Autonomic DysregulationNCT06827951
Potential Benefits of Parent Child Interaction Therapy (PCIT)
An observational study of Autonomic Dysregulation and Anxiety, run by University of Florida at 2 sites in United States.
Trial summary
The goal of this study is to explore possible benefits of Parent-Child Interaction Therapy (PCIT). The main goals of the study are: To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Dysregulation, Anxiety, Depression
- What is being tested?
- Parent-Child Interaction Therapy (PCIT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2025to 1 Jun 2026
- Phase
- Observational
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators intend to recruit parents of children aged 2-7 with behavioral issues who are eligible for the PCIT program at two university clinics (UF Health Jacksonville and Shands Gainesville) specializing in child psychology and parent training. This population represents those most likely to experience stress and benefit from improved parent-child interactions and stress regulation
Who may be able to join
- Parents of children aged 2-7 years old who are eligible for Parent-Child Interaction Therapy (PCIT) based on behavioral concerns.
- The primary caregiver of the child and be actively involved in the child's daily care.
- Willing to attend all PCIT sessions and complete pre-, mid- and post-intervention assessments.
- Fluent in English to ensure comprehension of the intervention and assessment materials.
Who cannot join
- Parents with diagnosed severe mental health disorders (e.g., schizophrenia, bipolar disorder) that may interfere with participation in PCIT.
- Children with conditions that require interventions other than PCIT (e.g., severe developmental disabilities).
- Parents who have previously participated in PCIT are excluded to avoid confounding results.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UF Health Child Psychiatry
Gainesville, Florida, 32606
Liliana L. Acosta, PhD, 352-294-4900, lilianalacosta@ufl.edu
Liliana L Acosta, PhD
- Recruiting
UF Health Psychiatry San Jose
Jacksonville, Florida, 32217
Britney Duner, LCSW, 904-383-1038, Britney.Duner@jax.ufl.edu
Kourtney Schroeder, PsyD, 9043831038, Kourtney.Schroeder@jax.ufl.edu
About this study
Official title: A Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)
The goal of this study is to explore possible benefits of Parent-Child Interaction Therapy (PCIT). The main goals of the study are:
- To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants.
- To examine the effects of PCIT To identify individual characteristics that influence the effects of PCIT.
Participants will:
- complete 5 online surveys (1x pre-PCIT, 3x during PCIT, and 1x post-PCIT)
- complete the PCIT program
Read the detailed description
It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which PCIT can influence self-reported stress and autonomic and neuroendocrine functioning in parents. This will be accomplished by our team by using well-validated self-report measures of mental health, autonomic reactivity, parental stress and attachment, and non-invasive measurements of levels of oxytocin.
Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity and the neuropeptides oxytocin relate to the overall functioning of the participants.
- The investigators will examine how measures of autonomic reactivity and levels of oxytocin relate to prior mental/medical health.
- Hypothesis: Participants with lower levels of oxytocin and/or increased autonomic reactivity will report being more impacted by their prior adversity and having more emotional/physical symptoms.
Specific Aim 2: To investigate the impact of PCIT
- The investigators will explore whether PCIT leads to improvements in parental stress, parent-child attachment, and parental neuroendocrine functioning.
- Hypothesis: Parents will show a significant decrease in perceived stress and improvement in emotional wellbeing oxytocin levels following CDI. They will also show a decrease in perceived stress, and improvement in attachment and emotional wellbeing following the entire PCIT intervention.
Specific Aim 3: To identify individual characteristics that influence the effectiveness of PCIT.
- The investigators will explore the impact of specific vulnerability and resiliency factors (e.g., stress, prior adversity) on how well parents benefit from PCIT
- Hypothesis: Parental stress and prior mental/medical adversity will negatively impact the effectiveness of intervention
- Conditions
- Autonomic Dysregulation, Anxiety, Depression, Parent-Child Relations
- Being tested
- Parent-Child Interaction Therapy (PCIT)
- Keywords
- Polyvagal Theory, Adversity, Parent-Child Interaction Therapy, Attachment, Autonomic Reactivity, Oxytocin
- Medical subject headings
- Primary Dysautonomias, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction Therapy (PCIT)Behavioural
Participants will undergo the standard PCIT program, which consists of two phases: Child-Directed Interaction (CDI) and Parent-Directed Interaction (PDI).
- CDI Phase: Parents will learn and practice techniques that focus on strengthening the parent-child relationship through play and positive reinforcement.
- PDI Phase: Parents will be coached in effective discipline strategies to manage their child's behavioral problems.
| Study group | Role | What they receive |
|---|---|---|
| PCIT Group | All participants will complete the five online surveys and provide two saliva samples. Receives: Behavioral: Parent-Child Interaction Therapy (PCIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form
This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity
Measured: Through study completion, an average of 20 weeks
Assessing the Impact of Adversity History
This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores.
Measured: Up to 1 week
Measuring change in oxytocin Levels
Oxytocin levels will be assessed using salivary samples. Increased salivary oxytocin indicates improvement.
Measured: Up to 4 weeks
Measuring change in parental stress using the parental stress scale
This 18-item questionnaire assesses parents' feelings about their parenting role via a 5-point Likert scale (Strongly disagree = 1 to Strongly agree = 5). Lower scores indicate lower levels of parental stress.
Measured: Through study completion, an average of 20 weeks
Measuring change in parental attachment using the Child-Parent Relationship Scale
This 30-item questionnaire assesses parents' views of their relationship with their child via a 5-point Likert scale (1 = definitely does not apply to 5 = definitively applies). The scores for the subscales (e.g., closeness, conflict, dependency) are calculated by summing the relevant items, with higher scores indicating more positive views of the relationship.
Measured: Through study completion, an average of 20 weeks
Measuring change in child behavior using the parent-report Eyberg Child Behavior Inventory
This 36-item measure assesses the frequency and severity of disruptive behaviors, as well as the extent to which parents find the behaviors troublesome via a 7-point Likert scale (1 Never Occurs to 7 = Always Occurs) and a binary Problem scale. Total Intensity Scale scores range from 36 to 352, with clinical cut-off scores of 131-133.
Measured: Through study completion, an average of 20 weeks
Measuring change in anxiety using the General Anxiety Disorder-7
This 7-item measure assesses anxiety via a 4-point Likert scale (0 = Not at all to 3 = Nearly every day) with higher scores reflecting more symptoms of anxiety.
Measured: Through study completion, an average of 20 weeks
Measuring change in depression using the Patient Health Questionnaire-8
This 8-item measure assesses depression via a 4-point Likert scale (0 = Not at all to 3 = Nearly every day) with higher scores reflecting more symptoms of depression.
Measured: Through study completion, an average of 20 weeks
Measuring change in post-traumatic stress symptoms using the PTSD Checklist for DSM-5
This 20-item measure assesses PTSD symptoms via a 5-point Likert (0 = Not at all to 4 = Extremely) with higher scores reflecting more symptoms of PTSD.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start14 Feb 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysregulationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britney N. Duner, LCSW, Principal investigator, University of Florida College of Medicine JacksonvilleLiliana L. Acosta, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827951
- Sponsor's protocol ID
- IRB202400867
- Status last verified
- Aug 2025
- First submitted
- 18 Nov 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)
- ClinicalTrials.gov ID
- NCT06827951
- Acronym / sponsor ID
- IRB202400867
- Conditions
- Autonomic Dysregulation, Anxiety, Depression, Parent-Child Relations
- Keywords
- Polyvagal Theory, Adversity, Parent-Child Interaction Therapy, Attachment, Autonomic Reactivity, Oxytocin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 Feb 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 goal of this study is to explore possible benefits of Parent-Child Interaction Therapy (PCIT). The main goals of the study are:
- To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants.
- To examine the effects of PCIT To identify individual characteristics that influence the effects of PCIT.
Participants will:
- complete 5 online surveys (1x pre-PCIT, 3x during PCIT, and 1x post-PCIT)
- complete the PCIT program
Detailed description
It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which PCIT can influence self-reported stress and autonomic and neuroendocrine functioning in parents. This will be accomplished by our team by using well-validated self-report measures of mental health, autonomic reactivity, parental stress and attachment, and non-invasive measurements of levels of oxytocin.
Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity and the neuropeptides oxytocin relate to the overall functioning of the participants.
- The investigators will examine how measures of autonomic reactivity and levels of oxytocin relate to prior mental/medical health.
- Hypothesis: Participants with lower levels of oxytocin and/or increased autonomic reactivity will report being more impacted by their prior adversity and having more emotional/physical symptoms.
Specific Aim 2: To investigate the impact of PCIT
- The investigators will explore whether PCIT leads to improvements in parental stress, parent-child attachment, and parental neuroendocrine functioning.
- Hypothesis: Parents will show a significant decrease in perceived stress and improvement in emotional wellbeing oxytocin levels following CDI. They will also show a decrease in perceived stress, and improvement in attachment and emotional wellbeing following the entire PCIT intervention.
Specific Aim 3: To identify individual characteristics that influence the effectiveness of PCIT.
- The investigators will explore the impact of specific vulnerability and resiliency factors (e.g., stress, prior adversity) on how well parents benefit from PCIT
- Hypothesis: Parental stress and prior mental/medical adversity will negatively impact the effectiveness of intervention
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCIT Group | – | Behavioral: Parent-Child Interaction Therapy (PCIT)All participants will complete the five online surveys and provide two saliva samples. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators intend to recruit parents of children aged 2-7 with behavioral issues who are eligible for the PCIT program at two university clinics (UF Health Jacksonville and Shands Gainesville) specializing in child psychology and parent training. This population represents those most likely to experience stress and benefit from improved parent-child interactions and stress regulation
Key inclusion criteria (4 listed)
- Parents of children aged 2-7 years old who are eligible for Parent-Child Interaction Therapy (PCIT) based on behavioral concerns.
- The primary caregiver of the child and be actively involved in the child's daily care.
- Willing to attend all PCIT sessions and complete pre-, mid- and post-intervention assessments.
- Fluent in English to ensure comprehension of the intervention and assessment materials.
Key exclusion criteria (3 listed)
- Parents with diagnosed severe mental health disorders (e.g., schizophrenia, bipolar disorder) that may interfere with participation in PCIT.
- Children with conditions that require interventions other than PCIT (e.g., severe developmental disabilities).
- Parents who have previously participated in PCIT are excluded to avoid confounding results.
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 |
|---|---|---|
| Parent-Child Interaction Therapy (PCIT)Participants will undergo the standard PCIT program, which consists of two phases: Child-Directed Interaction (CDI) and Parent-Directed Interaction (PDI). * CDI Phase: Parents will learn and practice techniques that focus on strengthening the parent-child relationship through play and positive reinforcement. * PDI Phase: Parents will be coached in effective discipline strategies to manage their child's behavioral problems. | Behavioural | PCIT Group |
Primary outcome
Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form
Time frame: Through study completion, an average of 20 weeks
This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity
Assessing the Impact of Adversity History
Time frame: Up to 1 week
This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores.
Measuring change in oxytocin Levels
Time frame: Up to 4 weeks
Oxytocin levels will be assessed using salivary samples. Increased salivary oxytocin indicates improvement.
Measuring change in parental stress using the parental stress scale
Time frame: Through study completion, an average of 20 weeks
This 18-item questionnaire assesses parents' feelings about their parenting role via a 5-point Likert scale (Strongly disagree = 1 to Strongly agree = 5). Lower scores indicate lower levels of parental stress.
Measuring change in parental attachment using the Child-Parent Relationship Scale
Time frame: Through study completion, an average of 20 weeks
This 30-item questionnaire assesses parents' views of their relationship with their child via a 5-point Likert scale (1 = definitely does not apply to 5 = definitively applies). The scores for the subscales (e.g., closeness, conflict, dependency) are calculated by summing the relevant items, with higher scores indicating more positive views of the relationship.
Measuring change in child behavior using the parent-report Eyberg Child Behavior Inventory
Time frame: Through study completion, an average of 20 weeks
This 36-item measure assesses the frequency and severity of disruptive behaviors, as well as the extent to which parents find the behaviors troublesome via a 7-point Likert scale (1 Never Occurs to 7 = Always Occurs) and a binary Problem scale. Total Intensity Scale scores range from 36 to 352, with clinical cut-off scores of 131-133.
Measuring change in anxiety using the General Anxiety Disorder-7
Time frame: Through study completion, an average of 20 weeks
This 7-item measure assesses anxiety via a 4-point Likert scale (0 = Not at all to 3 = Nearly every day) with higher scores reflecting more symptoms of anxiety.
Measuring change in depression using the Patient Health Questionnaire-8
Time frame: Through study completion, an average of 20 weeks
This 8-item measure assesses depression via a 4-point Likert scale (0 = Not at all to 3 = Nearly every day) with higher scores reflecting more symptoms of depression.
Measuring change in post-traumatic stress symptoms using the PTSD Checklist for DSM-5
Time frame: Up to 1 week
This 20-item measure assesses PTSD symptoms via a 5-point Likert (0 = Not at all to 4 = Extremely) with higher scores reflecting more symptoms of PTSD.
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 12 Feb 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.
Britney N. Duner, LCSW principal investigator
University of Florida College of Medicine Jacksonville
Liliana L. Acosta, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Dysregulation and Anxiety, run by University of Florida at 2 sites 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 4 inclusion and 3 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Britney Duner, LCSW ((904) 383-1038, Britney.Duner@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form (time frame: Through study completion, an average of 20 weeks). The study lists 9 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 12 Feb 2026.