An Intervention to Enhance Well-Being in Trauma Exposed New Mothers

Launched by WAYNE STATE UNIVERSITY · Jul 22, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help mothers who have experienced trauma and are dealing with symptoms of post-traumatic stress disorder (PTSD). The study will test a mobile neurofeedback program, which is a type of therapy that uses technology to help improve mental well-being. The goal is to see if this program can reduce trauma symptoms and parenting stress, while also improving how mothers interact with their infants and how their babies develop emotionally and behaviorally. Researchers believe that mothers using this program will feel better overall and have more positive experiences with parenting compared to those who do not participate in the program.

To be eligible for this study, mothers need to have experienced childhood trauma and show signs of PTSD. They should also have a baby aged between 3 to 9 months and have a smartphone or tablet that works with the neurofeedback device. Participants can expect to take part in sessions using this technology, and researchers will monitor changes in both the mothers' mental health and their babies' behavior. It's important to note that mothers with certain mental health conditions or unsafe living situations will not be able to join the study. This trial is currently recruiting participants, and it offers a chance for mothers to improve their well-being and parenting skills while helping researchers learn more about effective treatments for PTSD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The inclusion criteria for mothers will be 1) a score of 2+ on the Adverse Childhood Experiences measure for childhood trauma exposure; 2) a score of 3+ on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure for PTSD symptoms OR endorsement of 2 or more past-month symptoms of moderate or greater severity on the depersonalization/derealization subscale of the Dissociative Subtype of PTSD Scale (DSPS); 3) having a child who is between the ages of 3-9 months old; 3) having a personal phone or tablet device that is compatible with the MUSE 2 neurofeedback device.
• Exclusion Criteria:
• • Mothers and their infants will be excluded if mothers 1) have a lifetime history of significant untreated mental illness, neurological or pervasive developmental disorders; 2) have a documented history of epilepsy; 3) ever experienced previous head injury with loss of consciousness; 4) are currently experiencing intimate partner violence or otherwise state that their current living conditions are unsafe; 5) are currently experiencing psychosis or have been suicidal within the last six months; 6) are currently taking, or in the past month have taken benzodiazepines, narcotic drugs, or cannabis; 7) have engaged in self-harming behaviors in the last 3 months requiring medical attention; 8) are pregnant; 9) are current students at Wayne State University or have plans to enroll as a student at Wayne State University anytime in the next 12 months; 10) do not have competence to understand or consent/assent to the study procedures; or 11) do not have fluency in written and spoken English.