Potential Benefits of Parent Child Interaction Therapy (PCIT)

February 9, 2026 updated by: University of Florida

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32606
        • Recruiting
        • UF Health Child Psychiatry
        • Contact:
        • Principal Investigator:
          • Liliana L Acosta, PhD
      • Jacksonville, Florida, United States, 32217
        • Recruiting
        • UF Health Psychiatry San Jose
        • Contact:
        • Contact:
        • Principal Investigator:
          • Britney Duner, LCSW
        • Sub-Investigator:
          • Kourtney Schroeder, PsyD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCIT Group
All participants will complete the five online surveys and provide two saliva samples.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 20 weeks
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.
Up to 1 week
Measuring change in oxytocin Levels
Time Frame: Up to 4 weeks
Oxytocin levels will be assessed using salivary samples. Increased salivary oxytocin indicates improvement.
Up to 4 weeks
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.
Through study completion, an average of 20 weeks
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.
Through study completion, an average of 20 weeks
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.
Through study completion, an average of 20 weeks
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.
Through study completion, an average of 20 weeks
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.
Through study completion, an average of 20 weeks
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.
Up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Britney N. Duner, LCSW, University of Florida College of Medicine Jacksonville
  • Principal Investigator: Liliana L. Acosta, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202400867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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