Recruiting

Oxytocin Levels and Parent Child Interaction Therapy for Parental Stress and Attachment

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What is being collected

Data Collection

No DNA Sample
Who is being recruted

Anxiety Disorders+5

+ Autonomic Nervous System Diseases

+ Behavior

From 18 to 89 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2025
See protocol details

Summary

Principal SponsorUniversity of Florida
Study ContactBritney Duner, LCSWMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 14, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the potential benefits of Parent Child Interaction Therapy (PCIT) on self-reported stress and autonomic and neuroendocrine functioning in parents. It focuses on parents who have experienced various types of traumatic experiences, such as childhood adversity, maltreatment, and health situations. The research team uses well-validated self-report measures of mental health, autonomic reactivity, parental stress, attachment, and non-invasive measurements of levels of oxytocin to accomplish their goals. The study's importance lies in understanding how PCIT can help parents better manage stress and improve their relationships with their children. Throughout the study, participants will complete self-report questionnaires and provide salivary samples for oxytocin level assessment. The questionnaires measure various aspects, including the impact of adversity history, anxiety, autonomic reactivity, child behavior, depression, parental attachment, parental stress, and post-traumatic stress symptoms. By examining these measures before and after PCIT, the study will evaluate the therapy's effectiveness in improving parental stress, parent-child attachment, and parental neuroendocrine functioning. The study also investigates individual characteristics that may influence the effectiveness of PCIT, such as stress and prior adversity.

Official TitleA Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)
NCT06827951
Principal SponsorUniversity of Florida
Study ContactBritney Duner, LCSWMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersAutonomic Nervous System DiseasesBehaviorMental DisordersBehavioral SymptomsDepressionNervous System DiseasesPrimary Dysautonomias

Criteria

4 inclusion criteria required to participate
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.

3 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

UF Health Child Psychiatry

Gainesville, United StatesOpen UF Health Child Psychiatry in Google Maps
Recruiting

UF Health Psychiatry San Jose

Jacksonville, United States
Recruiting
2 Study Centers