Clinical trial NCT05129397: Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC)
Official title: A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychopathology
Keywords: biobehavioral regulation
Respiratory Sinus Arrhythmia
parenting behavior
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-11-22
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two arms: an experimental group receiving the Mom Power group intervention over 10 weeks, and a control group that will receive informational virtual mailings over 10 weeks. Treatment delivery will be consistent with the Mom Power manual and informational mailings will contain content from the Mom Power Curriculum.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline maternal depressive symptoms at post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change from baseline maternal depressive symptoms at 6 month follow up
timeFrame: 6 months (follow up)
measure: Change from baseline maternal posttraumatic stress symptoms at post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change from baseline maternal posttraumatic stress symptoms at 6 month follow up
timeFrame: 6 months (follow up)
measure: Change from baseline child behavior at post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change from baseline child behavior at 6 month follow up.
timeFrame: 6 months (follow up)
Secondary outcomes:
measure: Change in parenting stress from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in parenting stress from baseline to 6 month follow up
timeFrame: 6 months
measure: Change in self-report parent child relationship from baseline to post intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in self-report parent child relationship from baseline to follow up
timeFrame: 6 months
measure: Change in maternal social support from baseline to post intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in maternal social support from baseline to follow up
timeFrame: 6 months
measure: Change in observed parenting sensitivity from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in Working Models from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in maternal emotion regulation from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in maternal emotion regulation from baseline to follow up
timeFrame: 6 months
measure: Change in maternal emotion regulation while parenting from baseline to post intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in maternal emotion regulation while parenting from baseline to follow up
timeFrame: 6 months
measure: Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
measure: Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention
timeFrame: At completion of intervention, approximately 3 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane Child and Family Lab
state: Louisiana
Study officials:
affiliation: Tulane University
name: Sarah A Gray, PhD
role: PRINCIPAL_INVESTIGATOR
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