Recruiting

PCIT

Sponsor:

University of Florida

Code:

NCT06827951

Conditions

Autonomic Dysregulation

Anxiety

Depression

Parent-Child Relations

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Parent-Child Interaction Therapy (PCIT)

Study Details

Brief 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.
  • 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

Conditions

Autonomic Dysregulation

Anxiety

Depression

Parent-Child Relations

Study ID

NCT06827951

Start date

Feb 14, 2025

Status verified date

Aug, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

PCIT Group

All participants will complete the five online surveys and provide two saliva samples.

Interventions

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.

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 ]
  • Assessing the Impact of Adversity History [ Time Frame: Up to 1 week ]
  • Measuring change in oxytocin Levels [ Time Frame: Up to 4 weeks ]
  • Measuring change in parental stress using the parental stress scale [ Time Frame: 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 ]
  • Measuring change in child behavior using the parent-report Eyberg Child Behavior Inventory [ Time Frame: 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 ]
  • Measuring change in depression using the Patient Health Questionnaire-8 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Britney Duner, LCSW

(904) 383-1038Britney.Duner@jax.ufl.edu

Kourtney Schroeder, PsyD

(904) 383-1038Kourtney.Schroeder@jax.ufl.edu

Locations

UF Health Child Psychiatry

Recruiting

Gainesville, Florida, United States, 32606

Contacts

Liliana L. Acosta, PhD

352-294-4900lilianalacosta@ufl.edu

Principal Investigator:

Liliana L Acosta, PhD

UF Health Psychiatry San Jose

Recruiting

Jacksonville, Florida, United States, 32217

Contacts

Britney Duner, LCSW

904-383-1038Britney.Duner@jax.ufl.edu

Kourtney Schroeder, PsyD

9043831038Kourtney.Schroeder@jax.ufl.edu

Principal Investigator:

Britney Duner, LCSW

More Information

Sponsor

University of Florida

Last update posted

Feb 12, 2026

Last verified

Aug, 2025

Keywords

  • Polyvagal Theory
  • Adversity
  • Parent-Child Interaction Therapy
  • Attachment
  • Autonomic Reactivity
  • Oxytocin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.