Skip to content

Mom Power With High-Adversity Mothers and Children

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04241913
Acronym
MPHAMC
Enrollment
0
Registered
2020-01-27
Start date
2021-06-01
Completion date
2021-06-01
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Sinus Arrhythmia, Self-regulation

Keywords

biobehavioral self-regulation, psychopathology, parenting behavior

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.

Interventions

BEHAVIORALMom Power Intervention

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Mental Health (NIMH)
CollaboratorNIH
Tulane University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Child RSAWithin 6 weeks of treatment group completion; approximately 4 monthsChild 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.
Parent RSAWithin 6 weeks of treatment group completion; approximately 4 monthsParent 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

MeasureTime frameDescription
Child Behavioral Self-Regulation, parent reportWithin 6 weeks of treatment group completion; approximately 4 monthsChild self-regulation will also be assessed by parent-report (Social Competence Scale - Emotion Regulation); range: 0-48; higher scores reflect higher self-regulation
Parent mental representationWithin 6 weeks of treatment group completion; approximately 4 monthsParents 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.
Child Behavioral Self-Regulation, observationalWithin 6 weeks of treatment group completion; approximately 4 monthsChild 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
Child Behavior - parent reportWithin 6 weeks of treatment group completion; approximately 4 monthsChild 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).
Child Behavior - teacher reportWithin 6 weeks of treatment group completion; approximately 4 monthsChild 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).
Dyadic synchrony - physiologicalWithin 6 weeks of treatment group completion; approximately 4 monthsDyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above)
Dyadic synchrony - observationalWithin 6 weeks of treatment group completion; approximately 4 monthsDyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.
Parent psychopathologyWithin 6 weeks of treatment group completion; approximately 4 monthsParents 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
Parent emotion regulationWithin 6 weeks of treatment group completion; approximately 4 monthsParents 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.
Sensitive parenting behaviorWithin 6 weeks of treatment group completion; approximately 4 monthsObservational data derived from parent-child interactions will be examined, coding using the Coding Interactive Behavior measure (CIB). Higher scores reflect more sensitivity.
Parent self-efficacyWithin 6 weeks of treatment group completion; approximately 4 monthsParents will report on their own parenting efficacy using the Parent Sense of Competence scale; range: 17-102, higher scores reflect more self-efficacy
Parenting behaviorWithin 6 weeks of treatment group completion; approximately 4 monthsParents will report on their own parenting behavior using the Conflict Tactic Scales - Parent Child (CTS-PC); range: 0-240, higher values reflect harsher parenting

Other

MeasureTime frameDescription
Perceived stressWithin 6 weeks of treatment group completion; approximately 4 monthsMothers will report on perceived stress (Perceived Stress Scale-4); range: 0-16; higher scores reflect higher stress
Maternal social supportWithin 6 weeks of treatment group completion; approximately 4 monthsMothers will report on social support (Multidimensional Scale of Perceived Social Support); range: 12-84; higher scores reflect higher perceived support.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026