Clinical trial NCT04241913: Mom Power With High-Adversity Mothers and Children
Official title: A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Self-regulation
Respiratory Sinus Arrhythmia
Keywords: biobehavioral self-regulation
psychopathology
parenting behavior
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2020-01-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two arms: an experimental group receiving the Mom Power group intervention over 10 weeks, and a wait list control group. Treatment delivery will be consistent with the Mom Power manual. The waitlist control group will be offered to participate in the intervention following the trial period.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Child RSA
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Parent RSA
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
Secondary outcomes:
measure: Child Behavior - parent report
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Child Behavior - teacher report
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Dyadic synchrony - physiological
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Dyadic synchrony - observational
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Parent psychopathology
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Parent emotion regulation
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Sensitive parenting behavior
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Parent self-efficacy
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Parenting behavior
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Parent mental representation
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Child Behavioral Self-Regulation, observational
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Child Behavioral Self-Regulation, parent report
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
Other outcomes:
measure: Maternal social support
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
measure: Perceived stress
timeFrame: Within 6 weeks of treatment group completion; approximately 4 months
Locations:
city: New Orleans
country: United States
facility: Educare New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Kingsley House Early Head Start Preschool
state: Louisiana
Study officials:
affiliation: Tulane University
name: Sarah A Gray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenblum KL, Muzik M, Morelen DM, Alfafara EA, Miller NM, Waddell RM, Schuster MM, Ribaudo J. A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children. Arch Womens Ment Health. 2017 Oct;20(5):673-686. doi: 10.1007/s00737-017-0734-9. Epub 2017 Jun 25.