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

Tulane University

Status: Withdrawn

Conditions: Self-regulation; Respiratory Sinus Arrhythmia

Treatments: Behavioral: Mom Power Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04241913

1K23MH119047-01 (U.S. NIH Grant/Contract)

2018-2012

Details and patient eligibility

About

This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.

Full description

Adverse childhood experiences (ACEs) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. Biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. However, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. Additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. There is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. The objective of this RCT is to determine whether Mom Power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. The central hypothesis is that the intervention will shift behavioral and physiological (Respiratory Sinus Arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Three specific aims are proposed: 1) Examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) Examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) Examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participants in this study must include a mother-child dyad. There is inclusion and exclusion criteria for both mother and child.

Inclusion Criteria:

• For moms: Mothers must be female, the biological mother, have an ACE score of 3 or more, speak English, and be 18 years or older.
• For children: Children must be between the ages of 2 and 5.

Exclusion Criteria:

• For mothers: No pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (Brown & Rounds, 1995; Degenhardt, Hall, Korten, & Jablensky, 2005).
• For children: No parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment

Experimental group

Description:

The treatment group receives the 10-week, group-based Mom Power intervention; intervention is provided to both mothers and children by trained providers. Treatment delivery will be consistent with the Mom Power manual.

Treatment:

Behavioral: Mom Power Intervention

Waitlist control

No Intervention group

Description:

Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments.