A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Self-regulation
- Sponsor
- Tulane University
- Locations
- 2
- Primary Endpoint
- Parent RSA
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Sarah Gray
Assistant Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator
Tulane University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Parent RSA
Time Frame: Within 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 RSA
Time Frame: Within 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 Outcomes
- Parent psychopathology(Within 6 weeks of treatment group completion; approximately 4 months)
- Child Behavioral Self-Regulation, observational(Within 6 weeks of treatment group completion; approximately 4 months)
- Sensitive parenting behavior(Within 6 weeks of treatment group completion; approximately 4 months)
- Parenting behavior(Within 6 weeks of treatment group completion; approximately 4 months)
- Parent mental representation(Within 6 weeks of treatment group completion; approximately 4 months)
- Dyadic synchrony - physiological(Within 6 weeks of treatment group completion; approximately 4 months)
- Parent emotion regulation(Within 6 weeks of treatment group completion; approximately 4 months)
- Child Behavior - teacher report(Within 6 weeks of treatment group completion; approximately 4 months)
- Parent self-efficacy(Within 6 weeks of treatment group completion; approximately 4 months)
- Child Behavior - parent report(Within 6 weeks of treatment group completion; approximately 4 months)
- Dyadic synchrony - observational(Within 6 weeks of treatment group completion; approximately 4 months)
- Child Behavioral Self-Regulation, parent report(Within 6 weeks of treatment group completion; approximately 4 months)