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Mom Power With High-Adversity Mothers and Children (MPHAMC)

Primary Purpose

Self-regulation, Respiratory Sinus Arrhythmia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mom Power Intervention
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-regulation focused on measuring biobehavioral self-regulation, psychopathology, parenting behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Educare New Orleans
  • Kingsley House Early Head Start Preschool

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Waitlist control

Arm Description

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.

Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
Dyadic synchrony - physiological
Dyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above)
Dyadic synchrony - observational
Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.
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
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.
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.
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
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
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.
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
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

Full Information

First Posted
January 10, 2020
Last Updated
June 1, 2021
Sponsor
Tulane University
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04241913
Brief Title
Mom Power With High-Adversity Mothers and Children
Acronym
MPHAMC
Official Title
A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19 and pandemic-related mitigation strategies, we were forced to alter procedures prior to the enrolling of participants into this trial. We will submit a new protocol for our adapted trial, launching at a later date.
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-regulation, Respiratory Sinus Arrhythmia
Keywords
biobehavioral self-regulation, psychopathology, parenting behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
No masking
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments.
Intervention Type
Behavioral
Intervention Name(s)
Mom Power Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child RSA
Description
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.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Parent RSA
Description
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.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Secondary Outcome Measure Information:
Title
Child Behavior - parent report
Description
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).
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Child Behavior - teacher report
Description
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).
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Dyadic synchrony - physiological
Description
Dyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above)
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Dyadic synchrony - observational
Description
Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Parent psychopathology
Description
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
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Parent emotion regulation
Description
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.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Sensitive parenting behavior
Description
Observational data derived from parent-child interactions will be examined, coding using the Coding Interactive Behavior measure (CIB). Higher scores reflect more sensitivity.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Parent self-efficacy
Description
Parents will report on their own parenting efficacy using the Parent Sense of Competence scale; range: 17-102, higher scores reflect more self-efficacy
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Parenting behavior
Description
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
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Parent mental representation
Description
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.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Child Behavioral Self-Regulation, observational
Description
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
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Child Behavioral Self-Regulation, parent report
Description
Child self-regulation will also be assessed by parent-report (Social Competence Scale - Emotion Regulation); range: 0-48; higher scores reflect higher self-regulation
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Other Pre-specified Outcome Measures:
Title
Maternal social support
Description
Mothers will report on social support (Multidimensional Scale of Perceived Social Support); range: 12-84; higher scores reflect higher perceived support.
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months
Title
Perceived stress
Description
Mothers will report on perceived stress (Perceived Stress Scale-4); range: 0-16; higher scores reflect higher stress
Time Frame
Within 6 weeks of treatment group completion; approximately 4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Child participants can be male or female. Recruited parent must be biological mother due to interest in intergenerational patterns and concerns about heritability of the primary outcome.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah A Gray, PhD
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Educare New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Kingsley House Early Head Start Preschool
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28647759
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/sites/myncbi/sarah.gray.2/bibliography/49443145/public/?sort=date&direction=as
Description
Bibliography of Sarah Gray, PhD

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Mom Power With High-Adversity Mothers and Children

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