Autism Spectrum DisorderTHRIVE-ASDNCT05056922
Telehealth Rapid Intervention for Externalizing Behaviors in ASD
A study testing Tele-PCIT and Treatment as Usual in people with Autism Spectrum Disorder and Disruptive Behavior, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Disruptive Behavior, Externalizing Behavior
- What is being tested?
- Tele-PCIT and Treatment as Usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD
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
- Being tested
- Tele-PCIT, Treatment as Usual
- Medical subject headings
- Autism Spectrum Disorder, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-PCITBehavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-PCIT (Parent-Child Interaction Therapy) | Experimental | Not described Receives: Behavioral: Tele-PCIT |
| Treatment as Usual | Active comparator | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
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.
Measured: Pre-treatment to follow-up (~24 weeks)
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Pre-treatment to follow-up (~24 weeks)
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
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.
Measured: Pre-treatment to follow-up (~24 weeks)
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
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.
Measured: Pre-treatment to follow-up (~24 weeks)
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+.
Measured: Pre-treatment to post-treatment (~12 weeks)
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+.
Measured: Pre-treatment to follow-up (~24 weeks)
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
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).
Measured: Pre-treatment to follow-up (~24 weeks)
Secondary outcomes (2)
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
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.
Measured: Pre-treatment to post-treatment (~12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start11 Feb 2022
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056922
- Sponsor's protocol ID
- 00114600
- Other IDs
- R41MC42775-01-00
- Acronym
- THRIVE-ASD
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD
- ClinicalTrials.gov ID
- NCT05056922
- Acronym / sponsor ID
- THRIVE-ASD / 00114600
- Conditions
- Autism Spectrum Disorder, Disruptive Behavior, Externalizing Behavior, Parent-Child Interaction Therapy, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-PCIT (Parent-Child Interaction Therapy) | Experimental | Behavioral: Tele-PCIT |
| Treatment as Usual | Active comparator | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 2 years to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-PCITFamilies 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. | Behavioural | Tele-PCIT (Parent-Child Interaction Therapy) |
| Treatment as UsualFamilies 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. | Behavioural | Treatment as Usual |
Primary outcome
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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)
Time frame: Pre-treatment to post-treatment (~12 weeks)
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)
Time frame: Pre-treatment to follow-up (~24 weeks)
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).
2 secondary outcomes
Parent Satisfaction with Tele-PCIT as assessed by Therapy Attitude Inventory (TAI)
Time frame: Pre-treatment to post-treatment (~12 weeks)
Impact of Barriers on Treatment Engagement as assessed by Barriers to Treatment Participation Scale (BTPS)
Time frame: Pre-treatment to post-treatment (~12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-PCIT and Treatment as Usual in people with Autism Spectrum Disorder and Disruptive Behavior, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI) (time frame: Pre-treatment to post-treatment (~12 weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.