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

Study Overview
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Brief Summary
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This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children

Conditions
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Psychopathology

Intervention / Treatment
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* Behavioral: Mom Power
* Behavioral: Mom Power Informational Mailing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The experimental arm of Virtual Mom Power is a manualized multi-family group intervention consisting of 10, 90-minute virtual group + 2 individual sessions led by two co-facilitators. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice; (4) Social Support; & (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. We will work with mothers in individual coaching to problem-solve childcare and privacy during group time. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs. Data regarding attendance will be recorded and total dosage examined in treatment effects. | Behavioral: Mom Power<br>* Virtual Mom Power is a manualized multi-family group intervention consisting of 10 virtual group + 2 individual sessions led by two masters-level co-facilitators. Virtual groups are 90 minutes, following a structured format via secure HIPAA compatible video platform. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice (4) Social Support; & (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs.<br>|
| Active Comparator: Informational control<br>The control arm of this study consists of two individual sessions with mothers, along with 10 weeks of virtual informational mailings. The mailings will contain Mom Power curriculum about attachment-based parenting and self-care. The individual sessions will focus on individual goal-setting related to parenting and reflection on the parent-child relationship. The control group does not include the components of social support, affect regulation skills coaching, or guided parent-child interaction that are part of the experimental arm. | Behavioral: Mom Power Informational Mailing<br>* This active comparison condition intervention includes two individual sessions along with 10 weeks of informational mailing with content related to Mom Power core concepts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline maternal depressive symptoms at post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change from baseline maternal depressive symptoms at 6 month 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. | 6 months (follow up) | 
| Change from baseline maternal posttraumatic stress symptoms at post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change from baseline maternal posttraumatic stress symptoms at 6 month 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. | 6 months (follow up) | 
| Change from baseline child behavior at post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change from baseline child behavior at 6 month 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. | 6 months (follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parenting stress from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in parenting stress from baseline to 6 month follow up | 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. | 6 months | 
| Change in self-report parent child relationship from baseline to post intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in self-report parent child relationship from baseline to follow up | 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. | 6 months | 
| Change in maternal social support from baseline to post intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in maternal social support from baseline to follow up | 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. | 6 months | 
| Change in observed parenting sensitivity from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in Working Models from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in maternal emotion regulation from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in maternal emotion regulation from baseline to follow up | 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. | 6 months | 
| Change in maternal emotion regulation while parenting from baseline to post intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in maternal emotion regulation while parenting from baseline to follow up | 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. | 6 months | 
| Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention | 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) | At completion of intervention, approximately 3 months | 
| Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 
| Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention | 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. | At completion of intervention, approximately 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biobehavioral regulation, Respiratory Sinus Arrhythmia, parenting behavior