Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06827951
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potential Benefits of Parent Child Interaction Therapy (PCIT)
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
A Mixed-Methods Approach Utilizing Self-Report Scales and Oxytocin Levels to Determine the Potential Benefits of Parent Child Interaction Therapy (PCIT)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: