Beyond the Baby Blues: A Pilot Intervention to Enhance Well-Being in Trauma Exposed New Mothers

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. The investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. The investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
Wayne State University School of Social Work
RECRUITING
Detroit
Contact Information
Primary
Lisa S Panisch, PhD
Lisa.panisch@wayne.edu
313-577-4409
Time Frame
Start Date: 2023-02-13
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Experimental: Treatment Group
Mothers in the treatment group will complete pre- and post-treatment self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in the treatment group will be provided with a wearable neurofeedback device called the MUSE 2, to use at home for 4-6 10-minute sessions per week, over the course of 3 months. Mothers in the treatment group will complete weekly virtual surveys assessing emotional and behavioral self-regulation capacities (e.g., anger control, etc.) throughout the 3 month duration of this study phase. Mothers in the treatment group will also answer additional weekly questions about intervention uptake (i.e., no. of sessions completed in the past week) and feasibility (i.e.,barriers to treatment uptake, ease of use of the device, etc.).
No_intervention: Wait-list Control Group
Mothers in the wait-list control group will complete pre- and post-treatment self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in the wait-list control group will complete weekly virtual surveys assessing emotional and behavioral self-regulation capacities (e.g., anger control, etc.) throughout the 3 month duration of this study phase.
Related Therapeutic Areas
Sponsors
Leads: Wayne State University

This content was sourced from clinicaltrials.gov