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Mom Power With High-Adversity Mothers and Children

Not Applicable
Withdrawn
Conditions
Self-regulation
Respiratory Sinus Arrhythmia
Interventions
Behavioral: Mom Power Intervention
Registration Number
NCT04241913
Lead Sponsor
Tulane University
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TreatmentMom Power InterventionThe 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.
Primary Outcome Measures
NameTimeMethod
Parent RSAWithin 6 weeks of treatment group completion; approximately 4 months

Parent self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction 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 (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.

Child RSAWithin 6 weeks of treatment group completion; approximately 4 months

Child self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction 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 (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.

Secondary Outcome Measures
NameTimeMethod
Parent psychopathologyWithin 6 weeks of treatment group completion; approximately 4 months

Parents will report on their own depression symptoms (Patient Health Questionnaire-9 and Posttraumatic Checklist - 5); individual scales will be z-scored and summed, with higher values reflecting higher levels of psychopathology

Child Behavioral Self-Regulation, observationalWithin 6 weeks of treatment group completion; approximately 4 months

Child self-regulation will be assessed behaviorally using observation (Preschool Self-Regulation Assessment); children's behavior will be observed during 6 tasks, and codes z-scored and summed; higher scores reflect higher effortful control/executive function

Sensitive parenting behaviorWithin 6 weeks of treatment group completion; approximately 4 months

Observational data derived from parent-child interactions will be examined, coding using the Coding Interactive Behavior measure (CIB). Higher scores reflect more sensitivity.

Parenting behaviorWithin 6 weeks of treatment group completion; approximately 4 months

Parents will report on their own parenting behavior using the Conflict Tactic Scales - Parent Child (CTS-PC); range: 0-240, higher values reflect harsher parenting

Parent mental representationWithin 6 weeks of treatment group completion; approximately 4 months

Parents will complete an abbreviated version of the Working Model of the Child Interview; interviews will be coded into 3 categories, and it is hypothesized that proportion of "balanced" representations will be higher post-treatment.

Dyadic synchrony - physiologicalWithin 6 weeks of treatment group completion; approximately 4 months

Dyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above)

Parent emotion regulationWithin 6 weeks of treatment group completion; approximately 4 months

Parents will report on their own emotion regulation using the difficulties in emotion regulation (DERS; range: 36-180); higher scores reflect more difficulties with emotion regulation.

Child Behavior - teacher reportWithin 6 weeks of treatment group completion; approximately 4 months

Child Behavior problems will be assessed via teacher report with the Teacher Report Form; Achenbach \& Rescorla, 2000. Higher scores indicate higher behavior problems (T score is a standardized score with a mean of 50).

Parent self-efficacyWithin 6 weeks of treatment group completion; approximately 4 months

Parents will report on their own parenting efficacy using the Parent Sense of Competence scale; range: 17-102, higher scores reflect more self-efficacy

Child Behavior - parent reportWithin 6 weeks of treatment group completion; approximately 4 months

Child Behavior problems will be assessed via Total Score on parent report with the Child Behavior Checklist; higher scores indicate higher behavior problems (T score is a standardized score with a mean of 50).

Dyadic synchrony - observationalWithin 6 weeks of treatment group completion; approximately 4 months

Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.

Child Behavioral Self-Regulation, parent reportWithin 6 weeks of treatment group completion; approximately 4 months

Child self-regulation will also be assessed by parent-report (Social Competence Scale - Emotion Regulation); range: 0-48; higher scores reflect higher self-regulation

Trial Locations

Locations (2)

Kingsley House Early Head Start Preschool

🇺🇸

New Orleans, Louisiana, United States

Educare New Orleans

🇺🇸

New Orleans, Louisiana, United States

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