Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC)

Not Applicable

Completed

• Conditions: Psychopathology

• Registration Number: NCT05129397
• Lead Sponsor: Tulane University

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.

Study Timeline

• Study First Submitted: 2021-10-25
• Study Start: 2021-11-01
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline maternal depressive symptoms at post-intervention	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	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	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	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	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.	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 Outcome Measures

Name	Time	Method
Change in parenting stress from baseline to 6 month follow up	6 months	Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Total Stress scale from baseline to follow up (6 months) will be examined. Higher scores reflect more parenting stress.
Change in parenting stress from baseline to post-intervention	At completion of intervention, approximately 3 months	Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Total Stress scale from baseline to post-assessment (3 months) will be examined. Higher scores reflect more parenting stress.
Change in self-report parent child relationship from baseline to follow up	6 months	Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Parent Child Dysfunctional Interaction scale from baseline to follow up (6 months) will be examined. Higher scores reflect more dysfunction.
Change in maternal social support from baseline to post intervention	At completion of intervention, approximately 3 months	Mothers will report on their perceived social support a using the Multidimensional Scale of Perceived Social Support (MSPSS). Change from baseline to post intervention (3 months) will be examined. Higher scores reflect more social support.
Change in Working Models from baseline to post-intervention	At completion of intervention, approximately 3 months	Mothers and evaluators will complete a Working Model of the Child Interview (WMCI) at baseline and post-intervention (3 months) to assess parents' internal working model classifications. Classifications as Balanced, Disengaged, and Distorted will be used. Classification as balance is considered a more adaptive outcome.
Change in maternal emotion regulation from baseline to follow up	6 months	Mothers will report on their difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Change in the sum score from baseline to 6 month follow up will be examined. Higher scores reflect more difficulties in emotion regulation.
Change in self-report parent child relationship from baseline to post intervention	At completion of intervention, approximately 3 months	Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Parent Child Dysfunctional Interaction scale from baseline to post-assessment (3 months) will be examined. Higher scores reflect more dysfunction.
Change in observed parenting sensitivity from baseline to post-intervention	At completion of intervention, approximately 3 months	Parenting sensitivity will be assessed at baseline and post intervention (3 months) with an observational measure. Video tapes of parent-child interactions during a 5-minute period of free play and a 5-minute period of structured interaction with a challenging puzzle will be coded using the Coding Interactive Behavior (CIB) measure. Parenting sensitivity scales will be used. Higher scores reflect more sensitivity.
Change in maternal social support from baseline to follow up	6 months	Mothers will report on their perceived social support a using the Multidimensional Scale of Perceived Social Support (MSPSS). Change from baseline to follow up (6 months) will be examined. Higher scores reflect more social support.
Change in maternal emotion regulation from baseline to post-intervention	At completion of intervention, approximately 3 months	Mothers will report on their difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Change in the sum score from baseline to post-intervention will be examined. Higher scores reflect more difficulties in emotion regulation.
Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention	At completion of intervention, approximately 3 months	Electrocardiogram data will be collected during a 2 minute baseline neutral video task and a 5 minute parent-child puzzle teaching task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (24-1.04 for children) and log-transformed. Change in children's Respiratory Sinus Arrhythmia reactivity during the puzzle task from baseline to post-intervention will be assessed.
Change in maternal emotion regulation while parenting from baseline to post intervention	At completion of intervention, approximately 3 months	Mothers will report on their parenting-specific behavioral self-regulation (Regulating Emotions in Parenthood). Change in the sum score from baseline to post intervention will be examined.
Change in maternal emotion regulation while parenting from baseline to follow up	6 months	Mothers will report on their parenting-specific behavioral self-regulation (Regulating Emotions in Parenthood). Change in the sum score from baseline to 6 month follow up will be examined.
Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention	At completion of intervention, approximately 3 months	At baseline assessments and at post-intervention assessments, electrocardiogram data will be collected during a 2 minute neutral video tsak. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify respiratory sinus arrhythmia (RSA) within frequency bandwidths associated with respiration (.15-.40 for mothers) and log-transformed. Change in resting RSA from baseline to post-intervention will be examined. Higher resting RSA is expected post-intervention.
Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention	At completion of intervention, approximately 3 months	Electrocardiogram data will be collected during a 2 minute baseline neutral video task and a 5 minute parent-child puzzle teaching task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (24-1.04 for children) and log-transformed. Respiratory Sinus Arrhythmia reactivity in response to the puzzle task will be assessed at baseline and post-intervention (3 months)
Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention	At completion of intervention, approximately 3 months	Electrocardiogram data will be collected during a 2 minute baseline neutral video task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (24-1.04 for children) and log-transformed. Change in children's resting Respiratory Sinus Arrhythmia during the neutral task will be assessed from baseline to post-intervention (3 months). Higher resting RSA is expected post-intervention.

Trial Locations

Locations (1)

Tulane Child and Family Lab; 🇺🇸 New Orleans, Louisiana, United States