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

Tulane University

Status: Completed

Conditions: Psychopathology

Treatments: Behavioral: Mom Power Informational Mailing; Behavioral: Mom Power

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05129397

K23MH119047 (U.S. NIH Grant/Contract)

2018-2012-TU Uptown

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Mom Power

Informational control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mom Power Informational Mailing