Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:50 PM
Ignite Modification Date: 2025-12-24 @ 11:50 PM
NCT ID: NCT06827951
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
Study: NCT06827951
Study Brief:
Protocol Section: NCT06827951