Potential Benefits of Parent Child Interaction Therapy (PCIT)

NCT ID: NCT06827951

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-14

Study Completion Date

2026-06-01

Brief Summary

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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

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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

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Autonomic Dysregulation Anxiety Depression Parent-Child Relations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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PCIT Group

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

Parent-Child Interaction Therapy (PCIT)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Britney N. Duner, LCSW

Role: PRINCIPAL_INVESTIGATOR

University of Florida College of Medicine Jacksonville

Liliana L. Acosta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health Child Psychiatry

Gainesville, Florida, United States

Site Status RECRUITING

UF Health Psychiatry San Jose

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Britney Duner, LCSW

Role: CONTACT

(904) 383-1038

Kourtney Schroeder, PsyD

Role: CONTACT

(904) 383-1038

Facility Contacts

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Liliana L. Acosta, PhD

Role: primary

352-294-4900

Britney Duner, LCSW

Role: primary

904-383-1038

Kourtney Schroeder, PsyD

Role: backup

9043831038

Other Identifiers

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IRB202400867

Identifier Type: -

Identifier Source: org_study_id

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