Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241913
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sarah Gray, 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.

Condition or disease Intervention/treatment Phase
Self-regulation Respiratory Sinus Arrhythmia Behavioral: Mom Power Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: Treatment
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
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.

No Intervention: Waitlist control
Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Child Behavior - parent report [ Time Frame: Within 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).

  2. Child Behavior - teacher report [ Time Frame: Within 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).

  3. Dyadic synchrony - physiological [ Time Frame: Within 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)

  4. Dyadic synchrony - observational [ Time Frame: Within 6 weeks of treatment group completion; approximately 4 months ]
    Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.

  5. Parent psychopathology [ Time Frame: Within 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

  6. Parent emotion regulation [ Time Frame: Within 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.

  7. Sensitive parenting behavior [ Time Frame: Within 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.

  8. Parent self-efficacy [ Time Frame: Within 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

  9. Parenting behavior [ Time Frame: Within 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

  10. Parent mental representation [ Time Frame: Within 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.

  11. Child Behavioral Self-Regulation, observational [ Time Frame: Within 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

  12. Child Behavioral Self-Regulation, parent report [ Time Frame: Within 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


Other Outcome Measures:
  1. Maternal social support [ Time Frame: Within 6 weeks of treatment group completion; approximately 4 months ]
    Mothers will report on social support (Multidimensional Scale of Perceived Social Support); range: 12-84; higher scores reflect higher perceived support.

  2. Perceived stress [ Time Frame: Within 6 weeks of treatment group completion; approximately 4 months ]
    Mothers will report on perceived stress (Perceived Stress Scale-4); range: 0-16; higher scores reflect higher stress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241913


Contacts
Layout table for location contacts
Contact: Sarah A Gray, PhD 337-852-4889 sgray4@tulane.edu
Contact: Victoria R Parker, B.A 781-733-4989 vparker1@tulane.edu

Locations
Layout table for location information
United States, Louisiana
Educare New Orleans
New Orleans, Louisiana, United States, 70122
Kingsley House Early Head Start Preschool
New Orleans, Louisiana, United States, 70130
Sponsors and Collaborators
Tulane University
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Sarah A Gray, PhD Tulane University
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Sarah Gray, Assistant Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator, Tulane University
ClinicalTrials.gov Identifier: NCT04241913    
Other Study ID Numbers: 2018-2012
1K23MH119047-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Gray, Tulane University:
biobehavioral self-regulation
psychopathology
parenting behavior
Additional relevant MeSH terms:
Layout table for MeSH terms
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes