Clinical trial NCT06827951: Potential Benefits of Parent Child Interaction Therapy (PCIT)
Official title: A Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autonomic Dysregulation
Anxiety
Depression
Parent-Child Relations
Keywords: Polyvagal Theory
Adversity
Parent-Child Interaction Therapy
Attachment
Autonomic Reactivity
Oxytocin
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form
timeFrame: Through study completion, an average of 20 weeks
measure: Assessing the Impact of Adversity History
timeFrame: Up to 1 week
measure: Measuring change in oxytocin Levels
timeFrame: Up to 4 weeks
measure: Measuring change in parental stress using the parental stress scale
timeFrame: Through study completion, an average of 20 weeks
measure: Measuring change in parental attachment using the Child-Parent Relationship Scale
timeFrame: Through study completion, an average of 20 weeks
measure: Measuring change in child behavior using the parent-report Eyberg Child Behavior Inventory
timeFrame: Through study completion, an average of 20 weeks
measure: Measuring change in anxiety using the General Anxiety Disorder-7
timeFrame: Through study completion, an average of 20 weeks
measure: Measuring change in depression using the Patient Health Questionnaire-8
timeFrame: Through study completion, an average of 20 weeks
measure: Measuring change in post-traumatic stress symptoms using the PTSD Checklist for DSM-5
timeFrame: Up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Child Psychiatry
state: Florida
city: Jacksonville
country: United States
facility: UF Health Psychiatry San Jose
state: Florida
Study officials:
affiliation: University of Florida College of Medicine Jacksonville
name: Britney N. Duner, LCSW
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Melanie N. Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: