Clinical trial NCT05474534: An Intervention to Enhance Well-Being in Trauma Exposed New Mothers
Official title: Beyond the Baby Blues: A Pilot Intervention to Enhance Well-Being in Trauma Exposed New Mothers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Dissociation
Maternal Care Patterns
Infant Behavior
Maternal Behavior
Maternal Distress
Mood Disturbance
Emotional Regulation
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups: 1) the Treatment group (participants in this group will receive the three-month neurofeedback intervention), or the Wait-list Control Group (participants in this group will not receive the neurofeedback intervention during the data collection period; they will be given the choice to use neurofeedback for after the data collection period has ended).
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change from Baseline Maternal PTSD Symptoms at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Maternal Dissociative Symptoms at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Maternal Symptoms of Parenting Stress at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Parental Sense of Competency and Self-Efficacy at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Maternal Risk of Child Abuse at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Maternal Depressive Symptoms at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Maternal Anger Control at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Weekly Changes of Maternal Emotional and Behavioral Self-Regulation Across 12 Weeks
timeFrame: Weekly, throughout the course of the 3-month intervention (across 12 weeks)
measure: Weekly Changes of Maternal Positive Affect and Well-Being Across 12 Weeks
timeFrame: Weekly, throughout the course of the 3-month intervention (across 12 weeks)
measure: Change from Baseline Infant Crying and Fussing Patterns at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
measure: Change from Baseline Infant Psychosocial Well-Being at 3 Months
timeFrame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University School of Social Work
state: Michigan
Study officials:
References: