frequency of child behavior problems on a 7-point Likert scale and determine whether or not they find the behaviors to be problematic. The SESBI yields a total raw score for intensity of behaviors and a normed T-score with higher scores indicating higher behavior problem severity.
Time Frame
Pre-treatment to follow-up (~24 weeks)
Title
Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)
Description
The DPICS-IV observational paradigm and coding system is the gold standard for assessing parent and child observational outcomes across the PCIT literature. During each 5-minute parent-child situation (child-led, parent-led, clean-up), parents are provided standardized instructions via a bug-in-the-ear across a one-way mirror or video. All families are provided with the same set of standard toys during the observation. Each observation will be video recorded and subsequently coded for child compliance to commands and parenting "do" and "don't" skills by student research assistants who will be trained to research reliability and blinded to the child intervention status and timepoint.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Child Compliance and Parent Interaction as assessed by Dyadic Parent-Child Interaction Coding System, 4th edition (DPICS-IV)
Description
The DPICS-IV observational paradigm and coding system is the gold standard for assessing parent and child observational outcomes across the PCIT literature. During each 5-minute parent-child situation (child-led, parent-led, clean-up), parents are provided standardized instructions via a bug-in-the-ear across a one-way mirror or video. All families are provided with the same set of standard toys during the observation. Each observation will be video recorded and subsequently coded for child compliance to commands and parenting "do" and "don't" skills by student research assistants who will be trained to research reliability and blinded to the child intervention status and timepoint.
Time Frame
Pre-treatment to follow-up (~24 weeks)
Title
Change in Parenting Practices as assessed by Parenting Scale (PS)
Description
Parents will complete the PS, which has been consistently used across the PCIT literature as a measure of parenting practices. The PS is a 30-item measure, which yields a Total score representing an average of responses on all items, and individual scale scores for Laxness, Over-reactivity, and Negativity. A higher score on the scale scores and on the Total score indicates a greater level of reported problematic parenting discipline style.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Parenting Practices as assessed by Parenting Scale (PS)
Description
Parents will complete the PS, which has been consistently used across the PCIT literature as a measure of parenting practices. The PS is a 30-item measure, which yields a Total score representing an average of responses on all items, and individual scale scores for Laxness, Over-reactivity, and Negativity. A higher score on the scale scores and on the Total score indicates a greater level of reported problematic parenting discipline style.
Time Frame
Pre-treatment to follow-up (~24 weeks)
Title
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
Description
Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
Description
Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Time Frame
Pre-treatment to follow-up (~24 weeks)
Title
Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
Description
Parents and teachers will complete the BASC-3, a broadband assessment that includes disruptive behavior domains including hyperactivity, aggression, and attention problems, in addition to a general externalizing behavior problems composite. The BASC-3 has excellent reliability and validity and has been utilized extensively across the ASD literature and in examinations of PCIT with ASD samples. The Preschool versions will be used for children 2 to 5 years old, and the Child version will be used for children 6:0+.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
Description
Parents and teachers will complete the BASC-3, a broadband assessment that includes disruptive behavior domains including hyperactivity, aggression, and attention problems, in addition to a general externalizing behavior problems composite. The BASC-3 has excellent reliability and validity and has been utilized extensively across the ASD literature and in examinations of PCIT with ASD samples. The Preschool versions will be used for children 2 to 5 years old, and the Child version will be used for children 6:0+.
Time Frame
Pre-treatment to follow-up (~24 weeks)
Title
Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
Description
As a measure of disruptive behavior and symptoms of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD), parents and teachers will complete the DBD. The DBD contains 45items on a 4-point frequency scale. The DBD has been utilized in samples of preschoolers with ADHD and ODD, and in studies examining ADHD symptoms in samples of children with ASD.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
Description
The DBD is a 45-item measure of disruptive behavior and symptoms of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) that has been utilized in samples of preschoolers with ADHD and ODD, and in studies examining ADHD symptoms in samples of children with ASD. Parents and teachers will complete the DBD, rating each item on a four-point scale ranging from not at all (0) to very much (3).
Time Frame
Pre-treatment to follow-up (~24 weeks)
Secondary Outcome Measure Information:
Title
Parent Satisfaction with Tele-PCIT as assessed by Therapy Attitude Inventory (TAI)
Description
To assess treatment satisfaction, parents will complete the TAI, which is widely used in PCIT studies. Several questions will be added to the TAI to address parental satisfaction and openness regarding the telehealth delivery format for families in the Tele-PCIT condition. The TAI uses a Likert-type satisfaction scale and scores will be reported via descriptive statistics with 95% CIs within categories.
Time Frame
Pre-treatment to post-treatment (~12 weeks)
Title
Impact of Barriers on Treatment Engagement as assessed by Barriers to Treatment Participation Scale (BTPS)
Description
Parents in Tele-PCIT will complete the BTPS at post-treatment to assess for the impact of barriers on treatment engagement throughout the intervention. The BTPS is a 44 item rating of how much parents agree with statements about their expectancies of barriers to treatment participation for their child, using a 5-point Likert scale (1=totally disagree, 5= totally agree). This measure has been used in other PCIT studies comparing engagement between clinic and telehealth delivery.
Time Frame
Pre-treatment to post-treatment (~12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Telehealth Rapid Intervention for Externalizing Behaviors in ASD

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