Active — Not RecruitingNot Applicable

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

United States40 participantsStarted 2023-02-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 …

What they're measuring

Change from Baseline Maternal PTSD Symptoms at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Change from Baseline Maternal Dissociative Symptoms at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Change from Baseline Maternal Symptoms of Parenting Stress at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Change from Baseline Parental Sense of Competency and Self-Efficacy at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Change from Baseline Maternal Risk of Child Abuse at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Change from Baseline Maternal Depressive Symptoms at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Change from Baseline Maternal Anger Control at 3 Months

Timeframe: Baseline and Post-intervention Assessments (intervention lasts 3 months)

Trial details

NCT IDNCT05474534

SponsorWayne State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

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