NCT05129397

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psychopathology

Interventions

Type	Name	Description
BEHAVIORAL	Mom Power	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.
BEHAVIORAL	Mom Power Informational Mailing	This active comparison condition intervention includes two individual sessions along with 10 weeks of informational mailing with content related to Mom Power core concepts.

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2021-11-22
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States