Mom Power With High-Adversity Mothers and Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children

Conditions
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Self-regulation, Respiratory Sinus Arrhythmia

Intervention / Treatment
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* Behavioral: Mom Power Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Behavioral: Mom Power Intervention<br>* Mom Power is a 10-week therapeutic intervention for at-risk families that incorporates elements of several evidence based practices. It combines didactic material with mindbody self-care skills and in vivo practice to improve the quality of attachment between parent and child, and to reduce the psychopathology of at-risk parents. The child team component provides each child with one-on-one care focusing on meeting the child's social-emotional needs and providing attachment-related experiences within a developmental framework.<br>|
| No Intervention: Waitlist control<br>Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child RSA | 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. | Within 6 weeks of treatment group completion; approximately 4 months | 
| Parent RSA | 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. | Within 6 weeks of treatment group completion; approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior - parent report | 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). | Within 6 weeks of treatment group completion; approximately 4 months | 
| Child Behavior - teacher report | 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). | Within 6 weeks of treatment group completion; approximately 4 months | 
| Dyadic synchrony - physiological | Dyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above) | Within 6 weeks of treatment group completion; approximately 4 months | 
| Dyadic synchrony - observational | Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure. | Within 6 weeks of treatment group completion; approximately 4 months | 
| Parent psychopathology | 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 | Within 6 weeks of treatment group completion; approximately 4 months | 
| Parent emotion regulation | 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. | Within 6 weeks of treatment group completion; approximately 4 months | 
| Sensitive parenting behavior | Observational data derived from parent-child interactions will be examined, coding using the Coding Interactive Behavior measure (CIB). Higher scores reflect more sensitivity. | Within 6 weeks of treatment group completion; approximately 4 months | 
| Parent self-efficacy | Parents will report on their own parenting efficacy using the Parent Sense of Competence scale; range: 17-102, higher scores reflect more self-efficacy | Within 6 weeks of treatment group completion; approximately 4 months | 
| Parenting behavior | 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 | Within 6 weeks of treatment group completion; approximately 4 months | 
| Parent mental representation | 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. | Within 6 weeks of treatment group completion; approximately 4 months | 
| Child Behavioral Self-Regulation, observational | 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 | Within 6 weeks of treatment group completion; approximately 4 months | 
| Child Behavioral Self-Regulation, parent report | Child self-regulation will also be assessed by parent-report (Social Competence Scale - Emotion Regulation); range: 0-48; higher scores reflect higher self-regulation | Within 6 weeks of treatment group completion; approximately 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biobehavioral self-regulation, psychopathology, parenting behavior