Disruptive BehaviorNCT07225010
Tele-PCIT for Healthy Relationships in Families At-Risk
A study testing Telehealth Parent Child Interaction Therapy and Telehealth Parent Child Interaction Therapy (Delayed Start) in people with Disruptive Behavior and Pediatrics, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The study will examine Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) for young children at risk for adverse childhood experiences and/or trauma exposure. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Disruptive Behavior, Pediatrics
- What is being tested?
- Telehealth Parent Child Interaction Therapy and Telehealth Parent Child Interaction Therapy (Delayed Start)
- 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child participants must:
- Be between 2:0-6:11 years old
- Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory (ECBI)
- Have receptive language appropriate for PCIT (approximately 2-years old)
- Medicaid eligible, or be uninsured
- Score of 1 or greater on an ACEs (adverse childhood experiences) measure (PEARLS)
Show all 10Show fewer
- Parent participants must:
- Be the child's legal guardian
- Be able to provide consent for themselves (i.e., have decision making capacity and do not need a legally authorized representative themselves).
- Must be living with the child
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutledge Tower
Charleston, South Carolina, 29425
Rosmary Ros-Demarize, PhD, 843-714-1352, pcitfamilias@musc.edu
About this study
Official title: Fostering Healthy Relationships Through Tele-PCIT for Families of South Carolina
The study will examine Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) for young children at risk for adverse childhood experiences and/or trauma exposure.
Read the detailed description
This randomized controlled trial evaluates the feasibility, acceptability, engagement, and initial efficacy of time-limited Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) across 40 young children at risk for adverse childhood experiences and/or trauma exposure. The study compares outcomes between families receiving Tele-PCIT (n = 20) and those assigned to a waitlist control (n = 20). All families will complete baseline, post, and follow-up evaluations to assess child behavioral outcomes, parenting outcomes, and trauma symptoms. In order to be eligible children are between 2 and 7 years of age presenting with behavioral concerns and scoring at-risk on childhood averse events measures.
- Conditions
- Disruptive Behavior, Pediatrics
- Being tested
- Telehealth Parent Child Interaction Therapy, Telehealth Parent Child Interaction Therapy (Delayed Start)
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Parent Child Interaction TherapyBehavioural
Also called Tele-PCIT, iPCIT
During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset.
Telehealth Parent Child Interaction Therapy (Delayed Start)Behavioural
Also called Tele-PCIT, iPCIT
Delayed start of 12-weeks for delivery of Tele-PCIT. During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset.
| Study group | Role | What they receive |
|---|---|---|
| Tele-PCIT | Experimental | Families in the Tele-PCIT condition will recieve a time limited (10 session) version of PCIT via telehealth. Receives: Behavioral: Telehealth Parent Child Interaction Therapy |
| Waitlist Control | Other | Delayed Start of Tele-PCIT Receives: Behavioral: Telehealth Parent Child Interaction Therapy (Delayed Start) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Practices
Measured by the Parenting Scale. The parenting scale is comprised of 30 items rated 1-7 with specific items being averaged to create composites for Laxness, Verbosity, and Overreactivity. Higher scores on each scale indicate higher levels of each parenting behavior.
Measured: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Child Behavior
Measured by Eyberg Child Behavior Inventory. The ECBI is comprised of 36 items ranging from 1 to 7 and the overall score has a a minimum of 36 and maximum of 252 with higher scores indicating higher behavioral challenges.
Measured: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Trauma Related Symptoms
Measured by the Child and Adolescent Trauma Screen. The CATS contains 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, with a range of 0-48 and higher scores indicating greater symptoms.
Measured: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start12 Feb 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive BehaviorStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Principal investigator, Rosmary Ros-Demarize, Medical University of South Carolina
- Investigators
- Rosmary Ros-Demarize, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225010
- Sponsor's protocol ID
- Pro00146035
- Other IDs
- 2167-SP
- Status last verified
- Mar 2026
- First submitted
- 3 Nov 2025
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Healthy Relationships Through Tele-PCIT for Families of South Carolina
- ClinicalTrials.gov ID
- NCT07225010
- Acronym / sponsor ID
- Pro00146035
- Conditions
- Disruptive Behavior, Pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Nov 2025 (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 study will examine Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) for young children at risk for adverse childhood experiences and/or trauma exposure.
Detailed description
This randomized controlled trial evaluates the feasibility, acceptability, engagement, and initial efficacy of time-limited Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) across 40 young children at risk for adverse childhood experiences and/or trauma exposure. The study compares outcomes between families receiving Tele-PCIT (n = 20) and those assigned to a waitlist control (n = 20). All families will complete baseline, post, and follow-up evaluations to assess child behavioral outcomes, parenting outcomes, and trauma symptoms. In order to be eligible children are between 2 and 7 years of age presenting with behavioral concerns and scoring at-risk on childhood averse events measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-PCIT | Experimental | Behavioral: Telehealth Parent Child Interaction TherapyFamilies in the Tele-PCIT condition will recieve a time limited (10 session) version of PCIT via telehealth. |
| Waitlist Control | Other | Behavioral: Telehealth Parent Child Interaction Therapy (Delayed Start)Delayed Start of Tele-PCIT |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Child participants must:
- Parent participants must:
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Telehealth Parent Child Interaction TherapyAlso: Tele-PCIT, iPCITDuring tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset. | Behavioural | Tele-PCIT |
| Telehealth Parent Child Interaction Therapy (Delayed Start)Also: Tele-PCIT, iPCITDelayed start of 12-weeks for delivery of Tele-PCIT. During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset. | Behavioural | Waitlist Control |
Primary outcome
Parenting Practices
Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Measured by the Parenting Scale. The parenting scale is comprised of 30 items rated 1-7 with specific items being averaged to create composites for Laxness, Verbosity, and Overreactivity. Higher scores on each scale indicate higher levels of each parenting behavior.
Child Behavior
Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Measured by Eyberg Child Behavior Inventory. The ECBI is comprised of 36 items ranging from 1 to 7 and the overall score has a a minimum of 36 and maximum of 252 with higher scores indicating higher behavioral challenges.
Trauma Related Symptoms
Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Measured by the Child and Adolescent Trauma Screen. The CATS contains 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, with a range of 0-48 and higher scores indicating greater symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Rosmary Ros-Demarize, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Parent Child Interaction Therapy and Telehealth Parent Child Interaction Therapy (Delayed Start) in people with Disruptive Behavior and Pediatrics, 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 10 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Practices (time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up). The study lists 3 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 6 Mar 2026.