A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Psychopathology
- Sponsor
- Tulane University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change from baseline maternal depressive symptoms at post-intervention
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.
Detailed Description
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vMP targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. Eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. Outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (Respiratory Sinus Arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. Assessments will occur at intake, post, and 6 months following the group.
Investigators
Sarah Gray
Associate Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator
Tulane University
Eligibility Criteria
Inclusion Criteria
- •Enrollment status in one of the following services: Supplemental Nutrition Assistance Program (SNAP), Family Independence Temporary Assistance Program (FITAP), Medicaid, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), or Head Start
- •Maternal age of at least 18 years
- •Mother is primary caregiver of child
- •Mother speaks English
- •Child age is between 3-5 years
- •Family resides within 8 parish New Orleans metro area
Exclusion Criteria
- •Mother is not biological mother
- •Diagnosis of a heart condition in the mother or the child
- •Presence of a pacemaker in the mother or the child
- •Child diagnosis of autism or global developmental delay
- •Active maternal substance use
- •Active maternal psychosis
Outcomes
Primary Outcomes
Change from baseline maternal depressive symptoms at post-intervention
Time Frame: At completion of intervention, approximately 3 months
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline at post-intervention will be assessed. Higher scores reflect more depressive symptoms.
Change from baseline child behavior at post-intervention
Time Frame: At completion of intervention, approximately 3 months
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
Change from baseline maternal depressive symptoms at 6 month follow up
Time Frame: 6 months (follow up)
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more depressive symptoms.
Change from baseline maternal posttraumatic stress symptoms at post-intervention
Time Frame: At completion of intervention, approximately 3 months
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 3 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Change from baseline maternal posttraumatic stress symptoms at 6 month follow up
Time Frame: 6 months (follow up)
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Change from baseline child behavior at 6 month follow up.
Time Frame: 6 months (follow up)
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
Secondary Outcomes
- Change in parenting stress from baseline to 6 month follow up(6 months)
- Change in parenting stress from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in self-report parent child relationship from baseline to follow up(6 months)
- Change in maternal social support from baseline to post intervention(At completion of intervention, approximately 3 months)
- Change in Working Models from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal emotion regulation from baseline to follow up(6 months)
- Change in self-report parent child relationship from baseline to post intervention(At completion of intervention, approximately 3 months)
- Change in observed parenting sensitivity from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal social support from baseline to follow up(6 months)
- Change in maternal emotion regulation from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal emotion regulation while parenting from baseline to post intervention(At completion of intervention, approximately 3 months)
- Change in maternal emotion regulation while parenting from baseline to follow up(6 months)
- Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention(At completion of intervention, approximately 3 months)