Potential Benefits of Parent Child Interaction Therapy (PCIT)

NCT06827951 | Recruiting

• 1 other identifier: IRB202400867
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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

  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.

  Up to 1 week

• Measuring change in oxytocin Levels

  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

  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

  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

  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

  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

  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

  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

Study Arms (1)

PCIT Group

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

Behavioral: Parent-Child Interaction Therapy (PCIT)

Interventions

Parent-Child Interaction Therapy (PCIT) 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.

PCIT Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF Health Child Psychiatry

Gainesville, Florida, 32606, United States

RECRUITING

UF Health Psychiatry San Jose

Jacksonville, Florida, 32217, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be collected at two timepoints (pre PCIT and during PCIT). Salivary samples will be used to measure oxytocin levels.

MeSH Terms

Conditions

Primary Dysautonomias; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Britney N. Duner, LCSW

  University of Florida College of Medicine Jacksonville

  PRINCIPAL INVESTIGATOR

• Liliana L. Acosta, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Britney Duner, LCSW

CONTACT

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

Kourtney Schroeder, PsyD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: February 14, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)