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Recruiting NCT06827951

Potential Benefits of Parent Child Interaction Therapy (PCIT)

Observational Autonomic Dysregulation Anxiety Depression Parent-Child Relations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parent-Child Interaction Therapy (PCIT).
Who it may be relevant to
Registry conditions: Autonomic Dysregulation, Anxiety, Depression, Parent-Child Relations. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)

Overview

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

Interventions

  • Behavioral 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 measures

  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • UF Health Child Psychiatry — Gainesville
  • UF Health Psychiatry San Jose — Jacksonville

Identifiers

NCT: NCT06827951 · IRB202400867

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗